cyrilzakka/clinical-trials huggingface dataset:
Respiratory Effects of Dopamine in the Perioperative Care

Dopamine is frequently used as an inotropic drug to elevate cardiac output. In addition to the beneficial cardiac effect of this drug, the few previous studies addressing its ability to alter the airway tone reported controversial results.

Thus, the investigators aimed at clarifying the potential of dopamine to alter gas exchange outcomes and the airway tone in patients undergoing cardiac surgeries with cardiopulmonary bypass.

Blood gas parameters, airway resistance, tissue damping and tissue elastance will be measured in the patients before the CPB, immediately after CPB, and 5 min after administration of dopamine (3 mcg/kg/min).

The importance of the research is to reveal whether the beneficial mechanical changes after dopamine administrations are associated with improvements in gas exchange outcomes. Clarification of this research question have scientific relevance and may also improves patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Cardial surgery patients undergoing cardiopulmonary bypass procedures

Exclusion Criteria:

* Chronic respiratory diseases, elderly (\>80 years)
Clinical Evaluation of the VIPUN Balloon Catheter 0.1

The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Aged between and including 18 and 65 years
* BMI between and including 18 and 25
* Understand and able to read Dutch
* In good health on the basis of medical history
* Able to return home without driving a vehicle on visit days 1-4
* Will not operate machines on the same day of treatment (visits 1-4)
* Females subjects of childbearing potential are willing to use adequate contraception
* Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria:

Exclusion criteria related to possible influence on end-points:

* Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
* Using any medication that might affect gastric function or visceral sensitivity
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator

Exclusion criteria related to positioning of the catheter:

* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal, upper GI or esophageal surgery in the last 30 days
* Suspected basal skull fracture or severe maxillofacial trauma
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices

Exclusion criteria related to codeine administration:

* History of opioid dependency
* Known severely decreased kidney or liver function
* Pregnant or breastfeeding women (pregnancy test will be performed on females with childbearing potential)
* Known severe lung disease (e.g. asthma or emphysema)
* Have known side-effects/allergic reactions when taking codeine/morphine
* Known diabetic, fructose intolerance or malabsorption of glucose or galactose or sucrose-isomalase insufficiency.

Exclusion criteria related to Sirupus simplex administration:

• Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and methyl- and propylparahydroxybenzoate

Exclusion criteria related to nutrients (Fortimel):

• Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Fortimel Energy
Microbiome and Exacerbations in Neutrophilic Asthma

Neutrophilic asthma (NA) is the least known severe asthma phenotype. It is associated with more exacerbations, worse control and impaired lung function. One of its possible etiologies is bronchial infections. The study of bronchial microbiology and its relationship with exacerbations is a new line of research.

Objectives: 1) To analyze bronchial microbiome in patients with AN and non-neutrophilic (ANN), with frequent exacerbations and without exacerbations. 2) To relate the presence of bronchial infections with differences in the microbiome. 3) Correlate the characteristics of the microbiome with other evidence used in exacerbations.

Methods: Prospective study involving 40 non-smoking asthmatics without bronchiectasis (20 with AN and 20 with ANN). Of these, 10 in each group will have frequent exacerbations (\>2 rounds of systemic steroids in the last year, of \>3 days each) and 10 non- frequent exacerbations. AN will be defined as \>65% neutrophils in stable phase sputum. All patients will have two stable visits in which clinical variables, asthma control, lung function and induced sputum samples will be collected (for analysis of bronchial inflammatory cell count and for the study of the microbiome by 16 subunit rRNA). Specific Immunoglobulin A (IgA) for Chlamydia Pneumoniae will be determined. In exacerbations, sputum samples will be collected for culture and nasopharyngeal smears for the study of major respiratory viruses and bacteria by multiple polymerase chain reaction.

See above

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 -80
* Confirmed diagnose of asthma
* Severe persistent asthma

Exclusion Criteria:

* Respiratory infection during the previous month
* Other significant lung disease
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.


Eligibility Criteria:
Inclusion Criteria:

1. Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
2. No prior therapy for AML, except for hydroxyurea, in this setting is allowed.
3. Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents
4. Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations
5. Age ≥18 years
6. ECOG PS 0 - 2
7. Adequate liver function, defined as normal total bilirubin, ALT ≤2.0x ULN, and AST ≤2.0x ULN measured within 24 hours prior to crenolanib commencement
8. Adequate renal function, defined as serum creatinine ≤1.5x ULN or GFR \>50 mL/min
9. Negative pregnancy test (serum or urine) for women of childbearing potential (WOCBP)

   • Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months or with bilateral tubal ligation
10. WOCBP must practice contraception. Acceptable methods of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligations, and abstention
11. Male patients (except those with prior surgical contraceptive procedures) with female partners who are of childbearing potential: Recommendation is for male and partner to use effective contraceptive methods, such as latex condoms, during the study
12. Able and willing to provide written informed consent

Exclusion Criteria:

1. Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.)
2. Active CNS leukemia
3. Subject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
4. NYHA Class III-IV heart failure, myocardial infarction \<6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy
5. Unable to swallow pills
6. Major surgical procedures within 14 days of administration of crenolanib (does not include line placement as needed for chemotherapy administration).
7. Unwillingness or inability to comply with protocol.
8. Concurrent use of other investigational agents.
9. Subjects who are not eligible for standard chemotherapy
A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.


Eligibility Criteria:
Inclusion Criteria:

* In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests
* Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit
* Sero-suitable for challenge virus

Exclusion Criteria:

* Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study
* Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI
* Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry
* History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.
* History suggestive of respiratory infection within 14 days prior to admission to the unit
The Influence of Energy Density and Information on Meal Intake in Adults

The purpose of this study is to gain a better understanding of how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).


Eligibility Criteria:
Inclusion Criteria:

* Ability to attend all test meals
* Be fully vaccinated against COVID-19
* Regularly eat 3 meals/day
* Being willing to avoid alcohol the day before and during test days
* Have a body mass index greater than 18.0 kg/meters squared
* Being willing to refrain from eating after 10 pm the evening before test sessions

Exclusion Criteria:

* Being a smoker
* Being an athlete in training
* Being pregnant or breastfeeding at the time of screening
* Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Dislike or inability to eat the test foods
* Currently dieting to gain or lose weight
* Have a health condition that affects appetite
* Have participated in a similar study in our lab in the past year
* Being a student, faculty, or staff member in nutritional sciences or psychology
Macular Function After Scleral Buckle

Assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e. recovery of structural integrity 3. Assess if there is a difference between macula function postoperatively, in eyes with retinal detachments involving the macula and those that do not.

Patients with acute rhegmatogenous retinal detachments managed by scleral buckling surgery will be recruited into 3 groups. (Please see attached appendix A)

We define the area of the macula as the area within the temporal vascular arcades with the horizontal radius defined between the optic disc and the foveal centre.

Group A: Macula not detached Group B: Macula partially detached i.e. detachment stops within the macula Group C: Macula is totally detached

After scleral buckling surgery for the retinal detachment, the patients will be examined at Day 1, week 1, month1, 3 and 6. During these visits, they will be examined clinically, as well as undergo tests - refraction, colour vision (D-15) \& contrast sensitivity testing, OCT and multifocal ERG. (Please see attaced visit schedule).

Eligibility Criteria:
Inclusion Criteria:

* Acute rhegmatogenous retinal detachment undergoing scleral buckling surgery

Exclusion Criteria:

* Only eye patients
* Patients who undergo surgery which require use of intravitreal gases
* Patients who will not be able to cooperate for the mfERG and OCT testing
* Patients with macula hole detachments
* Fellow eye with poor vision resulting in inability to fixate for the mfERG
n-3 Fatty Acid Infusion and Type 2 Diabetes

The purpose of this experimental study is to investigate whether an acute lipid infusion added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2 diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids. Furthermore other effects on intermediary metabolism are tested for.

Evidence indicates that n-3 fatty acids exert several beneficial effects. However, the effects of marine n-3 fatty acids on intermediary metabolism have not been completely elucidated. In a previous study of a high intake of marine n-3 fatty acids during 9 wk we demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat oxidation in subjects with type 2 diabetes. These results question the use of high doses of n-3 supplements in type 2 diabetes. It is not known to what extent such effects in type 2 diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether short term intravenous administration has other effects.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes defined by clinical criteria and by absence of antibodies to glutamic acid decarboxylase.
* HbA1c 5,5 - 8,5 %
* Blood pressure ≤ 170 mm Hg systolic and/or ≤ 105 mm Hg diastolic

Exclusion Criteria:

* insulin treatment
* hypertriglyceridemia (\> 2,1 mmol/l TG)
* proliferative retinopathy, renal insufficiency (Se-Creatinine \> 150 μmol/l)
* alcoholism, congestive heart failure or other serious diseases affecting the possibility of the subject to participate
* supplement with fish oil or marine n-3 fatty acids during the last 6 months before baseline
* Dicumarol treatment
* allergy to soya, fish or egg
* pregnancy or lactation
* smoking
LISA vs INSURE in the Treatment of Respiratory Distress Syndrome in Preterm Infants

To evaluate the efficacy of less invasive surfactant administration（LISA ）technique in the treatment of neonatal respiratory distress syndrome（NRDS） by comparing with the traditional Intubate-Surfactant-Extubate（INSURE） technique.

Background: Neonatal Respiratory distress syndrome (NRDS) is the most common cause of respiratory problems in premature babies. Surfactant administration involved with endotracheal intubation and mechanical ventilation has proven to be a effective treatment, however, it is associated with a risk of barotrauma, volutrauma and bronchopulmonary dysplasia(BPD). In recent years, some studies have demonstrated that prophylactic INSURE did not lead to a higher survival without BPD, and LISA technique is recommended. However there is no multicenter and Large sample research about it. The aim of this multicenter trial is to compare the efficacy between LISA-treated and INSURE-treated premature Preterm babies with respiratory distress syndrome(RDS).

Methods/Design：In this multicenter, randomized, cohort, prospective trial, 200 preterm infants from 18 neonatal intensive care units in AnHui province whose gestational age (GA) less than 32 weeks with a diagnosis of RDS will be randomized to LISA-treated group and INSURE-treated group.

The primary outcomes include rate of intubation,incidence of bronchopulmonary dysplasia(BPD).The secondary outcomes include arterial blood gas analysis,severity of RDS,the incidence of Patent ductus arteriosus(PDA),Pneumothorax,Abdominal Distention,Neonatal Necrotizing Enterocolitis(NEC,\>Stage II), Retinopathy of Prematurity( ROP,≥ Stage II), Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), Periventricular Leukomalacia(PVL) , mortality, days on noninvasive respiratory support,days on supplemental oxygen and days of hospitalization.Other secondary outcomes include scores of Gesell development Scales of infant development at 3 years of corrected age.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) less than 32 weeks
* diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (Progressive dyspnea, nasal flaring and or grunting), chest X-ray findings and need for noninvasive ventilation support(fraction of inspired oxygen\>40％) in 6 hours after birth
* informed parental consent has been obtained

Exclusion Criteria:

* severe RDS have been treated with endotracheal intubation,surfactant and mechanical ventilation
* major congenital malformations or complex congenital heart disease
* Pulmonary hemorrhage
* Cardiopulmonary failure
* septicemia, Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ), and Congenital genetic metabolic disease
* transferred out of the NICUs(neonatal intensive care units) with surgical treatment or other intervention
Hinting Task for Huntington's Disease

Huntington's disease (HD) is an autosomal dominant neurodegenerative disorder, characterized by movement disorders, behavioural disorders and cognitive decline. Especially the behavioural and cognitive symptoms of the disease lead to significant disability and burden for patients as well as caregivers. One of the cognitive domains affected by HD is social cognition. Social cognition is the ability to perceive, interpret and respond correctly to social information. Aspects of social cognition are emotion recognition, perspective taking (Theory of Mind), and emapathy. Social cognition problems can be related to behavioural problems, but to be able to study this relationship, it is important to be able to reliable measure social cognition impairments. There are a few social cognition tests available, but often they are not normd and validated for use in a Dutch neurological population. There is a lack of sensitive, simple, tests for measuring Theory of Mind in patients with HD. A promising test, that already has been proven valid in a psychiatric population, is the Hinting Task. The Hinting Task measures theory of mind through indirect speech, The Hinting task is a social cognition test, where hints are implicitly given in speech, which resembles what patients and caregivers frequently report as difficult in HD. The Hinting Task has already been translated into Dutch and is already being used in clinical parctice, but its sensitivity has not been studied yet in a neurological population. The aim of this study is to assess if the Hinting Task is sensitive in patients with HD and to relate the Hinting Task to other (social) cognitive measures, demographical characteristics and disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Huntington's disease via CAG-repeat length analysis
* Between 18 and 74 years of age
* Dutch speaking

Exclusion Criteria:

* Presence of serious psychiatric disorders or other neurological comorbidities
Effects of Mindfulness and Yoga on Preschool Students' Emotional Regulation, Behavior, and Social Participation

The goal of this clinical trial is to learn if mindfulness and yoga can improve attention, problem-solving, memory, emotional awareness, and impulsivity in preschoolers. The main questions it aims to answer are:

Can a 30-minute, once-a-week mindfulness and yoga program (Calm \& Alert) over seven weeks in preschool classrooms increase emotional regulation during the school day? Can a 30-minute, once-a-week mindfulness and yoga program decrease negative behavioral incidences during the school day? Can a 30-minute, once-a-week mindfulness and yoga program increase prosocial behaviors like caring, sharing, and perspective-taking during the school day? Researchers will compare the effects of students who participated in the mindfulness and yoga program to students in classrooms who did not receive the program. Student participants will be asked to complete a short self-regulation task test before and after the mindfulness program. Teachers will rate the students on their prosocial behavior before and after the mindfulness program and record negative behavioral incidents over the study period.

The current study design is a quasi-experimental pretest post-study design with a control group. Three schools with a total of four preschool classrooms will participate in this study. Overall, the present research study aims to add to the knowledge base of the benefits of mindfulness and yoga in schools for young children. This will include investigating the effect of mindfulness on children's attention, problem-solving, memory, emotional awareness, and impulsivity. For seven weeks, the intervention group will receive the Calm \& Alert mindfulness intervention alongside the rest of their class involving one session per week of about 30 minutes of yoga and mindfulness. The control group will conduct business as usual and receive the yoga and mindfulness intervention after the study concludes. The intervention will be provided by the principal investigator who is a certified mindfulness-informed professional and registered yoga teacher - 200 hours. It is hypothesized that implementing a 30-minute, once-a-week mindfulness program over seven weeks in preschool classrooms will increase emotional regulation, decrease negative behavioral incidents, and increase prosocial behaviors during the school day.

Eligibility Criteria:
Inclusion Criteria:

* are preschoolers with a filled out and returned parental/caregiver consent form who fall within the four to six-year-old age range, stay within a similar developmental age range, and attend five out of the seven sessions.

Exclusion Criteria: preschoolers without a parental/caregiver consent form, above or below the four to six-year age range will not be included in the study because of the higher variation in developmental capabilities, and if they do not attend five out of the seven sessions.

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