louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04935996: A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
Official title: A Study Pilot About the Contribution of Pleuropulmonary Echography Iin Acute Bronchiolitis Among Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 80
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pleuropulmonary echography remains an almost non-existent tool in routine pediatric practice.

Our study is part of a desire to develop its use in pediatrics, in particular for the diagnosis of acute bacterial pneumonitis associated with acute bronchiolitis among infants.


Eligibility criteria: Inclusion Criteria:

* Infants aged \<= 2 years old
* Medical diagnosis of acute bronchiolitis requiring hospitalization in the pediatric departments of the Besançon University Hospital
* No opposition from the parents for performing the pleuropulmonary echography.

Exclusion Criteria:

* Children aged \> 2 years old
* Infants aged \< 2 years old consultant in pediatric emergencies for acute bronchiolitis without subsequent hospitalization.
* Previous chronic lung disease (including pulmonary bronchodysplasia), unoperated congenital heart disease or neuromuscular disease.

Primary outcomes:
measure: Comparison between PleuroPulmonary Echography [PPE] and pulmonary radiography
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Besançon
name: Julien BEHR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477996: Pain After Intravitreal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: intravitreal therapy
pain scales
gauge
Pain Scores
Visual Analog Scale
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.

Detailed description: Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).

Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.

Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.

Eligibility criteria: Inclusion Criteria:

* vitrearetinal disease including age-related macular degeneration,
* clinical significant macular edema due to diabetic retinopathy or other vascular disorders
* treatment with intravitreal therapy

Exclusion Criteria:

* missing informed consent
* age under 50 years

Primary outcomes:
measure: Visual Analoge Scale
timeFrame: 1 day, after the intravitreal therapy (IVT)
Secondary outcomes:
measure: patients demographic data
timeFrame: 1 day, record of patients data before or after intravitreal therapy (IVT)
measure: Baker scale
timeFrame: 1 day, after the intravitreal therapy (IVT)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25
Study officials:
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Christiane I Falkner-Radler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Susanne Binder, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03268096: Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
Official title: Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Pathologic Processes
Tomography, Optical Coherence
Magnetic Resonance Imaging
Prognosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-31
Enrollment: 182
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had an episode of demyelination at least 10 years ago

Brief summary: Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is essential to guide the therapeutic management. However, it remains partial and concerns above all data collected during the first years of the disease. The evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. We propose to realize a standardized clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after the first clinical manifestation of the disease.

Clinical and paraclinical assessment will consist in the realization of additional MRI sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). Optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. A clinical evaluation will be performed with the Expanded Disability Status Scale (EDSS).

This study aims:

1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability)
2. to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability)
3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)


Eligibility criteria: Inclusion Criteria:

* First episode of demyelination occurred at least 10 years ago
* Hospitalized in the neurology department during this episode
* Insured with a social security scheme
* Having given his consent to participate in the study

Exclusion Criteria:

* Contraindications to 3 Tesla MRI and injection of contrast media
* Benefiting from a legal protection measure
* Pregnant or nursing mother

Primary outcomes:
measure: Disability assessed with EDSS (Expanded Disability Status Scale)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Antoine Guéguen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688896: Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Hyperlipidemia
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 155
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 evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.


Eligibility criteria: Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C less than 1.6 mmol/L (60 mg/dL)
* TG less than 4.5 mmol/L (400 mg/dL)
* LDL more than 4.0 mmol/L (160 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 65 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol

Primary outcomes:
measure: % change from baseline in HDL-C; inhibition of CETP activity
timeFrame: 4-weeks
Secondary outcomes:
measure: % change from baseline in LDL-C and TC/HDL-C
timeFrame: 4-weeks
measure: Plasma concentration of JTT-705
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
Study officials:
References:
Clinical trial NCT01422096: Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Official title: Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hyperandrogenemia
Obesity
Polycystic Ovary Syndrome
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).


Eligibility criteria: Inclusion Criteria:

* overweight (\>85th BMI%) females
* Early to late puberty (expected age range 7-18)
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

* Screening labs outside of age-appropriate normal range
* Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
* Morning Cortisol \<5 g/dL
* 17-hydroxyprogesterone \>295 ng/dL
* History of Cushing's syndrome or adrenal insufficiency
* Pregnant

Primary outcomes:
measure: 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
timeFrame: 4 weeks after leuprolide
Secondary outcomes:
measure: Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
timeFrame: 4 weeks after leuprolide
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Research in Reproduction
state: Virginia
Study officials:
affiliation: University of Virginia
name: Christine M. Burt Solorzano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486096: Femoral Arterial Cannulation
Official title: Femoral Arterial Cannulation in Infants Following Complicated Sternal Re-entry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: cannulation
infant
femoral arterial
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 1
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric children of successful angio-catheter use on 5 kg child

Brief summary: Many children undergoing surgery for congenital heart disease have had prior operations. Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent peripheral cannulation.

Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in cases of complicated sternal re-entry in children and that angio-catheters can be utilized when vessels are too small for standard cannulas.

Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg child.

Detailed description: In children, many of the standard operative sites are either occluded, stenosed, or too small for the smallest manufactured cannulas. In these instances, it may be feasible to utilize angio-catheters for arterial access until central cannulation can be achieved safely. In an in vitro model, we have simulated a cardiopulmonary bypass circuit and arterial cannulation with angio-catheters.

It appears that angio-catheters may be used with acceptable flow hemodynamics for blood vessels too small for standard cannulas.

We have performed this successfully in a 5 kg child.

We have completed the cardiopulmonary bypass model and are ready to submit the hemodynamic data. We would like to submit to a national meeting and hopefully for publication thereafter.

Eligibility criteria: Inclusion Criteria:

* case report of successful angio-catheter use on 5 kg child

Exclusion Criteria:

* that which does not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory Univ. / Children's Healthcare of Atlanta
name: Brian E Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098396: Rasagiline for Gait Treatment
Official title: Rasagiline for the Treatment of Gait Disturbances in Patients With Parkinson´S Disease (PD): an Open Label Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: parkinson disease
gait
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PD

Brief summary: Gait disturbances are very common and are a major cause for losing of independency in patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances in advanced PD is very difficult and in many cases the classical dopaminergic treatment has no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new MAO-B inhibitor who has recently been approved all over the world for the treatment of early and late stages PD has been suggested to have a special effect of gait in patients with advanced PD (LARGO sub-study).


Eligibility criteria: Inclusion Criteria:

* Patients with PD who experience motor response fluctuations and have gait disturbances at ON and OFF (TUaG \>10 secs in ON and 14 secs in OFF) treated with a stable dose of antiparkinsonian medications for the last month. Patients must be able to identify both situations
* Able to walk for 2 minutes at the OFF and ON state
* Non-demented (MMSE= or \> to25)

Exclusion Criteria:

* Severe orthopedic problems
* Orthostatic hypotension on basal visit
* Severe, troublesome ON dyskinesias
* Dementia (MMSE \<25)
* Major depression
* Active psychosis or on anti-psychotic medications
* Patients who are unlikely to complete the full protocol.
* Patients who have tried rasagiline and stopped because of side effects or lack of symptomatic effect
* Treatment with selegiline for the last 2 months
* Any contraindication according SmPC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02217696: Prediction and Intervention in Developmental Dyslexia
Official title: Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dyslexia
Keywords: Electroencephalography (EEG)
Magnetic Resonance Imaging (MRI)
Multimodal Neuroimaging
Development
Prediction
Intervention
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.


Eligibility criteria: Inclusion Criteria for all groups:

* Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) \>=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
* Additional criteria for subgroups:
* Recruitment of preschoolers (aged 5.5-7.5 years):
* Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
* Recruitment of children in first grade (aged 6.5-8.5years):
* Children showing impairments in learning to read (first/second grade).
* Adults (aged 20-40 years):
* Healthy, normal reading

Exclusion Criteria for all groups:

* MRI contraindications
* No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.

Primary outcomes:
measure: Changes in reading and spelling performance
timeFrame: Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months
Secondary outcomes:
measure: Developmental and training induced changes in functional brain activation and brain structure
timeFrame: Participants will be tested after an expected average of 8, 12 and 16 months
measure: Accuracy of prediction on reading performance outcome
timeFrame: Participants will be tested at T1 and on average 8 months later
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Clinics for Child and Adolescent Psychiatry, University of Zurich
Study officials:
affiliation: University Clinics for Child and Adolescent Psychiatry, University of Zurich
name: Silvia Brem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206516: Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).
Official title: Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Adult Attention Deficit Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: ElMindA Ltd
name: Brainsway
name: Ornim Medical Ltd.
First posted: 2014-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.

Detailed description: This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).

Eligibility criteria: Inclusion Criteria:

1. Patients between the ages of 18-65(male and female)
2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
4. Gave informed consent for participation in the study
5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study

Exclusion Criteria:

1. Suffering from other diagnosis on axis 1
2. History of drug or alcohol abuse during the last year
3. Inability to achieve satisfying level of communication with the subject

Primary outcomes:
measure: Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.
timeFrame: 6 weeks
Secondary outcomes:
measure: changes in functional activity after 4 weeks of tDCS treatment during response inhibition
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: TASMC
Study officials:
affiliation: TASMC
name: Talma Hendler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: