louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03976622: Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata
Official title: Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Psoriasis
Alopecia Areata
Atopic Dermatitis
Keywords: Skin inflammation
Cytokines
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 450 patients (300 patients with vitiligo, 50 psoriasis patients, 50 patients with atopic dermatitis, 50 patients with alopecia areata)

Brief summary: It is a study of translational research with mechanistically objectives and including biological samples of patients with chronic inflammatory disorders

Detailed description: This study was a single-center prospective study to collect blood and skin tissue at the time of consultation with a patient with non-segmental vitiligo, psoriasis, atopic dermatitis or alopecia areata, in order to better understand and compare blood and skin immune response in chronic inflammatory skin disorders: psoriasis, alopecia areata, atopic dermatitis and vitiligo.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75 years;
* Patients with non-segmental vitiligo;
* Patients with plaque psoriasis;
* Patients with atopic dermatitis;
* Patients with alopecia areata sclerosis;
* written consent, free, informed and signed by the patient and the investigator (before any examination required by the study);
* Subject affiliated or beneficiary of a social security system.

Exclusion Criteria:

* Patients with segmental vitiligo
* Patients under local treatment (topical corticosteroid-Calcineurin inhibitor) for less than two weeks.
* Patients on therapy, systemic treatments: acitretin, methotrexate, cyclosporine, Apremilast, infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, dupilumab) for less than 4 weeks.
* Pregnant or breastfeeding women
* Patient (e) under guardianship
* Patient (e) Non-affiliated (e) a social protection

Primary outcomes:
measure: Description of the phenotype and function of blood and skin T-cell in chronic inflammatory skin disorders: psoriasis, vitiligo, atopic dermatitis, alopecia areata
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Dermatologie - Hôpital Saint-André
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien SENESCHAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01485822: A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
Official title: A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Open-angle Glaucoma
Keywords: Glaucoma
Travatan
Trabeculectomy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.

Brief summary: The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
* Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
* Requires a trabeculectomy;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pseudoexfoliation or pigment dispersion;
* History of chronic or recurrent severe inflammatory eye disease;
* History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
* Greater than one month but less than two years of exposure to TRAVATAN;
* Pregnant, breast-feeding, not using highly effective birth control;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Melanin Granule Count
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04841122: Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
Official title: Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 8
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to investigate whether supplemental camera observation directly linked to the nurse's phone will improve patient safety for acute medical care patients', who are restless, confused or in risk of development of acute delirium. The setting is an acute medical care ward.

The expected result is a reduced incidence of patients with delirious condition, patients who fall or unintentionally remove intravenous access or catheters. Thus, higher patient safety and more efficient patient trajectories are expected, as well as a reduced need for treatment, care and rehabilitation after discharge.


Eligibility criteria: Inclusion Criteria:

* Patients over 65 years of age with a CAM score of 2 or higher.

Exclusion Criteria:

* paranoia
* severe dementia
* suicidal
* need for permanent guard

Primary outcomes:
measure: Change in Confusion Assessment Score
timeFrame: First measurement at admission and second measurement within 24 hours.
Secondary outcomes:
measure: Number of patient falls
timeFrame: The time the patient is assessed during the observation period.
measure: Discontinuation of accesses
timeFrame: The time the patient is assessed during the observation period.
measure: Number of administrations of sedatives
timeFrame: The time the patient is assessed during the observation period.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universityhospital
Study officials:
References:
Clinical trial NCT00997139: Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment
Official title: Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Carriers of Staphylococcus Aureus
Keywords: healthcare
staphylococcus aureus
nasal
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent
* Must have consented prior to registration for the study

Exclusion Criteria:

* active infection
* concurrent treatment with antibiotics, topical or systemic
* S. aureus decolonization attempt in prior six months
* history of HIV
* chemotherapy or systemic immunosuppressive therapy
* history of neomycin allergy or sensitivity

Primary outcomes:
measure: Carrier Rate for Staphylococcus Aureus
timeFrame: Baseline
measure: MSSA Clearance Rate
timeFrame: 14 days
measure: MRSA Clearance Rate
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern Unviersity
name: Peter Lio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105739: Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children
Official title: Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway Removal
Respiratory Complication
Lead sponsor: Hôpital d'enfants Béchir-Hamza
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 148
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.

Detailed description: Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:

* Awake: the LMA was left in place until the patient fully regained consciousness
* Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.

Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.

Eligibility criteria: Inclusion Criteria:

* Children scheduled for minor surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Occurence of respiratory adverse events
timeFrame: from LMA removal to 20 minutes afterwards
Secondary outcomes:
Other outcomes:
Locations:
city: Bab Saadoun
country: Tunisia
facility: Hôpital d'Enfants Béchir Hamza
state: Tunis
Study officials:
name: Sonia Ben Khalifa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552539: Syphilis Video Tool to Promote Knowledge and Testing in the ED
Official title: Video Tool to Promote Syphilis Knowledge and Testing in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Keywords: syphilis
educational video
knowledge
black
Hispanic
Lead sponsor: Jacobi Medical Center
Sponsor class: OTHER
Collaborators: name: Public Health Solutions
First posted: 2007-11-02
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine whether the "Syphilis and Men" educational video can be a useful tool to increase syphilis knowledge and testing among English and Spanish-speaking urgent care and emergency department patients, regardless of various self-reported characteristics that increase their risk for syphilis infection.

Detailed description: A randomized four-group intervention-control Solomon design was implemented with Group 1 participants receiving a pre-test survey, the educational video intervention, and a post-test survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a post-test survey; and Group 4 the post-test survey. This design was selected to assess the effect of the video in increasing syphilis knowledge while controlling for the influence of the pre-test instrument in potentially sensitizing participants to key facts. A computer-generated randomization list was created and used to assign patients to groups.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-55 years of age were eligible only if they spoke English or Spanish.

Exclusion Criteria:

* Patients were excluded if clinically unstable, unarousable, hearing impaired or visually impaired despite corrected lens.

Primary outcomes:
measure: The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the educational video.
timeFrame: 20 minutes
Secondary outcomes:
measure: A secondary outcome was the decision to be tested for syphilis.
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center
name: Yvette Calderon, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacobi Medical Center
name: John P Sanchez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177839: Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Official title: Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intussusception
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 178
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects \< 24 months of age seen on an in- or out-patient basis with a diagnosis of intussusception during at least a one year period beginning at study start.

Brief summary: This prospective study aims to estimate the incidence of intussusception among children \< 2 years old through hospital-based surveillance in Singapore.


Eligibility criteria: Inclusion Criteria:

* A male or female infant aged \< 24months at the time of diagnosis of intussusception.
* Subject is diagnosed with definite, probable, possible, suspected intussusception during the period of at least one year beginning at study start.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* A male or female infant ≥ 24 months of age at the time of intussusception diagnosis.
* The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.

Primary outcomes:
measure: Occurrence of definite, probable and possible IS cases in children < 5 yrs of age
timeFrame: Average timeframe: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Phua KB, Lee BW, Quak SH, Jacobsen A, Teo H, Vadivelu-Pechai K, Gopala K, Liu Y. Incidence of intussusception in Singaporean children aged less than 2 years: a hospital-based prospective study. BMC Pediatr. 2013 Oct 8;13:161. doi: 10.1186/1471-2431-13-161.
Clinical trial NCT05573139: Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
Official title: Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength: Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Muscle Weakness
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Among them, a national equipment was developed, but its reliability and validation are yet to be confirmed, compared to equipment already used, such as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor® device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165), already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS: A total of 26 recruits of both sexes were selected. Muscle strength was measured by Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors; flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was collected 3 times, and then the average was calculated.

Detailed description: Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.

Eligibility criteria: Inclusion Criteria:

* 20-40 year
* both sex
* Healthy

Exclusion Criteria:

* individual who practiced physical activity,
* cognitive disability
* osteomioarticular diseases in lower limb and/or spine
* rheumatic or cardiorespiratory disease

Primary outcomes:
measure: Muscle strength assessment by hand dynamometer of the hip
timeFrame: 1 day (single assessment)
measure: Muscle strength assessment by hand dynamometer of the knee
timeFrame: 1 day (single assessment)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Claudio Cazarini Júnior
state: São Paulo
Study officials:
References:
Clinical trial NCT03786939: Evaluation of Outcomes of Coronary Artery Bypass Grafting.
Official title: Evaluation of Outcomes of Coronary Artery Bypass Grafting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Artery Bypass Grafting
Keywords: Ischemic Heart Disease
coronary artery bypass grafting
on-pump CABG
off-pump CABG
pump - assisted CABG
myeloperoxidase after CABG
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluation of outcomes of coronary artery bypass grafting.

Detailed description: Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump assisted as well as bimammary coronary artery bypass grafting.

Objective:

To assess myocardial ischemic-reperfusion damage during different kinds of CABG.

To assess complications after during different kinds of CABG.

Eligibility criteria: Inclusion Criteria:

* Ischemic heart disease with indications for coronary artery bypass grafting.

Exclusion Criteria:

* valve disease

Primary outcomes:
measure: Death.
timeFrame: 30 days during in stay.
Secondary outcomes:
measure: Death over 1 year after CABG.
timeFrame: 1 year.
measure: Death over 3 year after CABG.
timeFrame: within 3 years.
measure: Death over 5 year after CABG.
timeFrame: within 5 years.
measure: Acute myocardial infarction after CABG.
timeFrame: within 30 days after CABG
measure: Acute myocardial infarction after CABG.
timeFrame: within 1 year after CABG
measure: Acute myocardial infarction after CABG.
timeFrame: within 3 years after CABG
measure: Acute myocardial infarction after CABG.
timeFrame: within 5 years after CABG
measure: Shunt dysfunction during 30 days after CABG.
timeFrame: within 30 days after CABG
measure: Shunt dysfunction during 1 year after CABG.
timeFrame: within 1 year after CABG
measure: Shunt dysfunction during 3 years after CABG.
timeFrame: within 3 years after CABG
measure: Shunt dysfunction during 5 years after CABG.
timeFrame: within 5 years after CABG
measure: Stroke.
timeFrame: within 30 days after CABG
measure: Renal Dysfunction.
timeFrame: within 30 days after CABG
measure: Atrial fibrillation.
timeFrame: within 30 days after CABG
measure: IABP
timeFrame: within 30 days after CABG
measure: Infection or febrile.
timeFrame: within 30 days after CABG
measure: Residual myocardial ischemia.
timeFrame: within 30 days after CABG
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: First Pavlov State Medical University
Study officials:
affiliation: First State Pavlov Medical University
name: Alexander Nemkov, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02368639: Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Official title: Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Obesity Hypoventilation Syndrome
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.


Eligibility criteria: Inclusion Criteria:

* Aged 18+
* Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy

Exclusion Criteria:

* Recent cardiac or respiratory arrest
* Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
* Coma, decreased level of consciousness or agitation
* Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
* Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.

Primary outcomes:
measure: Apnea hypopnea index (AHI)
timeFrame: 8 hours
measure: Peripheral blood oxygen level (SpO2)
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare Sleep Laboratory
Study officials:
References: