Kornimate/medical-research-clean huggingface dataset:
safety of autologous m2 macrophage in treatment of non-acute stroke patients

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Summary: the purpose of this study is to determine whether m2 macrophages are safe and feasible in the treatment of non-acute stroke patients

our primary hypothesis is that autologous m2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. our secondary hypothesis is that autologous m2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke

Eligibility criteria:
inclusion criteria: * computed tomography confirmed ischemic or hemorrhagic stroke * duration since stroke onset more than 3 and less than 12 months * age between 18 and 75 years old * persistent neurological deficits more than 4 points in nihss stroke scale * signed informed consent exclusion criteria: * the history of previous stroke * seizures * thrombophilias or primary hematological diseases * malignancy * hepatic or renal dysfunctions * hemodynamic or respiratory instability * autoimmune disease * hiv or uncontrolled bacterial, fungal, or viral infections * pregnancy * participation in other clinical trials
evaluation of chest physiotherapy for acute bronchiolitis in toddlers (bronkinou)

Conditions: Viral Bronchiolitis

Summary: the purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.

bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. it is also probably the most common serious illness of childhood lacking evidence-based treatment. evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in france, has never been evaluated. the investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress. comparison(s): the investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.

Eligibility criteria:
inclusion criteria: * child aged 15 days to 24 months * first acute bronchiolitis * indication of hospitalisation * one or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate \> 60/min; pulse oxymetry \< 95%; alimentary intake \< 2/3 of the needs. exclusion criteria: * prematurity (gestational age \< 32 weeks) * brondysplasia * chronic lung disease or congenital heart disease * respiratory distress necessitating admission in the pediatric intensive care unit (picu) * 3 or more chest physiotherapy procedures since hospitalisation * parental refusal * any chest physiotherapy contra-indication

Keywords: acute bronchiolitis chest physiotherapy forced expiratory techniques double blind trial children pediatric respiratory syncytial virus
a study to evaluate the safety and effectiveness of alks 2680 in subjects with narcolepsy type 1 (alks 2680-201)

Conditions: Narcolepsy Type 1

Summary: the purpose of this research study is to assess the safety and efficacy of alks 2680 compared to placebo, including whether participants taking alks 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.


Eligibility criteria:
inclusion criteria: * 18-70 years of age * has a bmi ≥18 and ≤40 kg/m2 * meets the diagnostic criteria of narcolepsy type 1 according to icsd-3-tr guidelines. additionally, meets the following criteria: * is hla-dqb1\*06:02-positive * has residual excessive daytime sleepiness and cataplexy * is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study * is willing to adhere to additional protocol requirements exclusion criteria: * significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator * is currently pregnant, breastfeeding, or planning to become pregnant during the study * is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to screening

Keywords: narcolepsy cataplexy orexin
metabo-lipidomics of the ocular surface for cataract surgery

Conditions: Age-related Cataract

Summary: cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. it represents the most frequently performed surgery in france with more than 800,000 procedures each year. however, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. for example, dry eye disease, very common in the elderly, can be worsened by cataract surgery. the identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care. conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. the aqueous humor is directly accessible at the beginning of the surgery. an approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery. this study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.


Eligibility criteria:
inclusion criteria: * patient with cortico-nuclear and/or subcapsular cataract * age \> or = 50 years * patient affiliated to a social security system * patient agreeing to participate in the study who provided his/her free and informed written consent exclusion criteria: * history of ocular surgery or trauma (≤ 3 months) * other types of cataract excepted age-related or diabetic cataract * any eye drops or treatments that may interfere with the ocular surface * lens wearer * any general pathology with a known impact on the ocular surface (auto-immune disease, allergy) * proven allergy to povidone-iodine or to a component of the postoperative treatment * patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom * patient unable to understand the nature and objectives of the study

Keywords: ocular surface cataract conjunctival impression cytology aqueous humor metabolomic lipidomic
a mindful community for people with als and their primary caregivers

Conditions: Amyotrophic Lateral Sclerosis; Caregiver Burden

Summary: the psychological impact of als on patients and caregivers is high, significantly affecting their quality of life (qol). despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve qol. the efficacy of mindfulness-based treatments for the improvement of qol was previously demonstrated by the investigator's group. despite preliminary positive results, treatment efficacy tends to weaken over time. the investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness. this project's primary aims are 1) to develop a "mindful" online community of people with als and their caregivers, and 2) to test its efficacy in qol improvement. this two-part intervention consists of 1) optimizing the investigator's prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.


Eligibility criteria:
inclusion criteria: for the als patients * a definite, probable, laboratory-supported, or possible als by revised el-escorial criteria * they must have the physical ability, with or without adaptive devices, to use a smartphone, a tablet, or a computer * have access to the internet. for the caregivers * be the person who resides with the als patient and is the major provider of unpaid care and assistance (typically, the spouse or another close relative) * s/he must be able to use the application * have access to the internet. exclusion criteria - using shared devices. patients and caregivers should have their own devices.

Keywords: mindfulness quality of life
the effect of physical therapy intervention on motor performance in bhutanese preterm infants

Conditions: Infant, Premature

Summary: the purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in bhutanese preterm infants.the main question the study aims to answer is: will physical therapy intervention improve the motor performance of preterm infants at 3 months of corrected age when compared to the preterm infants receiving standard care of parental education? in this study the motor performance of the preterm infants receiving physical therapy intervention and standard care will be compared.

after receiving parental consent, preterm infants meeting the eligibility criteria will be enrolled for the study. 28 preterm infants will be enrolled and followed up from 40 weeks till 3 months of corrected age. the preterm infants in the intervention group will receive modified supporting play, exploration and early development intervention(speedi) and the standard group will receive standard care. the intervention for both groups will be provided by the physical therapists. the speedi intervention should be carried out by the parent for at least 20mins/day for 5 days in a week. the parent will be asked to bring the infants for monthly follow up. the motor performance of the preterm infants from this two groups will be assessed at 40 weeks, 1, 2 and 3 months of corrected age. the measurement tool that will be used to assess the preterm infants are test for infant motor performance(timp) and rapid neurodevelopment assessment(rnda). the assessment will be performed by therapist who will be blinded to the group allocation. the end point of the study is at 3 months of corrected age.

Eligibility criteria:
inclusion criteria: * infants born between 28 -34 weeks of gestation * medically stable and off ventilator at the time of discharge from the hospital * parents who consent to come for follow up exclusion criteria: * cortical blindness or retinopathy of prematurity causing blindness * musculoskeletal/congenital abnormalities * brain injuries including intra-ventricular hemorrhage (grade 3 and above), hypoxic ischemic encephalopathy and hydrocephalus * genetic syndrome * family who do not consent * parent with physical and psychological problems * infants with medical devices such as ng tube and gastrostomy * infants who have undergone major surgery
diagnostic accuracy of a specialized pro forma in assessing morbidly adherent placenta with correlation to intra-operative findings

Conditions: Morbidly Adherent Placenta

Summary: this study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of morbidly adherent placenta, its extent and its correlation with intraoperative findings.


Eligibility criteria:
inclusion criteria: * age group 28:42 years. * pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks). * with a single living fetus in the current pregnancy. * a previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation) * having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment. exclusion criteria: * cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta. * maternal chronic medical disorders( diabetes mellitus, hypertension) * patients presented with severe attack of bleeding. * patients presented with rupture of membrane. * emergency delivery regardless the cause.
wound fluid protease levels during use of novel wound dressing

Conditions: Venous Stasis Ulcers

Summary: this study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. the investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.

abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. in this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. the findings will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * diagnosis of venous insufficiency * one or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection * ankle/brachial index 0.8 and above * duration of wound up to one year * able to return to wound clinic for weekly evaluations * has signed institutional review board approved informed consent exclusion criteria: * exposed bone or tendon or necrotic wound base * signs or symptoms of cellulitis or osteomyelitis at the target ulcer * allergy to a component of the novel dressing or compression wrap * third degree burn * vasculitis, severe rheumatoid arthritis or other collagen vascular disease * receiving antibiotics * pregnant or lactating
123i-bmipp spect analysis for decreasing cardiac events in hemodialysis patients

Conditions: Coronary Disease; Fatty Acids, Unsaturated; Radioisotopes; Hemodialysis; Single Photon Emission Computed Tomography

Summary: the aim of this multi-center study is to determine the applicability of bmipp to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.


Eligibility criteria:
inclusion criteria:adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease * hypertension * diabetes mellitus * hyperlipidemia * obliterative arteriosclerosis in the lower extremities * smoker * family history of juvenile coronary artery disease * history of ischemic stroke * history of heart failure requiring hospitalization * within 3 months after initiation of hemodialysis therapy * dialysis hypotension exclusion criteria:hemodialysis patients who meet any one of the following conditions will be excluded. * peritoneal dialysis * severe valvular disorder requiring treatment * diagnosis of hypertrophic cardiomyopathy(hcm) or dilated cardiomyopathy(dcm) before start of dialysis * history of revascularization(pci, cabg) or prior diagnosis of myocardial infarction * hypersensitivity to bmipp or its analogue * judged unsuitable for the study for any other reasons by physicians.

Keywords: myocardial free fatty acid metabolism high risk patients end-stage renal failure cardiovascular events prognosis
effect of different fiber breakfasts on appetite and weight change in overweight subjects

Conditions: Obesity

Summary: regular breakfast consumption may help lower body weight reduce body fatness and improve cardiovascular disease risk factors. however, the best kind of breakfast to consume to achieve these effects is unclear. we hypothesized that a high fiber breakfast would suppress appetite, lower body weight and improve cardiovascular disease risk factors compared with a no-fiber breakfast.

participants will report to the hospital cafeteria between 0800 and 0900h following an overnight fast every weekday for 4 consecutive weeks. on arrival, participants will be provided will the allocated breakfast and will be given 15 min to consume all the foods provided. the oatmeal breakfast will consist of 80g dry oatmeal (quaker quick oats) prepared with 120ml fat-free milk and 230ml water. the frosted flakes breakfast will consist of 62g frosted flakes and 160ml whole milk and 190ml water served on the side. the no-breakfast (control) will consist of only 350ml plain water. all participants will also receive 200ml decaffeinated coffee with 12ml non-dairy creamer and 1g packet of non-caloric sweetener. on friday of each week participants will be provided with two portions of the breakfasts to take home at consume on the weekend days. on the first day of the intervention and weekly thereafter participants will complete 3hr subjective appetite ratings responses to the breakfast. laboratory assessments including body weight, composition, blood pressure and a fasting blood sample will be collected before the start of the intervention and at the end of the intervention.

Eligibility criteria:
inclusion criteria: * bmi \>27kg/m2 * weight stable (\<5% weight change in past 3 months) exclusion criteria: * smokers * regular use of medications * currently undertaking a weight-loss or exercise program * females who are pregnant or lactating

Keywords: breakfast oatmeal appetite cholesterol
ultrasonography in children with first febrile urinary tract infection

Conditions: Urinary Tract Infections

Summary: in recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (futi) in children, including kidney ultrasound (kus), cystography (vcug) and renal scintigraphy in order to exclude underlying kidney anomalies. the majority of guidelines, continue to recommend a routine kus for all children at the first futi. on the other hand, as this approach is not based on robust evidence, other guidelines suggest that kus should only be performed on selected patients according to specific risks. despite being a non-invasive and radiation-free method, kus tests negative in 83% of cases of futis and possesses low specificity for low grade vesico-ureteral reflux (vur). since vur is the most commonly associated renal malformation with uti, it is evident that all the guidelines focus on the research of vur, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (cakut). however, vur-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. to reduce the number of normal vcugs performed, recent evidence regarding vur suggests that the presence of pathogens different from e. coli and uti recurrence may help to identify children who necessitate further investigations. a preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first futi who subsequently underwent us evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of uti exhibits a 85% sensitivity to detect pathological ultrasound. the aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of uti in predicting the positivity of kus in children aged 2 months to 3 years old with first episode of futi


Eligibility criteria:
inclusion criteria: - patient with first episode of futi that subsequently do kus. exclusion criteria: * patients with previous episodes of utis * patients on antibiotic prophylaxis * previous finding of malformative uropathies or cystic disease * prenatal diagnosis of cakut with the following parameters: presence of oligohydramnios, alterations in renal number, location and echo structure, bladder alteration, dilations of the renal pelvis and ureters

Keywords: urinary tract infection kidney ultrasound congenital anomalies of the kidney and urinary tract
alcohol impaired driving: from the laboratory to the natural environment

Conditions: Drinking and Driving

Summary: this project combined laboratory and ambulatory assessment (aa) methods to test decision making associated with alcohol impaired driving (aid). participants will complete a laboratory alcohol administration session followed by 6 weeks of mobile assessment. data from drinking events will be examined to test how individuals make choices about driving or not after consuming alcohol.

building on laboratory findings from the the pi's (mccarthy) previous work, this project is designed to test aid decision making in both the lab and the natural drinking environment in which aid decisions are made. participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. the ambulatory assessment component will include participant report via smartphone, portable breathalizer (bactrack), and location and movement data passively collected by the smartphone gps/accelerometer. the combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., brac, calculated drinking location) data for each drinking episode. aim 1 of the project is to test laboratory measures as prospective predictors of aid and examine the role of event-level influences on specific aid decisions. aim 2 of the proposed project is to test the potential for a novel intervention to reduce aid using mobile technology. participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. the timing of the introduction of aa will also be manipulated within the full ambulatory assessment condition. this design will allow us to test whether the introduction of ambulatory assessment produces changes in aid behavior, as well as whether such changes persist once ambulatory assessment is discontinued. changes made to the revised application are aimed at ensuring the achievement of both study aims. if aim 2 is achieved and ambulatory assessment alters aid behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test aim 1 hypotheses.

Eligibility criteria:
inclusion criteria: * moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english exclusion criteria: * not in treatment for substance use disorder or other psychiatric disorders bmi under 30 no medical conditions contraindicating alcohol consumption

Keywords: alcohol impaired driving decision making drunk driving ambulatory assessment