louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04275570: Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Official title: Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Abuse in Pregnancy
Keywords: motivational interview
pregnancy
ethanol intake
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: European Union
name: Red Salud Materno Infantil y del Desarrollo
name: University of Barcelona
First posted: 2020-02-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized simple masking controlled trial
Primary purpose: PREVENTION

Brief summary: Ethanol exposure during pregnancy is associated with adverse perinatal outcomes resulting in high healthcare costs. Primary care centers whose attends low risk women will be randomized to apply a motivational intervention program to the mothers.

Detailed description: This is a cluster randomized simple masking controlled trial evaluating the effectiveness of repeated motivational interview (MI) during pregnancy on prevalence of ethanol intake together with offspring´s neurodevelopment.

.

Eligibility criteria: Inclusion Criteria:

* Maternal age at recruitment \> 18 years
* Speak Spanish fluenty
* Women controlling their pregnancy in Baix Llobregat Center and Hospital Sant Joan de Déu, who will attend their delivery in Hospital Sant Joan de Déu and Parc Sanitari Sant Joan de Déu
* Viable singleton non- malformed fetus
* First trimestre of gestation

Exclusion Criteria:

* Multiple gestations
* Perinatal infections
* Fetal anomalies including chromosomal anormalities or structural malformations detected by ultrasound
* Premature rupture of membranes
* Uncontrolled or/and severe maternal chronic disease
* Language barriers
* Imposibility to obtain the sample (hair lenght below nine centimeters)
* Discolored hair
* Refusal to join the study

Primary outcomes:
measure: Prevalence of ethanol intake
timeFrame: Up to 7 days from delivery
Secondary outcomes:
measure: Prenatal neurodevelopment: Corpus Callosum (CC) assesment
timeFrame: Pregnancy (28 and 32 weeks of pregnancy)
measure: Prenatal neurodevelopment: Cortical development assessment
timeFrame: Pregnancy (28 and 32 weeks of pregnancy)
measure: Prenatal neurodevelopment: Cortical development assessment
timeFrame: Pregnancy (28 and 32 weeks of pregnancy)
Other outcomes:
measure: Postnatal development
timeFrame: Postnatal period: At 18 months of age.
Locations:
city: Barcelona
country: Spain
facility: Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
affiliation: Hospital Sant Joan de Deu
name: Paz Ahumada, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT05046470: SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study
Official title: SARS-CoV-2 Transmission in Belgian Primary Schools of the Federation Wallonia - Brussels: An Epidemiological Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SARS-CoV-2 Infection
Keywords: Primary Schools
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University of Liege
name: Université Libre de Bruxelles
First posted: 2021-09-16
Enrollment: 1233
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Belgian primary schools of the Federation Wallonia - Brussels that have organized a full resumption of school activities with the control measures recommended by the government, are eligible for the study.

Twelve schools were chosen by purposive criteria: either high (≥2 classes per grade) or low size of the school, a school within an area with either a high or a low incidence of SARS-CoV-2 during April 2020, the first wave of covid-19 in Belgium, and a school with either a high or a low socioeconomic level (Belgian 20-point-scale ISE idex \>14 or \<6).

Brief summary: The investigators hypothesize that children are less likely to become infected in the school environment, compared to the household or outside the school setting. Primary schools do not play a major role in SARS-CoV-2 spreading. They hypothesize that incidence level in schools is mainly a consequence of community transmission. The incidence level in household and that the secondary attack rate in schools remains at least 5 times lower that the transmission level in households.


Eligibility criteria: Inclusion Criteria:

* All children and school attenders from selected schools was invited to participate

Exclusion Criteria:

* Refusal to provide written informed consent before enrolment

Primary outcomes:
measure: Infection of a child with SARS-CoV-2 secondary to a classmate
timeFrame: 6 weeks
measure: Infection of an adult school-attender with SARS-CoV-2 secondary to an infected child
timeFrame: 6 weeks
measure: Infection of a child with SARS-CoV-2 secondary to an adult school attender
timeFrame: 6 weeks
measure: Infection of a child with SARS-CoV-2 secondary to a contact outside the school, including the household
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UCLouvain
Study officials:
affiliation: Université Catholique de Louvain
name: Annie Robert, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153370: Comparison of Different Video Laryngoscopes in Infants Undergoing Neurosurgery: a Prospective Randomized Clinical Trial
Official title: Comparison of Airtraq, Glidescope and C-mac in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Conditions
Keywords: airtraq
glidescope
c-mac
videolaryngoscope
intubation
infant
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 60
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of \<1 year old children undergoing neurosurgery.

Detailed description: Aim: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

Methods: We enroll 20 patients age under 1 year old undergoing neurosurgery in this prospective randomized study. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of \<1 year old children undergoing neurosurgery regarding intubation times and intubation success rates.

Eligibility criteria: Inclusion Criteria:,

* 0-1 age
* undergoing neurosurgery
* ASA 1-2

Exclusion Criteria:

* cardiac problems
* ASA 3-4
* emergency

Primary outcomes:
measure: intubation time
timeFrame: 40 seconds
Secondary outcomes:
measure: insertion time
timeFrame: 20 seconds
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
References:
Clinical trial NCT05068570: Effect of Arm Ergometry on Children With Down Syndrome
Official title: The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EFFECT OF ARM ERGOMETRY ON RESPIRATION
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.

Detailed description: 30 Down's syndrome children (boys and girls). randomly separated into two groups of equal size. Both groups received traditional chest physical therapy, with the addition of arm ergometry training in Group B

Eligibility criteria: Inclusion Criteria:

* comprehend and follow directions
* AGE 10-14

Exclusion Criteria:

Anomalies of the vasculature.

-Participating in sports of any kind. Moderate to severe asthma

Primary outcomes:
measure: Discovery Spirometer
timeFrame: pre and post treatment for 14 weeks at 3 times per week.
measure: Discovery spirometer
timeFrame: Pre and post treatment for 14 weeks at 3 times per week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa
Study officials:
References:
Clinical trial NCT01540370: Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with open-angle glaucoma and/or ocular hypertension

Brief summary: This study will evaluate assessments from the Goniometric Lens compared with those from anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular hypertension (OHT).


Eligibility criteria: Inclusion Criteria:

* Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Allergy or sensitivity to diagnostic agents used in study

Primary outcomes:
measure: Intra- Examiner Agreement in Angle Width by Goniometric Lens
timeFrame: Day 1
measure: Inter- Examiner Agreement in Angle Width by Goniometric Lens
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
state: New York
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02038270: Accuracy of Nexfin® and NIBP to Predict IBP
Official title: Evolution of the Accuracy of the Nexfin Pressure Signal Compared to Invasive and Noninvasive Arterial Blood Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodpressure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 Adult patients, that are having a routine surgical procedure.

Brief summary: The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP).

Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.

Detailed description: In patients under stable anesthesia conditions, who have IBP and NIBP monitoring, the Nexfin will additionaly be connected. All data will be recorded for at least 30 minutes. NIBP will be measured every 5 minutes The evolution of the NIBP, IBP and Nexfin-derived blood pressure will be analysed to determine the evolution of inaccuracy due to incomplete vascular unloading and to determine the accuracy of Nexfin compared with NIBP to determine IBP.

Eligibility criteria: Inclusion Criteria:

* Patients that are accepted for surgery

Exclusion Criteria:

* Patients unable or unwilling to provide consent.

Primary outcomes:
measure: vascular unloading time
timeFrame: Start till end of operation
Secondary outcomes:
measure: Bloodpressure
timeFrame: Start till end of operation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: univertsity medical center groningen,university of groningen,the netherlands
name: Alain Kalmar, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03400670: Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome
Official title: Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilatory Failure
Keywords: NCPAP
Respiratory Distress Syndrome
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Detailed description: Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 \<0.30.

Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.

Non-invasive respiratory support failure is set as follows:

* FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
* Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
* Persistent acidosis; presence of pH \< 7.20 and PCO2 \> 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
* Severe respiratory distress,
* Pulmonary haemorrhage and cardiopulmonary arrest.

Eligibility criteria: Inclusion Criteria:

* Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

Exclusion Criteria:

* Major congenital anomalies
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused

Primary outcomes:
measure: noninvasive ventilation failure
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Suna Oğuz
role: STUDY_DIRECTOR
References:
Clinical trial NCT02061670: Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Asthma
Keywords: Ragweed
Allergy
rhinoconjunctivitis
rhinitis
asthma
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2014-02-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years.
* Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
* A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons.
* Positive skin prick test to ragweed
* Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.

Exclusion Criteria:

* History of life-threatening asthma.
* Uncontrolled asthma according to GINA
* FEV1 of \< 70 % of predicted, regardless of the cause.
* Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* History of severe drug allergy or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 22 weeks
Secondary outcomes:
measure: Number of subjects with asthma exacerbations as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 22 weeks
measure: Evaluation of change in lung function as a measure of safety and tolerability
timeFrame: Throughout subjects participation in the study, approximately 22 weeks
Other outcomes:
Locations:
city: Kanata
country: Canada
facility: Kanata Allergy Services
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Cheema Research Inc
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Inflamax Research
state: Ontario
Study officials:
References:
Clinical trial NCT01903070: Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment
Official title: EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a bi-centric, prospective, open study comparing the effects of linagliptin on active GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification

Exclusion Criteria:

* Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis.

Primary outcomes:
measure: ΔAUCGLP-1-OGTT(0-240)
timeFrame: Glucose tolerance test following 7 days of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: NRW
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Christoph Kapitza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745470: Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain
Official title: Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: lean/obese diabetes mellitus
functional MRI
GLP-1
appetite
activation of brain
connectivity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2016-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes

Detailed description: Fifteen lean \[BMI(body mass index) less than 23 kg/m2\] type 2 diabetes subjects and fifteen obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be recruited. Every subject will be studied on 2 separate days in random order with 1-2 week intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet will be provided to every participant and the intake will be measured. Surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.

Eligibility criteria: Inclusion Criteria:

* BMI ≤ 23kg/m2 or BMI ≥ 26kg/m2
* participants with diabetes treated by diet or oral antidiabetic drug, HbA1c less than 8.5%

Exclusion Criteria:

* Those who diagnosed by Type 1 diabetes
* History of insulin therapy
* Aspartate aminotransferase(AST) or Alanine transaminase(ALT) \>2.5 times of upper normal reference range
* Estimated Glomerular Filtration Rate(eGFR) \<30 mL/min/1.73m2
* Those who can't be performed MRI

Primary outcomes:
measure: Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus
timeFrame: 10min (40 min after injection)
measure: Whole brain connectivity
timeFrame: 20min (50 min after injection)
Secondary outcomes:
measure: appetite change
timeFrame: -30min, 45min(after fMRI), 70min(after buffet)
measure: mood change
timeFrame: -30min, 45min(after fMRI), 70min(after buffet)
measure: intake of food in the buffet
timeFrame: 50min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine
name: Young Min Cho, MD, PHD
role: STUDY_CHAIR
References: