Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of time-restricted feeding (trf) in acute ischemic stroke patients

Conditions: Fasting

Summary: many preclinical studies have demonstrated the beneficial effects of intermittent fasting (if) in a wide range of neurological and cardiovascular diseases. this pilot study aims to investigate the safety and compliance as well as efficacy of one specific if intervention called time-restricted feeding (trf; 16 hours fasting daily) in patients with acute ischemic stroke (ais).

specific aims this project is to conduct a pilot, phase ii randomized clinical trial which aims to investigate the safety and compliance as well as efficacy of one specific if intervention called time-restricted feeding (trf; 16 hours fasting daily) in patients with acute ischemic stroke (ais) the primary endpoint is the safety and compliance of 4 weeks of trf in ais patients. the secondary endpoints are the efficacy of 4 weeks of trf compared to normal eating (ne) on plasma and imaging biomarkers and functional outcome at 3 months post-stroke. this study will determine whether compared to ne control: 1. trf (16 hours fasting daily) is safe and well-tolerated in patients with ais. 2. trf improves functional outcome compared to ne in ais patients. (3) trf decreases plasma pro-inflammatory cytokines including metallopeptidase (mmp)-9, interleukin (il)-6, and tumor necrosis factor alpha (tnf) in plasma compared to baseline and ne in ais patients. (4) trf improves diffusion tensor imaging on mri at 3 months post stroke compared to baseline and ne in ais patients. (5) trf changes plasma exosome components, metabolomics and lipidomics compared to baseline and ne in ais patients.

Eligibility criteria:
inclusion criteria: 1. patients with acute ischemic stroke onset within 10 days 2. age between 20-80 years. 3. mild stroke severity (nih stroke scale ≤ 6). exclusion criteria: 1. large hemispheric (\> 1/2 middle cerebral artery territory) or cerebellar (\>3 cm in diameter) infarct 2. receiving intravenous rt-pa (alteplase) or endovascular thrombectomy 3. severe stenosis (\> 50%) or occlusion of intra/extra cranial arteries corresponding to acute ischemic stroke territory. 4. body mass index ≤ 24. 5. active cancer. 6. diabetes mellitus (ex. hba1c \> 7% or taking oral hypoglycemic agent or insulin) 7. active gastrointestinal bleeding. 8. active infection, concurrent steroid usage or specific endocrine disorders. 9. pre-stroke modified rankin scale \> 2 10. not willing to participate the trial.

Keywords: fasting safety compliance ischemic stroke time restricted feeding
the effect of oculo-motor exercises in intermittent exotropia

Conditions: Intermittent Exotropia; Exercises

Summary: in childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. this situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. patients' hesitant attitudes towards surgical treatment led to the out-of-surgery techniques such as exercise therapy. no studies have been found in the literature on the efficancy of the intermittent exotropia treatments with oculo-motor exercises. in our study, it was aimed to investigate the effects of oculo-motor exercises on intermittent exotropia in children.

50 volunteer school-aged children between 2-17 years of age) were included in our study. oculo-motor home exercise protocols were given to all participants for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. participants were assessed cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis test and patient satisfaction levels by intermittent exotropia survery.

Eligibility criteria:
inclusion criteria: * be between 2 and 17 years of age * intermittent exotropia diagnosis * to have mental capacity in the level to understand and do exercises exclusion criteria: * not complying with age criteria * constant exotropia * having undergone eye surgery * those with systemic disease that prevent exercise

Keywords: intermittent exotropia oculo-motor exercises physiotherapy intermittent exotropia survey
effect of autologous cord blood mononuclear cells for digestive system in preterm neonates

Conditions: Neonatal Necrotizing Enterocolitis; Growth and Development; Preterm Infants; Nutrition

Summary: pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease. this single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood mncs (acbmncs) in preventing nec in preterm neonates,and influence on growth and development.

study design and settings: this study will be a randomized, placebo-controlled, double-blinded, single-center trial. a total of 45 singleton preterm infants (gs\<33 weeks) of fulfilling the eligibility criteria will be enrolled. according to the infusion of umbilical cord blood mononuclear cells and equal dose placebo, the premature infants were divided into infusion group and control group. the two groups were matched with gender, gestational age and birth weight as stratified variables and 1:2 (the gender was the same, and the difference between gestational age and birth weight was the smallest). trial treatment methods: study design and settings: this study will be a randomized, placebo-controlled, double-blinded, single-center trial. a total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. subsequently, one baby of each twin will be randomly divided into the acbmnc infusion group or control (placebo) group. trial treatment methods: soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine treatment. those assigned to the acbmnc group received an infusion of acbmnc . those in control group received an infusion of a placebo solution. informed consent before birth is signed. preterm infants in the acbmnc infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through guangdong province umbilical cord blood bank to obtain mesenchymal stem cells. within 24h after birth, acbmnc group received an infusion of mesenchymal stem cells timely, while control (placebo) group received an infusion of a placebo solution which is normal saline with the same volume. cell dose for all patients was targeted at 5×107 cells per kilogram.

Eligibility criteria:
inclusion criteria: (1) born at the study hospital; (2) singleton birth; (3) 26\<ga \<32 weeks; (4) free of severe congenital anomalies or genetic syndromes; exclusion criteria： (1) mothers with clinical chorioamnionitis; (2) the mother was opsitive for hepatitis b (hbsag and/or hbeag), hepatitis c (anti-hcv), syphilis, hiv (anti-hiv-1 and -2), and igm against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (3) consent was not obtained from the parents or guardians; and (4) after processing, ucb cells were not available.

Keywords: necrotizing enterocolitis preterm infants prevention cord blood mononuclear cells
retrospective clinical outcome of parotid tumor surgery

Conditions: Parotid Tumors; Postoperative Complications

Summary: the aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of parotid tumor * patients received the surgery of parotid tumor at ntuh by single surgeon ( prof. lou) from 2004/01 to 2012/12 exclusion criteria: -inflammation or infection disease of parotid gland

Keywords: parotid tumor partial superficial parotidectomy facial palsy
ayurveda as prophylaxis for suspected covid-19 patients

Conditions: Covid-19

Summary: despite worldwide efforts to contain, manage and treat covid-19, the pandemic is continuing to spread. this calls for an urgent clinically-proven prophylaxis and therapeutic strategy. recent developments on the use of traditional medicines in covid-19 management has drawn enough attention to start several research studies. based on the indian traditional medicine, ayurveda's community initiatives, preliminary studies, and our experiential knowledge on covid-19 settings, we propose present study to prevent the development of covid-19 symptoms in people who live or have come contact with an individual diagnosed with covid-19.


Eligibility criteria:
inclusion criteria: * person who has come into contact with confirmed covid-19, * willing to take study drug as directed exclusion criteria: * confirmed current covid-19 * inability to take medications orally * inability to provide written consent

Keywords: ayurveda
safety and tolerability of liraglutide in healthy japanese volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in japan. the aim of this trial is to assess the safety and tolerability of liraglutide in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * healthy * japanese * body mass index (bmi) between 18 and 27 kg/m\^2 inclusive exclusion criteria: * any clinical laboratory values deviated from the reference range at the laboratory * presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive * history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders. * history of significant allergy or hypersensitivity * known or suspected allergy to trial product or related products. * history of drug or alcohol abuse * smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure
predictive value of qor15 for complications

Conditions: Complication,Postoperative; Postoperative Period

Summary: surgical operations and recovery after anesthesia is a complex process. studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. in this study, the quality of recovery 15 (qor - 15) questionnaire that measures the recovery score, and the american college of surgeons surgical risk calculator have been used to compare the predictive values of patient's preoperative condition on postoperative recovery period and possible morbidity and mortality.

surgical operations and recovery after anesthesia is a complex process. studies examining the interventions performed in the preoperative period often focus on classical clinical outcomes such as postoperative organ dysfunction, morbidity or complications. postoperative recovery of the patient is rarely considered the most important outcome variable in interventional studies. in this study, the effects of both preoperative patient condition and postoperative recovery on morbidity and mortality are investigated. in order to evaluate the ability of qor - 15 to predict postoperative complications patients who underwent major abdominal surgery, patients answer the quality of recovery 15 questionnaire both in the preoperative and postoperative periods. in addition, the risk of postoperative complications is calculated in the preoperative period with the american college of surgeons (acs) surgical risk calculator. finally, postoperative complications of all patients are recorded according to clavien dindo classification. the primary goal is to understand the predictive value of the qor15 score on postoperative complications. secondarily, it is to compare of predictive values of qor15 with acs risk calculator on morbidity and mortality. another secondary aim is to investigate the effect of preoperative conditions of patients on postoperative recovery.

Eligibility criteria:
inclusion criteria: all the patients who undergone major gis surgery exclusion criteria: 1. patients who has an expected mortality in six months because of the primary disease 2. patients who received parenteral nutrition before surgery 3. patients who has a previous major abdominal surgery 4. patients who do not accept the surgery 5. patients with a disability who require a nursing care

Keywords: postoperative morbidity postoperaitve mortality qor15 acs risk calculator recovery
veterans coordinated community care (3c) study

Conditions: Suicide

Summary: veterans coordinated community care (3c) study will recruit 850 veterans at risk for suicide post inpatient hospitalization. each participant will be randomly assigned to treatment as usual (tau) or tau plus the coping long term with active suicide program (clasp), with follow-up for 6 months after discharge. outcomes include suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) and suicidal ideation and functioning.

suicide is a problem of great public health importance. the great majority of suicides occur among people with psychiatric disorders, and among psychiatric patients, those recently discharged from psychiatric hospitalization have highest suicide risk. intensive post-discharge case management programs have been shown to reduce post-discharge suicides, but the rarity of these events even among recently-hospitalized patients makes it infeasible to argue for universal implementation of intensive post-discharge case management. researchers propose to address this problem by carrying out a pragmatic trial among psychiatric inpatients in the veterans health administration (vha) healthcare system judged to be at high risk of post-discharge suicide (based on a validated prediction model). researchers will evaluate the effects of a scalable remote post-discharge moderate intensity adjunctive intervention, the coping long term with active suicide program (clasp), and carry out a heterogeneity of treatment effects (hte) analysis to determine how these effects vary as a function of patient characteristics and features of the post-discharge treatment environment. patients in the clasp treatment will be asked to nominate a significant other (so) to participate in the program with them. so participation is optional. the aim of this research is to conduct a multi-site randomized controlled trial (n=850) of the clasp intervention compared to treatment as usual for veterans at risk for suicide post inpatient hospitalization. assessments will occur at baseline and 6 months post discharge. medical, administrative, and vital records will be obtained for each participant. the primary outcome of this study will be post-discharge suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) in the 6 months post-discharge. researchers will also evaluate secondary outcomes involving patient suicidal ideation and functioning.

Eligibility criteria:
inclusion criteria: * inpatient veteran at high-risk for post-discharge suicide (as flagged by the study's validated prediction model) * 18 years or older * access to a telephone after discharge. exclusion criteria: * impaired decision-making capacity * limited or no english language proficiency * terminal illness

Keywords: veterans suicide prevention behavioral symptoms case management
study of alternate formulation of aripiprazole in agitated patients with schizophrenic disorders

Conditions: Schizophrenia

Summary: study to learn if the alternate formulation is effective in agitated schizophrenic patients


Eligibility criteria:
inclusion criteria: * agitated schizophrenic patients

Keywords: agitated schizophrenic patients
preterm birth cohort study in guangzhou

Conditions: Preterm Birth; Neurodevelopment; Immune Development; Host and Microbiome

Summary: the preterm birth cohort study in guangzhou (pbcsg) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

preterm birth has become the leading cause of neonatal death and the second leading cause of death among children under five years of age. preterm childrens are more susceptible to adverse health problems including brain injury and neurodevelopment delay, and are at risk of chronic diseases which could impair the health status and life quality later in life. however, the causes of preterm birth is still not clear, and there are no effective prediction and preventive strategies. the preterm birth cohort study in guangzhou (pbcsg) will collect the epidemiological,clinical information and biological specimens including maternal blood,cord blood, placenta, children's blood and stool samples of preterm childrens and their mothers. more importantly, childrens' health status, physical and neurodevelopment will be followed up to late childhood and adolescence. the preterm birth cohort would help to explore the mechanism of preterm birth and to examine the short- and long-term influence of preterm birth on physical health and neurodevelopment of childrens.

Eligibility criteria:
inclusion criteria: 1. born before 37 weeks of gestation 2. born in guangzhou women and children's medical center 3. intended to remain in guangzhou for more than 3 years exclusion criteria: 1. multiple birth 2. stillbirth 3. with major congenital abnormalities

Keywords: preterm cohort early development child
insight into hippocampal neuroplasticity in schizophrenia by investigating molecular pathways during physical training

Conditions: Schizophrenia; Neuronal Plasticity; Exercise

Summary: aerobic endurance training has shown positive effects on symptoms, cognition, daily functioning, and the structure of the hippocampus in patients with schizophrenia. the study investigates genetic and epigenetic influences on neuroplastic changes following three months of endurance training. a control group performs flexibility, strength, and balance training. the main objective is to examine the association between a genetic risk score for schizophrenia and volume increase in the ca4/dg region of the hippocampus. additional goals include examining changes in synapses, brain structure, function, and metabolism, as well as clinical symptoms and cognitive performance.


Eligibility criteria:
inclusion criteria: * written informed consent for voluntary study participation. * patients with schizophrenia: diagnosis of schizophrenic psychosis according to icd10 and dsm v, * positive and negative syndrome scale (panss) total score ≤ 75 before the start of the intervention * reliable contraception in women of childbearing age * patients must have been treated with individualized medication according to valid treatment guidelines. all antipsychotic substances are allowed, also as depot medication. treatment with one as well as with two antipsychotic substances is possible. the additional administration of low- and medium-potency antipsychotic substances as on-demand medication for the treatment of agitation and sleep disorders is possible, provided that the daily dosage of 150 cpz units is not exceeded. the active substance and dose of the individualized antipsychotic medication used to achieve the inclusion criterion of psychopathological symptom remission must be constant for at least 2 weeks before inclusion in the study. exclusion criteria: * lack of reliability and sanity (examined by an independent psychiatrist) * positive urine drug screen for illicit drugs (except benzodiazepines) * acute suicide risk * other relevant psychiatric axis-i disorders according to the diagnostic testing procedure (mini international neuropsychiatric interview, mini) * other relevant neurological or other disorders * pregnancy or lactation
the social regulation of threat-related vigilance and arousal

Conditions: Psychological Trauma, Historical; Discrimination, Racial; Emotion Regulation; Social Interaction; Hypervigilance; Anxiety

Summary: this study will examine the effects of social support on threat vigilance and arousal using eye tracking. we will also test the moderating effects of trauma and discrimination history.

both interpersonal trauma (ipt) and ethno-racial discrimination amplify risk for hyper-arousal symptoms of posttraumatic stress disorder (ptsd), but the mechanism of this effect is unclear. prior research suggests that social support plays an important role in regulating emotional responses, a process called social emotion regulation. this study will test whether a history of ipt and/or ethno-racial discrimination influence the social regulation of arousal and vigilance. social regulation will be tested by contrasting responses under conditions with and without social support.

Eligibility criteria:
inclusion criteria: * in a stable romantic relationship for 6 months or more * normal vision or corrected-to-normal vision * fluent in english exclusion criteria: * if vision is corrected-to-normal, needs to use hard contact lenses, bifocal contact lenses, or glasses * experienced a traumatic event within the past 4 weeks

Keywords: psychological trauma ethnoracial discrimination hypervigilance anticipated threat social emotion regulation social touch
clinical performance of a silicone hydrogel for daily disposable wear

Conditions: Refractive Error

Summary: the purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.


Eligibility criteria:
inclusion criteria: * able to understand and sign an irb-approved informed consent form; * successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months: * manifest cylinder of ≤ 0.75 diopter (d) in each eye; * best corrected visual acuity (bcva) of 20/25 or better in each eye; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * history of refractive surgery or plan to have refractive surgery during the study; * ocular or intraocular surgery within the previous 12 months or planned during the study; * current or history of pathologically dry eye in either eye that, in the opinion of the investigator, would preclude contact lens wear; * any previous or current wear of myday; * habitually wearing monovision or multifocal lenses during the last 3 months; * routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment; * any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * other protocol-defined exclusion criteria may apply.

Keywords: contact lens, silicone hydrogel, daily disposable, visual acuity