louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05137379: Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)
Official title: Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ehlers-Danlos Syndrome
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-30
Enrollment: 200
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: Patient over 18 years-old, suffering from Ehler-Danlos syndrome treated with surgery

Brief summary: The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years-old suffering from Ehlers-Danlos Syndrome and belonging to the EDS cohort of Raymond Poincaré Hospital in Garches
* Patient with joint involvement of the shoulder treated by surgery
* Patient with ankle joint damage treated by surgery
* Patient with joint damage to the knee treated by surgery
* Patient with elbow joint damage treated by surgery
* Patient with joint involvement of the wrist treated by surgery
* Patient affiliated or beneficiary of a social security scheme
* Patient who has been informed of the research and does not object to the use of his data.

Exclusion Criteria:

* Patient objecting to the use of their data

Primary outcomes:
measure: Joint function score according to the affected joint
timeFrame: 1 day
measure: Joint function score according to the affected joint
timeFrame: 1 day
measure: Joint function score according to the affected joint
timeFrame: 1 day
measure: Joint function score according to the affected joint
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
state: Ile De France
city: Paris
country: France
facility: Clinique Maussins-Nollet
Study officials:
References:
Clinical trial NCT06954779: Arginine Plaque Metabolism Pilot Clinical Study
Official title: Arginine Plaque Metabolism Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque, Dental
Keywords: saliva
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the nine-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Good general health

Exclusion Criteria:

* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate care.
* Concurrent participation in any other oral care clinical study or test panel.
* Self-reported pregnant or lactating women.
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of tobacco use-smoking, vaping and chewing tobacco
* Presence of orthodontic bands, presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study
* Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc

Primary outcomes:
measure: Plaque collection
timeFrame: baseline, week 3, week 4, week 6, week 7, week 8, week 9
Secondary outcomes:
measure: Saliva collection
timeFrame: week 5 and week 9
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Volpe Clinical Center
state: New Jersey
Study officials:
References:
Clinical trial NCT06170879: What is the Experience of the Professional Nurse Advocates (PNAs) Application of the A-EQUIP Model Into Practice
Official title: What is the Experience of the Professional Nurse Advocates (PNAs) Application of the A-EQUIP Model Into Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staff Attitude
Professional Role
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional nurse advocates working in the Midlands

Brief summary: The study will utilise focus groups with trained PNAs from different Trusts spread over the Midlands region within England. This approach will help explore the experiences and views of trained PNAs in the application of the role and the foundations on which it is supported. It will also supply valuable feedback regarding the preparation, implementation, and outcome of adopting the PNA position with health care organisations, as there is a suggestion that the role could expand from England to the United Kingdom and possibly the United States of America.


Eligibility criteria: Inclusion Criteria:

• Qualified Professional Nurse Advocate (PNAs) all of whom would have successfully completed a PNA level 7 module provided by a Higher Education Institution within England

Exclusion Criteria:

• Any qualified nurse who has not successfully completed a PNA module.

Primary outcomes:
measure: To measure the experiences of PNAs in implementing the role within their clinical practice and using the A-EQUIP model
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References:
Clinical trial NCT02971579: A Register on the Quality of ERCP and Training of Endoscopists in Italy
Official title: A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Diseases
Pancreatic Diseases
Keywords: ERCP
biliary diseases
Pancreatic diseases
outcome
Quality
Training
Lead sponsor: ASST Rhodense
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive adult patients undergoing ERCP for various indications

Brief summary: This is a prospective observational longitudinal study

Aim of the study is to collect information:

* on the organization models of the Endoscopic Units performing ERCP in Italy
* on the previous and/or ongoing training of the endoscopists performing ERCP
* on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome

Detailed description: Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series.

Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure

The study consists of 3 phases:

1. Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
2. Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
3. Definition of the the outcome of ERCP assessed after 30 days from the procedure

Eligibility criteria: Inclusion Criteria:

* Willingness to participate in the study

Exclusion Criteria:

* Informed consent not subscribed

Primary outcomes:
measure: Complications rate
timeFrame: 30 days
Secondary outcomes:
measure: Rate of repeated procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Novara
country: Italy
facility: AOU Maggiore della Carità
Study officials:
affiliation: AOU Maggiore della Carità Novara
name: Pietro Occhipinti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02755779: Characterization of Breast Masses Incidentally Detected on Chest CT
Official title: Characterization of Breast Masses Incidentally Detected on Chest CT - a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Tel Aviv Medical Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman over 18

Brief summary: Although Computed tomography (CT) is not routinely used to evaluate beast masses, It is common to discover Incidental breast lesions on chest CT.

The goal of this study is to investigate the incidence and appearance of incidentally discovered breast masses on chest CT.


Eligibility criteria: Inclusion Criteria:

* Woman with incidentally discovered breast masses on chest CT

Exclusion Criteria:

* Male gender
* Known breast cancer

Primary outcomes:
measure: Patient enrollment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sourasky medical center Tel aviv
name: Yoav Amitai, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524079: Right Ventricle Morphology and Hemodynamics in BrS
Official title: Morphological and Functional Characteristics of the Right Ventricle in Patients With Brugada Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brugada Syndrome
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 60 selected subjects (30 BrS patients and 30 normal controls) will be enrolled.

Brief summary: The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.

Detailed description: All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.

Eligibility criteria: Inclusion Criteria:

* Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
* Indication to ajmaline testing and programmed ventricular stimulation
* Age \> or equal to 18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Contraindication to CMRI or to ajmaline
* Live espectance \< 12 months

Primary outcomes:
measure: Electrocardiographic changes
timeFrame: 1 day during Electrocardiography
measure: MRI changes of left and right ventricular function
timeFrame: 1day during MRI
measure: CMR parameters changes of the right and left ventricle function
timeFrame: 1 day during CMR
measure: Electrical substrate changes of the right ventricle
timeFrame: 1 day after ICD implantation
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S. Donato
state: Milano
Study officials:
affiliation: IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pappone C, Santinelli V, Mecarocci V, Tondi L, Ciconte G, Manguso F, Sturla F, Vicedomini G, Micaglio E, Anastasia L, Pica S, Camporeale A, Lombardi M. Brugada Syndrome: New Insights From Cardiac Magnetic Resonance and Electroanatomical Imaging. Circ Arrhythm Electrophysiol. 2021 Nov;14(11):e010004. doi: 10.1161/CIRCEP.121.010004. Epub 2021 Oct 25.
Clinical trial NCT02564679: Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD
Official title: Effects of Sleeve Gastrectomy on Hepatic and Metabolic Abnormalities in Adolescents With Complicated Morbid Obesity and NAFLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
NAFLD
Keywords: bariatric surgery
sleeve gastrectomy
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pediatric obesity has become a critical health problem worldwide, increasing the premature onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence of serious health complications starting in childhood and adolescence. Lifestyle interventions, including diet and regular physical activity, are the cornerstone of current medical management. Unfortunately, these interventions are often ineffective in providing a meaningful and long-lasting weight loss necessary to change health outcomes. It has been demonstrated that an early intervention in obesity in children and adolescents, inducing weight loss by performing bariatric surgery in carefully selected patients, can dramatically reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic fatty liver disease (NAFLD).

Recent evidence suggest that bariatric surgery can improve metabolic complications and liver involvement in patients affected by morbid obesity.


Eligibility criteria: Inclusion criteria:

* BMI\>40 kg/m2 with severe comorbidities
* Type 2 diabetes mellitus
* Moderate-to-severe sleep apnea
* Pseudotumor cerebri
* NASH with advanced fibrosis (ISHAK score\>1)
* BMI\>50 kg/m2 with mild comorbidities
* Hypertension
* Dyslipidemia
* Mild obstructive sleep apnea
* Chronic venous insufficiency
* Panniculitis
* Urinary incontinence
* Impairment in activities of daily living
* NASH
* Gastroesophageal reflux disease
* Severe psychological distress
* Arthropathies related to weight

Exclusion Criteria:

* Documented substance abuse problem
* Medically correctable cause of obesity
* Disability that would impair adherence to postoperative treatment, present pregnancy, or breast-feeding

The patients included in the present study were enrolled according to the recent indications for bariatric surgery in severly obese adolescents of Hepatology Committee of European Society of Pediatric Gastroenterology, Hepatology And Nutrition (ESPGHAN) (JPGN 2015;60: 550-561)

Primary outcomes:
measure: Improvement of metabolic parameters
timeFrame: 12 months
measure: Improvement of liver parameters
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of liver histology
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03587779: Comparison of Effect of Equi-MAC Anesthetics on PSI
Official title: Comparison of the Effect of Sevoflurane and Desflurane on Patient State Index: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: patient state index
sevoflurane
desflurane
minimum alveolar concentration
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.

Detailed description: There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients aged between 19 and 65 yr
* patients with American Society of Anesthesiologists physical status classification I or II
* patients scheduled for elective surgery under volatile anesthesia
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients receiving any medication affecting the autonomic or central nervous system
* patients with a history of alcohol or drug abuse
* pregnant or lactating women

Primary outcomes:
measure: patient state index
timeFrame: After a 30-min waiting period from the induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoung-Ho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217879: COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-i Treatment Due to couGH in Slovakia
Official title: Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Cough
Telmisartan
Bradykinin
Tolerability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic hypertensive patients with cough caused by the ACE-I regardless any other factors.

Brief summary: In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.


Eligibility criteria: Inclusion Criteria:

* Hypertension
* Age \> 18
* ACE-I related cough

Exclusion Criteria:

* Current treatment with telmisartan
* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period

Primary outcomes:
measure: Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough
timeFrame: 4 months after initiation
Secondary outcomes:
measure: Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough
timeFrame: 4 months after initiation
Other outcomes:
Locations:
city: Many Locations
country: Slovakia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02316379: Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
Official title: Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Respiratory Disorders
Keywords: Respiratory
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of adults for the purposes of obtaining optimal images through MRI.

Detailed description: Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center. Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses for up to four MRI scans. Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans. In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected. Follow up will be done one day and 30 days from the MRI date.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18 years and older
* Participant must be able to hold their breath for up to 16 seconds

Exclusion Criteria:

* History of heart defect
* Pregnancy or positive pregnancy test
* History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month.
* Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week.
* Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
* Participant is claustrophobic and unable to tolerate the imaging.
* Standard MRI exclusions (metal, implants).

Primary outcomes:
measure: Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jason C Woods, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: