louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01594164: Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
Official title: Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Changes in Upper Airway Geometry
Keywords: High Resolution Computed Tomography
Cone Beam Computed Tomography
upper airway
geometry
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this study the changes in upper airway geometry and resistance between images, obtained in upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20 subjects. The upright morphology will be obtained using CBCT scan while the supine upper airway geometry will be determined using a standard High Resolution Computed Tomography (HRCT) scanner.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained.
* Male or female subject aged ≥ 18 years.
* BMI \< 25 kg/m2 (group 1), BMI ≥ 25 kg/m2 and \< 30 kg/m2 (group 2) and BMI ≥ 30 kg/m2 (group 3) at visit 0. BMI calculation should be repeated if the interval visit 0 - visit 1 \> 14 days.
* Female subject of childbearing potential who confirms that a contraception method was used at least two months before visit 1.

Exclusion Criteria:

* Subject is under the age of legal consent.
* Subject who is pregnant or is breast-feeding.
* Subject with a history of surgery of the upper airway.
* Subject with a history of any illness that, in opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.
* Subject is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
* Subject who received any investigational new drug within the last 4 weeks prior to visit 1.
* Subject who has claustrophobia.

Primary outcomes:
measure: Changes in upper airway geometry
timeFrame: At day 1
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: At screening and also at day 1 (if interval screening - day 1 > 14 days)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03457064: Physical Activity With Social Support Adherence Intervention
Official title: Enhancing Physical Activity With a Social Support Adherence Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Status of Older Adults
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 39
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study compares two programs to increase physical activity among sedentary old persons. The first is a provision of a free physical activity program tailored to their abilities. The other combines the same free physical activity with an adherence intervention which focuses on social contact with others in the program and on enhancing self-efficacy.


Eligibility criteria: Inclusion Criteria:

* Sedentary older adults.
* Residents in congregate housing.

Exclusion Criteria:

* Age under 70.
* Not completing an informed consent form.

Primary outcomes:
measure: The change from baseline in the Rapid Assessment of Physical Activity (RAPA).
timeFrame: Baseline and Three Months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cohen-Mansfield J, Sommerstein M. Motivating Inactive Seniors to Participate in Physical Activity: A Pilot RCT. Am J Health Behav. 2019 Jan 1;43(1):195-206. doi: 10.5993/AJHB.43.1.16.
Clinical trial NCT05178264: Transverse Myelitis Related to SARS-CoV-2 Vaccines
Official title: Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Adverse Reaction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients

Brief summary: Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson \& Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed description: Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Eligibility criteria: Inclusion Criteria:

- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,

Exclusion Criteria:

* chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM.
* vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)

Primary outcomes:
measure: TM reportes related to SARS-CoV-2 vaccine
timeFrame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Secondary outcomes:
measure: Description of the latency period since SARS-CoV-2 vaccine exposure.
timeFrame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
measure: Description of the outcomes following TM
timeFrame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
measure: Description of patients who experienced co-reported adverse events
timeFrame: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References:
Clinical trial NCT01538264: Blood Flow MRI for Monitoring Brain Tumors
Official title: Blood Flow MRI for Monitoring of Glioma Angiogenesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Tumors
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be brain tumor patients recruited through the Brain Tumor Center at the Beth Israel Deaconess Medical Center.

Brief summary: The investigators are studying the use of an advanced magnetic resonance imaging (MRI) technique for measuring blood flow into brain tumors. This technique does not use radioactive tracers, and it can provide high quality images that can be obtained in a standard MRI scanner.

Detailed description: Our goals are:

1. To compare the blood flow measured with this technique with measures of tumor blood vessel density in pieces of the tumor surgically removed as a normal part of clinical treatment. This will confirm a relationship between the imaging measurements and the microscopic characteristics of tumors.
2. To compare the blood flow in tumors before therapy with the concentration of choline, an indicator of cell proliferation. This choline concentration can be measured with another MRI technique. This information will demonstrate the relationship between cell proliferation and blood supply and will also determine whether the choline measurement adds additional information that is clinically necessary.
3. To determine the reproducibility of blood flow measurements in tumors. This is necessary to better understand the sensitivity of the technique to changes in flow caused by a treatment or changes in tumor vascularity.
4. To monitor changes in blood flow after initial treatment. Since sometimes tumors can reappear, the repeated measures will help determine how useful this new imaging technique is at detecting such recurring tumors.

Eligibility criteria: Inclusion Criteria:

* diagnosed with or are suspected of having a glioma

Exclusion Criteria:

* contraindications to MRI which may include the following

  1. Pacemaker
  2. MRI incompatible metal implant
  3. Recently implanted vascular clip
  4. History of claustrophobia
  5. Metal fragment within the eye

Subjects who have received nonstandard therapy may be excluded if the therapy might alter tumor blood flow or other imaging characteristic.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David C Alsop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04971564: Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia
Official title: Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. a Case-control Trial Nested in a Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Hypoxia
Ischemic Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at the Rothschild Foundation Hospital within the first 24 hours of an acute neurological symptomatology

Brief summary: The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.


Eligibility criteria: Inclusion Criteria:

- For cases, admitted within the first 36 hours of an acute neurological symptom related to :

* An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,
* A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,
* An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \>4.

OR

* For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.
* Express consent to participate in the study.
* Member or beneficiary of a social security.

Exclusion Criteria:

* Pre-existing functional and/or cognitive disability
* Patient under legal protection.
* Pregnant or breastfeeding woman.
* Patient with secondary haemorrhagic transformation.

Secondary exclusion criteria :

* Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.
* Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).
* TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.

Excluded patients will be replaced.

Primary outcomes:
measure: Biomarker rates at day 0
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References:
Clinical trial NCT04554290: Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy
Official title: Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy: a Monocentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Vasculitis
Keywords: giant cell arteritis
temporal artery biopsy
vasculitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with significant inflammation on temporal artery biospy, with a final diagnosis of giant cell arteritis or an other diagnosis.

Brief summary: Temporal artery biopsy is a useful tool helping to the diagnosis of giant cell arteritis. However, other diagnoses might be associated with abnormal temporal artery biopsy. The purpose of this study is to describe the frequency of giant cell arteritis differential diagnoses with positive temporal artery biopsy.


Eligibility criteria: Inclusion Criteria:

* positive artery biopsy between january 1st 2000 and july 25th 2019

Exclusion Criteria:

* orther vascular biopsy than temporal artery biospy

Primary outcomes:
measure: percentage of giant cell arteritis and differential diagnoses
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy University Hospital
state: Lorraine
Study officials:
References:
citation: Pontille F, Decker P, Gauchotte G, Jaussaud R, Moulinet T. Diagnoses associated with temporal arteritis. Eur J Intern Med. 2023 Nov;117:140-143. doi: 10.1016/j.ejim.2023.08.010. Epub 2023 Aug 14. No abstract available.
Clinical trial NCT01581190: Bananas as an Energy Source During Exercise: a Metabolomics Approach
Official title: Comparison of Bananas and Gatorade on Performance and Exercise-induced Inflammation, Oxidative Stress, and Changes in Immune Function in Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intense Exercise
Keywords: Bananas
Exercise
Metabolomics
Oxidative stress
Inflammation
Immune function
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: Dole Food Company
First posted: 2012-04-20
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling.

Detailed description: Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). Pre-, post-, and 1-h-post-exercise blood samples were analyzed for glucose, granulocyte (GR) and monocyte (MO) phagocytosis (PHAG) and oxidative burst activity, nine cytokines, F2-isoprostanes, ferric reducing ability of plasma (FRAP), and metabolic profiles using gas chromatography-mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Male
* Ages 18-45 years
* Cyclists, road racing experience.
* Willing to avoid the use of supplements, herbs, medications during the study.

Exclusion Criteria:

* Female
* Over the age of 45 years
* No cycling racing experience
* Using supplements and medications during the study

Primary outcomes:
measure: Performance and fuel substrate utilization as measured through metabolomics
timeFrame: Up to 6 months
Secondary outcomes:
measure: Exercise-induced inflammation.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Human Performance Lab, North Carolina Research Campus
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: David C Nieman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06362590: Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03172390: In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
Official title: In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Rupture
Keywords: Ascending aorta aneurysm
Aortic wall shear stress
4D phase contrast Cardiovascular Magnetic Resonance
Aortic dissection
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: DIAGNOSTIC

Brief summary: Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.

Detailed description: Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection. The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
* Informed consent for participation in the study

Exclusion Criteria:

* Contraindication to MRI
* Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.

Primary outcomes:
measure: Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta
timeFrame: From baseline to 1 year
Secondary outcomes:
measure: Aorta parameters associated with change in aorta diameter
timeFrame: From baseline to 1 year
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
state: Loire
Study officials:
References:
Clinical trial NCT02796690: Staphylococcus Aureus Nasal Carriage
Official title: Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Carriage of Staphylococcus Aureus
Keywords: nasal carriage
Staphylococcus aureus
good hygiene practices
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees of a teaching hospital in Lyon-France

Brief summary: The repeated exposition to S. aureus is considered as a determining factor of acquisition of the nasal colonization. The healthcare professionals are regularly in touch with this pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. The results of our previous study carried out during the international congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. On the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. However, sized of the health care population of our study was limited.

The goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. The main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.


Eligibility criteria: Inclusion Criteria:

- Employees with Consent.

Exclusion Criteria:

- Presence of contraindicating medical conditions preventing nasal swabing

Primary outcomes:
measure: Rate of nasal carriage of Staphylococcus aureus (SA) among employees of a teaching hospital in Lyon-France according to professional exposure and compliance with good hygiene practices.
timeFrame: after 2 days
Secondary outcomes:
measure: Prevalence of nasal carriage of Staphylococcus aureus (SA) methicillin susceptible (MSSA) or methicillin resistant (MRSA) among employees of a teaching hospital in Lyon-France.
timeFrame: after 2 days
measure: Presence or not of nasal carriage of Staphylococcus aureus (SA) among employees of a teaching hospital in Lyon-France at particular conditions as long medication intake and overweight.
timeFrame: after 2 days
Other outcomes:
Locations:
city: Bron
country: France
facility: National Reference Center for Staphylococci, 59 boulevard Pinel
Study officials:
affiliation: National Reference Center for Staphylococci
name: François Vandenesch, Pr
role: PRINCIPAL_INVESTIGATOR
References: