louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05624255: Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score
Official title: Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Abnormalities
Vascular Diseases
Retinal Vascular
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 101
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Recent case-control studies have proven that the retinal vascularization mirrors the cardiac vascularization: more the coronary network is altered, more the density of retinal vessels is reduced. No studies have yet been realised in primary prevention. This study aims to demonstrate a link between the density of the retinal vascularization and the calcium score, which is currently the gold standard for the classification of cardiovascular risk in primary prevention. Thus, a simple image of the retinal vascularization could predict the cardiovascular risk of a patient. OCT angiography would become a major aid in the classification of cardiovascular risk in asymptomatic patients.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Correlation between retinal vascular density and calcium score
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT00658255: Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler
Official title: A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Asthma
Keywords: stable asthma
adults
formoterol
Symbicort
Oxis Turbuhaler
bronchodilation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of asthma and baseline lung function tests as determined by the protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Primary outcomes:
measure: Average FEV1 during 12 hours
timeFrame: Once a week for 5 weeks during treatment period
Secondary outcomes:
measure: Urine levels of formoterol in 2 different formulations
timeFrame: Once a week (12 hour urine collection) for 5 weeks during treatment period
measure: Safety profiles of formoterol in 2 different formulations
timeFrame: Once a week for 5 weeks during treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Pharmaceutical Research & Consulting Inc
name: Michael E Ruff, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_CHAIR
References:
Clinical trial NCT02773355: Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
Official title: Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-05-16
Enrollment: 27
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: The medical condition investigated in this study is obesity and overweight with one or more weight related comorbidities. The study will aim at observing all patients exposed to Saxenda® during treatment by the 20 participating physicians in Mexico.

Brief summary: This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.


Eligibility criteria: Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate the treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Obese patients (BMI equal to or above 30 kg/m\^2) or overweight patients (BMI Equal to or above 27 kg/m\^2) with at least one weight related comorbidity according to Saxenda® label text in Mexico
* Age equal or above 18 years at the time of signing informed consent

Exclusion Criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Hypersensitivity to Saxenda® or to any of its excipients
* Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Diagnosis of type 1 diabetes

Primary outcomes:
measure: Frequency of pancreatitis
timeFrame: Year 0-3
Secondary outcomes:
measure: Adverse drug reactions (ADR)
timeFrame: Year 0-3
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Novo Nordisk Investigational Site
state: Estado De México
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: Puebla
country: Mexico
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03241355: Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
Official title: Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Children, Only
Diet Modification
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 258
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy at the time of pre-examination
* Subject is aged 3-6 years at the time of pre-examination
* Subject attends a kindergarten at the time of pre-examination

Exclusion Criteria:

* congenital disease or malformation influencing the gastrointestinal System
* children with congenital or acquired immunodeficiency
* children with food intolerance, food allergy or metabolic disorder requiring special diet
* children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
* children who consumed antibiotics or laxatives within 14 days
* children who had any infectious disease within 14 days at the time of pre-examination

Primary outcomes:
measure: Frequency of infectious disease episodes
timeFrame: 24 weeks period
Secondary outcomes:
measure: microbiota composition
timeFrame: 24 weeks period
Other outcomes:
Locations:
Study officials:
affiliation: Department of Paediatrics, University of Pécs, Hungary
name: Tamás Decsi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lohner S, Kullenberg D, Antes G, Decsi T, Meerpohl JJ. Prebiotics in healthy infants and children for prevention of acute infectious diseases: a systematic review and meta-analysis. Nutr Rev. 2014 Aug;72(8):523-31. doi: 10.1111/nure.12117. Epub 2014 Jun 5.
citation: Lohner S, Jakobik V, Mihalyi K, Soldi S, Vasileiadis S, Theis S, Sailer M, Sieland C, Berenyi K, Boehm G, Decsi T. Inulin-Type Fructan Supplementation of 3- to 6-Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. J Nutr. 2018 Aug 1;148(8):1300-1308. doi: 10.1093/jn/nxy120.
citation: Soldi S, Vasileiadis S, Lohner S, Uggeri F, Puglisi E, Molinari P, Donner E, Sieland C, Decsi T, Sailer M, Theis S. Prebiotic supplementation over a cold season and during antibiotic treatment specifically modulates the gut microbiota composition of 3-6 year-old children. Benef Microbes. 2019 Apr 19;10(3):253-263. doi: 10.3920/BM2018.0116. Epub 2019 Feb 19.
Clinical trial NCT02207855: Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 21
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and infants who have received chloroprocaine for epidural anesthesia.

Brief summary: This a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.


Eligibility criteria: Inclusion Criteria:

* Neonates and infants who have received chloroprocaine for epidural anesthesia.

Exclusion Criteria:

* None

Primary outcomes:
measure: Pain score
timeFrame: Every 6 hours for 72 hours
Secondary outcomes:
measure: Pain medicine consumption
timeFrame: Every 6 hours for 72 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929355: Carotid Atherosclerosis and Vascular Events in People With Diabetes
Official title: Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Atherosclerosis
Keywords: Carotid atherosclerosis
duplex ultrasonography
diabetes
vascular events
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 731
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 diabetes and a carotid assessment by duplex ultrasonography in 2012 in a monocentric diabetic unit

Brief summary: Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.


Eligibility criteria: Inclusion Criteria:

* Age \>18 ans
* Diabetes
* Carotid duplex ultrasonography in 2012

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of vascular events between day one and the last day of follow-up reviewed by patient examination
timeFrame: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography (between 01/2014 and 09/2016)
Secondary outcomes:
measure: Rate of carotid atherosclerosis progression measured by duplex ultrasonography in percentage of stenosis
timeFrame: Day of the last assessment of carotid atherosclerosis by duplex ultrasonography between 01/2014 and 09/2016.
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon
Study officials:
References:
citation: Vouillarmet J, Marsot C, Maucort-Boulch D, Riche B, Helfre M, Grange C. Vascular Events and Carotid Atherosclerosis: A 5-Year Prospective Cohort Study in Patients with Type 2 Diabetes and a Contemporary Cardiovascular Prevention Treatment. J Diabetes Res. 2019 Dec 22;2019:9059761. doi: 10.1155/2019/9059761. eCollection 2019.
Clinical trial NCT00542555: Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Official title: 301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 918
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Detailed description: This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Eligibility criteria: Inclusion Criteria:

* Men and women (40 or older) with a diagnosis of primary OA of the knee
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at screening

Exclusion Criteria:

* Uncontrolled hypertension or diabetes
* Hepatic or renal impairment
* Current or expected use of anticoagulant
* A history of alcohol or drug abuse
* Candidates for imminent joint replacement
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
* Current medical disease that could confound or interfere with the evaluation of efficacy
* Participation within 30 days prior to screening in another investigational study

Primary outcomes:
measure: The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data
timeFrame: 13 weeks / long term
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schnitzer TJ, Kivitz A, Frayssinet H, Duquesroix B. Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study. Osteoarthritis Cartilage. 2010 May;18(5):629-39. doi: 10.1016/j.joca.2009.12.013. Epub 2010 Feb 16.
Clinical trial NCT02722655: Cohort of Mexican Children With Diabetes Mellitus (CMC-DM)
Official title: Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: Pediatrics
Lead sponsor: Hospital Regional de Alta Especialidad del Bajio
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents (boys and girls) from 1 months to 17 years of age that had recently been diagnosed with diabetes mellitus.

Brief summary: The aim of this study is the identification of complications in diabetes mellitus pediatric patients and to compare the clinical, anthropometric, and biochemical characteristics between children in the different types of diabetes mellitus.

Detailed description: Diabetes mellitus is characterized by hyperglycemia resulting from defects in insulin secretion and/or insulin resistance in target tissues. This study identify the influence of pathogenic factors on the evolution of diabetes mellitus and in the presence of chronic complications.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of diabetes mellitus

Exclusion Criteria:

-

Primary outcomes:
measure: Diabetic retinopathy
timeFrame: year 3
measure: Peripheral diabetic neuropathy
timeFrame: year 5
measure: Nerve damage
timeFrame: year 5
measure: Microalbuminuria
timeFrame: annual
measure: Cardiac function
timeFrame: year 5
measure: Cognitive evaluation
timeFrame: year 3
measure: Intelligence quotient evaluation
timeFrame: year 3
Secondary outcomes:
measure: Body composition
timeFrame: annual
measure: Glycemic control
timeFrame: annual
measure: Beta cell function
timeFrame: annual
measure: Pancreatic autoimmunity
timeFrame: onset of diabetes
measure: Insulin resistance
timeFrame: annual
measure: Alpha cell function
timeFrame: year 5
measure: Hyperlipidemia
timeFrame: annual
measure: Hypothyroidism
timeFrame: annual
measure: Hypertension
timeFrame: annual
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Hospital Regional de Alta Especialidad del Bajío
state: Guanajuato
Study officials:
affiliation: Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío
name: María L Evia-Viscarra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evia-Viscarra ML, Guardado-Mendoza R, Rodea-Montero ER. Clinical and Metabolic Characteristics among Mexican Children with Different Types of Diabetes Mellitus. PLoS One. 2016 Dec 16;11(12):e0168377. doi: 10.1371/journal.pone.0168377. eCollection 2016.
Clinical trial NCT05933655: Re-thinking the Role of Peers And Training Patients [RePeAT]
Official title: Re-thinking the Role of Peers And Training Patients [RePeAT]
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: . Patients will be randomized at a 1:1 ratio, stratified by the clinician.
Primary purpose: PREVENTION

Brief summary: This study, Re-thinking the role of Peers And Training Patients \[RePeAT\], is designed to test the feasibility of training peer-coaches to prepare limited health literacy (LHL) patients to engage in shared-decision making (SDM) for cardiovascular disease (CVD) risk-reduction.

Detailed description: The investigators will use a 2-arm pilot RCT design to assess the feasibility, and acceptability of the intervention. Up to 60 primary care patients will be randomly assigned to participate in the peer-coaching or control group. Patients will be randomized at a 1:1 ratio, stratified by the clinician. Half of the subjects (n=30) will be assigned to the peer-coaching intervention, and the other half will be assigned to the control group.

Eligibility criteria: Inclusion Criteria:

* A patient of Highland Family Medicine practice
* At least 40 years old and no more than 75 years old
* Be at ≥10% risk for CVD as calculated using the ASCVD Risk Estimator Plus
* No plans to leave the practice in the next 12 months
* English speaking
* Limited Health Literacy (self-report)

Exclusion Criteria:

* Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) or have had a CVD procedure such as installation of a stent or angioplasty
* Gave peripheral vascular disease, intermittent claudication or peripheral arterial disease
* Lack of capacity to consent

Primary outcomes:
measure: ABCS Discussion
timeFrame: patient-clinician office visit, approximately 1 week after the peer coaching session
Secondary outcomes:
measure: Peer Coach Fidelity
timeFrame: post-coaching, approximately 1-2 weeks prior to the patient-clinician office visit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: