Kornimate/medical-research-clean huggingface dataset:
gm-csf for reversal of immunoparalysis in pediatric sepsis-induced mods study

Conditions: Pediatric Sepsis-induced MODS

Summary: this study is an open-label, multi-center, interventional trial in which children with sepsis-induced mods undergo surveillance immune function testing beginning on day 2 of mods. those children who demonstrate immunoparalysis (tnf-alpha response \<200 pg/ml) will receive a 7-day course of gm-csf at a dose of 125 or 250 mcg/m2/day by either the intravenous (iv) or subcutaneous (sq) route. the goal of the study is to establish the dose and route of delivery that results in resolution of immunoparalysis (tnf-alpha response \>=200 pg/ml) by the morning after the 3rd scheduled dose with persistent resolution of immunoparalysis on the morning after the 7th scheduled dose. resolution of immunoparalysis in 8 out of the first 10 subjects in a study treatment arm represents a successful dose and route. the goal of this study will be achieved through the following specific aims: specific aim 1. establish the immunologic efficacy of gm-csf administered by the iv and sq routes in children with immunoparalysis in the setting of sepsis-induced mods. specific aim 2. estimate the pharmacokinetic parameters by the iv and sq gm-csf administered in pediatric sepsis-induced mods. specific aim 3. demonstrate the feasibility of screening, enrollment, drug delivery, and sample collection for a multi-center immunostimulation trial in children with sepsis-induced mods.


Eligibility criteria:
inclusion criteria: * \>= 40 weeks gestational age to \<18 years; and * onset of \>=2 new organ dysfunctions (compared to pre-sepsis baseline) as measured by the proulx criteria; and * documented or suspected infection as the mods inciting event. exclusion criteria: * unable to collect a cumulative total of 20.5 ml of blood for this study due to research blood draw limits; or * limitation of care order at the time of screening; or * patients at high risk for brain death; or * active (or planned within 7 days) immunosuppressive treatment for oncologic, transplant, or rheumatologic disease; or * known primary immunodeficiency disorder; or * diagnosis of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia;or * known allergy to gm-csf; or * documented hyperferritinemia (serum ferritin \>= 500 ng/ml) during current sepsis event; or * contraindication to sq injection (ecmo); or * burns where \>5% of the total body surface area is affected; or * renal replacement therapy at the time of screening; or * on ecmo or anticipated to require ecmo; or * known pregnancy; or * inability to collect and ship sample for immune testing on mods day 2; or * previous enrollment in the grace study

Keywords: sepsis mods pediatric immunoparalysis gm-csf
pergolide for cognitive symptoms in schizotypal personality disorder

Conditions: Schizotypal Personality Disorder; Other Personality Disorders

Summary: hypothesis: schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the ax-cpt, n-back and eriksen during pergolide treatment. there will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo. design: randomized, double-blind, crossover study of pergolide vs. placebo. half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.


Eligibility criteria:
inclusion criteria: dsm-iv criteria for schizotypal personality disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease. - exclusion criteria: dsm-iv or rdc criteria for schizophrenia or any schizophrenia-related psychotic disorder or for bipolar disorder. any other axis i disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment. -
mtx and steroid as first-line therapy for agvhd

Conditions: Acute GVH Disease

Summary: the aim of the study is to identify the efficacy and safety of methotrexate (mtx) combined corticosteroid as first-line therapy for acute graft-versus-host disease (agvhd) after allogeneic hematopoietic stem cell transplantation (allohsct).

allo-hsct is an effective treatment of malignant hematopoietic diseases. however, agvhd remains a major complication after allo-hsct and the destruction of recipient tissues by alloantigen-activated t cells is a key event in the development of agvhd. corticosteroid is the standard first-line therapy for agvhd due to their roles in suppressing t cell responses. however, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory gvhd were poor. thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for agvhd. the study hypothesis: mtx combined corticosteroid treatment could help to further ameliorate the activity of t cells and control agvhd.

Eligibility criteria:
inclusion criteria: 1. patients who are fully informed and sign informed consent by themselves or their guardians; 2. patients receiving allogeneic hematopoietic stem cell transplantation; 3. patients with acute graft-versus-host disease of grade ii-iv were diagnosed after transplantation; 4. patients with stable implantation of granulocytes and platelets. 5. ecog score ≤3 exclusion criteria: 1. patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease; 2. patients with uncontrollable active infection; 3. patients with recurrence of primary malignant hematopathy; 4. expected survival is less than 3 months 5. patients who have histories of severe allergic reactions 6. pregnant or lactating women 7. the researcher judges that there are other factors that are not suitable for participating

Keywords: acute gvhd mtx corticosteroid
anesthesic propofol and remifentanil requirements in obese patients

Conditions: Anesthesia; Obesity

Summary: pharmacokinetic models for anesthetic agents are questionable. the objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients


Eligibility criteria:
inclusion criteria: - patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients) exclusion criteria: * age lower than 18 years, * pregnant woman, * presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency, * allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient, * hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl, * allergy to latex, * presence of a symptomatic gastroesophageal reflux, * patients receiving a psychotropic treatment or a agonist-antagonist opiate, * presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity)

Keywords: anesthesia obesity
intermittent catheterisation on the bladder mucosa of healthy volunteers with a micro hole zone catheter

Conditions: Urinary Incontinence

Summary: this investigation is a randomized, single-blinded, parallel, single-center investigation. in total, up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the principal investigator (pi), or designee. each subject will be enrolled in the investigation, which can be up to 3 days (if day 0 and day 1 are not on same day). the subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product.

this investigation is a randomized, single-blinded, parallel, single-center investigation. up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the principal investigator (pi), or designee. each subject will be enrolled in the investigation, which can be up to 3 days (if day 0 and day 1 are not on same day). the subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product. the subjects will undergo cystoscopy and catheterization.

Eligibility criteria:
inclusion criteria: 1. has given written informed consent 2. is at least 18 years and have full legal capacity 3. is female 4. has a negative urine multistix dipstick test for erythrocytes (haematuria) exclusion criteria: 1. has used an internal urinary catheter or cystoscopy within the past month 2. has prior history of bladder surgery 3. is symptomatic and/or on medication for overactive bladder 4. has evidence of ongoing, active, symptomatic urinary tract infection (uti) (assessed by pi, or delegate) 5. is pregnant and/or breast-feeding 6. is participating in other clinical investigations during this investigation 7. is menstruating during study period
civamide nasal solution for the treatment of dry eye

Conditions: Dry Eye

Summary: keratoconjunctivitis sicca (kcs) or dry eye syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. millions of people suffer from one form of the disease or another and its prevalence increases with age. dry eye syndrome sufferers experience a broad range of symptoms including discomfort, irritation, burning, itching, redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue. civamide is a trpv-1 receptor modulator that causes the initial stimulation of neuropeptide release and subsequent desensitization to further stimulation of the trigeminovascular system. this provides a pharmacological rational for intranasal route of administration for disorders mediated by the trigeminal nerve or involving the cranial nerve. in nine clinical studies of civamide nasal solution, over 50% of the nearly 300 patients who received civamide via intranasal administration experienced lacrimation (tearing). this led to the hypothesis that civamide nasal solution might be an appropriate treatment for dry eye syndrome.


Eligibility criteria:
inclusion criteria: 1. patients must be aged 18 years or older. 2. patients must have documented moderate to severe evaporative dry eye syndrome for at least 6 months. 3. patients must have a schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one eye at screening and baseline (day 1). 4. patients must have a calculated overall score on the osdi of \>0.1 with no more than three responses of not applicable (n/a) at screening and baseline (day 1). 5. patients must have normal lid position and closure. 6. women must be post-menopausal ≥ 1 year, or surgically sterilized. if not, a negative urine pregnancy test is required within 14 days of day 1. 7. informed consent must be provided. exclusion criteria: 1. patients with severe inflammatory dry eye syndrome. 2. patients with dry eye syndrome secondary to sjögren's syndrome. 3. patients with schirmer (with anesthesia) of \>8 per 5 minutes in both eyes. 4. patients who are allergic to civamide or any similar products, or excipients of civamide nasal solution 0.01%. 5. patients with history of previous ocular surgery or trauma. 6. patients who require concurrent ocular medication for any eye disorder. 7. patients who have used restasis®, serum tears, or oral omega 3 supplements during the last 30 days or oral cyclosporine during the last 90 days. 8. patients who are receiving or have received within 30 days any experimental systemic medication.

Keywords: dry eye civamide zucapsaicin neuropeptides trpv-1
impact of the covid-19 pandemic on the quality of psychological life (covid-pro-impact)

Conditions: Covid 19; Stress, Psychological

Summary: the covid-19 pandemic is profoundly changing the way people live and work. after the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. the previous asian epidemics have had a lasting impact on the health professionals concerned. in france, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 french hospitals. investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the french regions being impacted in different ways). in addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.


Eligibility criteria:
inclusion criteria: * person over 18 * person exercising a profession in the health field * person having expressed his non-opposition exclusion criteria: * inability to understand the information given and the questionnaire * person deprived of liberty, person under guardianship.
hand hygiene skills using virtual reality

Conditions: Virtual Reality; Hand Washing Behavior

Summary: quasi-experimental, one-group pretest-posttest study evaluated the effectiveness of a virtual reality hand hygiene training program for auxiliary nurses and informal caregivers in colombia

this quasi-experimental, one-group pretest-posttest study evaluated the effectiveness of a virtual reality hand hygiene training program for auxiliary nurses and informal caregivers in colombia. a total of 215 participants (94 auxiliary nurses, 121 informal caregivers) completed the intervention, which included three 15-minute virtual reality training sessions with real-time feedback on hand hygiene technique. data were collected at baseline (pre) and immediately after the virtual reality intervention (post), which included one 15-minute training sessions. variables assessed included hand hygiene performance, error rates, and knowledge assessment. linear mixed-effects models were used to assess changes over time.

Eligibility criteria:
inclusion criteria: * auxiliary nurses, * informal caregivers exclusion criteria: - caregivers (both auxiliary nurses or informal caregivers) with prior healthcare training or experience with virtual reality were excluded

Keywords: virtual reality infection control hand hygiene caregivers
self-myofascial release in the posterior myofascial chain

Conditions: Fasciae (Anatomy)--Inflammation

Summary: the study investigates the relation between different segments of the posterior myofascial chain of the human body. the intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain of the participants, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

the study investigates the relation between different segments of the posterior myofascial chain of the human body. the intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

Eligibility criteria:
exclusion criteria: * pregnant women * musculoskeletal problems in the last month * surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months * psychological or nervous alterations * uncomprehension of the study protocol
the relationship between dietary habit and gastroesophageal flap valve abnormality

Conditions: Healthy Subjects

Summary: gastroesophageal reflux disease (gerd) is commonly seen in western countries; however, it is gaining prevalence in asia countries recently. in addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. hill et al developed a grading system of gastroesophageal flap valve (gefv) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (egd). it is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. one study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. so this study attempted to evaluate the relationship between dietary habit and gefv abnormality. the investigators used a questionnaire regarding the dietary habit to the population undergoing egd in a self-paid health examination.


Eligibility criteria:
inclusion criteria: * the healthy subjects undergo egd in a self-paid health examination in wanfang hospital. exclusion criteria: * none
police covid-19 serosurvey

Conditions: SARS-CoV-2 Infection; Volunteers; Healthy

Summary: the investigators aim to determine the immune status of the employees of the cantonal police of bern against sars-cov-2 over a period of 1 year, and to investigate the risk profile of the study participants and their risk of sars-cov-2 exposure in their working and private environments, as well as to evaluate the use of personal protective equipment at potential exposure instances.

i) to determine the extent of infection with seroprevalence data in the special population of police officers of the canton bern. ii) to determine risk factors for infection by comparing the proportion of seropositivity (infected versus noninfected individuals). the investigators hypothesize that police officers with fieldwork activity will have a higher seroprevalence than will office and administration personnel. the investigators hypothesize that working in the city of bern will be associated with a higher seroprevalence than will working in other geographic areas of the canton (i.e. rural area). iii) to monitor covid-19 antibody titres and neutralizing capacity over time and to associate them with reinfection rates and infection-free intervals in police officers after accidental contact with a proven covid-19 case. the investigators hypothesize that in seropositive individuals, there will be a decreasing dynamic of antibody titres over the one-year study period, and hence, a decrease of neutralizing capacity.

Eligibility criteria:
inclusion criteria: * police officers of the cantonal police of bern volunteering to participate in the study. exclusion criteria: * refusal or inability to give informed consent or contraindication to venepuncture.

Keywords: covid-19 sars-cov-2 antibodies seroprevalence
study to compare survival for astra tech implant system, osseospeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges

Conditions: Jaw, Edentulous, Partially

Summary: the purpose of this study is to evaluate survival for astra tech implant system, osseospeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. primary objective is implant survival rate at 12 months.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * 18 years of age and over * a minimum of 20 stable intra occlusal contacts after planned restoration * in need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25 exclusion criteria: * untreated rampant caries and uncontrolled periodontal disease * use of smoking tobacco at time of inclusion * history of pre-surgical bone augmentation, within 4 months, in the planned implant area * history of extraction without augmentation, within 3 months in the planned implant area * absence of opposing dentition * absence of adjacent (mesial and/or distal) natural tooth * uncontrolled diabetes * known pregnancy at time of inclusion * present alcohol or drug abuse * any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * unable or unwilling to return for follow-up visits for a period of 5 years * unrealistic esthetical demands * unlikely to be able to comply with study procedures according to investigators judgment * already included in this study

Keywords: jaw, edentulous, partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))
mechanisms of stroke in intracranial stenosis

Conditions: Stroke

Summary: the objective of this sammpris-affiliated study is to understand the mechanisms the mechanisms that underlie ischemic stroke recurrence in high-grade intracranial atherosclerotic disease in order to determine predictors of recurrent stroke. mosis will evaluate 6 specific mechanisms of stroke in the medically-treated sammpris cohort: decreased antegrade flow, progression of stenosis, decreased proximal collateral flow, decreased distal collateral flow, impaired cerebrovascular reserve, and artery-to-artery embolism.


Eligibility criteria:
inclusion criteria: * enrolled in the medical arm of sammpris, signed consent exclusion criteria: * for qmra testing: contraindications to mri; for tcd testing, abscence of ultrasonographic windows.

Keywords: symptomatic intracranial atherosclerotic disease enrolled in the medical arm of sammpris