louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02939001: Evaluating the Effect of Laser Vision Surgery, Phakic Intraocular Lens Implantation, Cataract Surgery, and Pupil Dilation on the Iris Recognition Scanner Function of Smartphone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Myopia
Myopic Astigmatism
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study included patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined whether iris recognition scanner of smartphone works before and after surgery. In addition, before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris recognition scanner of smartphone works well.


Eligibility criteria: Inclusion Criteria:

* Patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction)
* phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex)
* cataract surgery.
* age of 20\~90

Exclusion Criteria:

* history of previous ocular or intraocular surgery
* glaucoma or ocular hypertension, ocular infection, non-dry eye ocular inflammation, ocular allergy, autoimmune disease
* history of iris damage during ocular surgery or previous trauma
* wearing contact lenses during the study period
* presence of current punctal occlusion
* pregnancy, lactating women, and children

Primary outcomes:
measure: capability of iris recognition scanner
timeFrame: 1 day before the surgery
measure: capability of iris recognition scanner
timeFrame: 1 week after the surgery
Secondary outcomes:
measure: pupil dilation
timeFrame: 1 day before pupil dilation
measure: pupil dilation
timeFrame: 1 week after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04367701: Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major
Official title: Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major : Analysis of Hemolysis During Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemolysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with thalassemia major undergoing surgical repair for congenital heart disease

Brief summary: Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group


Eligibility criteria: Inclusion Criteria:

* Pediatric Patients with thalassemia major.
* Pediatric Patients with congenital heart disease undergoing surgical repair.

Exclusion Criteria:

* known hepatic or renal disease
* uncontrolled active hemolytic reaction
* emergency surgery
* redo surgery

Primary outcomes:
measure: Hemolysis
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Galal Mo El kadi, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04788901: Assessment of Emotion-regulation Skills in Game-based Situations
Official title: The Validity of In-game Performance Measurements or Scores as Indicators of Children's Emotional Regulation Abilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Keywords: emotional regulation
online therapeutic game
emotional regulation assessment
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2021-03-09
Enrollment: 110
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.


Eligibility criteria: Inclusion Criteria:

* children and adolescents between 10 and 14 years
* provided written parental consent

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder

Primary outcomes:
measure: Emotion-regulation
timeFrame: Pre-intervention (one day before the intervention)
measure: Strengths and difficulties
timeFrame: Pre-intervention (one day before the intervention)
measure: Emotional symptoms
timeFrame: Pre-intervention (one day before the intervention)
measure: Emotion recognition
timeFrame: Pre-intervention (one day before the intervention)
measure: Compassion
timeFrame: Pre-intervention (one day before the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
References:
Clinical trial NCT05689801: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
Official title: Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Terminal Renal Insufficiency
Keywords: terminal renal insufficiency
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described.

More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. The recovery time and quality of life of patients who will use a polyethersulfone membrane (Revaclear®) and a Medium Cut-Off (MCO) membrane (Theranova®) will be observed.

The main objective is to describe the evolution of recovery time after a dialysis session in conventional hemodialysis (HD) on Revaclear® membrane and in so-called optimized hemodialysis (HDx) on MCO membrane, Theranova®.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age
* Patient on conventional hemodialysis with synthetic membrane for at least 3 months
* Patient with a recovery time after the dialysis session ≥ 4 hours
* Informed patient who has signed a written consent to participate in the study
* Affiliated patient or beneficiary of a social security scheme

Exclusion Criteria:

* Patient whose seniority of dialysis is less than 3 months
* Pregnant woman
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient with severe cognitive impairment
* Medically unstable or frail patient
* Patient who did not sign an informed consent form accepting this research (refusal of consent or absence of signature).

Primary outcomes:
measure: Result of the questionnaire "recovery time after a dialysis session"
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT04137601: Congenital Syphilis Prospective Cohort With Retrospective Evaluation
Official title: Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis, Congenital
Keywords: Congenital syphilis
VDRL
CSF
Clinical manifestations
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 62
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In older children, the sexual route for abuse will be ruled out as a means of interrogation infection and analysis of family dynamics by a multidisciplinary team.

Brief summary: Syphilis is an infectious disease caused by Treponema pallidum. In children, there are two different forms of this disease; acquired syphilis and congenital syphilis, which results from transplacental transmission of spirochetes.

The worldwide incidence of congenital syphilis has increased in past years, probably due to inadequate control of pregnant women and lack of early diagnose and treatment in acute infected adults.

This infection can have numerous and non-specific manifestations at all stages, and may simulate other diseases, which can delay diagnose if not suspected.

A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by serologic testing after 6 to 10 months of age.

This study will observe the clinical presentation and the laboratory of patients with CS treated.


Eligibility criteria: Inclusion Criteria:

* Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete.
* Patients with compatible clinical signs of syphils.

Exclusion Criteria:

* Patients with diagnosis of acquired syphilis
* Patients whose medical records are missing

Primary outcomes:
measure: Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital
timeFrame: Past 30 years
Secondary outcomes:
measure: Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described.
timeFrame: Past 30 years
Other outcomes:
measure: Estimate the most frequent laboratory alterations in patients with CS
timeFrame: Past 30 years
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Study officials:
affiliation: Principal Investigator
name: Jaime Altcheh, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00309101: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Official title: FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis
Keywords: Tacrolimus
Myasthenia Gravis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed as myasthenia gravis
* Those whose MG symptoms are not controlled by the treatment with prednisone

Exclusion Criteria:

* Those who had undergone thymectomy

Primary outcomes:
measure: Improvement of clinical symptoms
timeFrame: 28 Weeks
Secondary outcomes:
measure: Improvement of daily activity
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Hokuriku region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04652401: Quality of Life in Ventilator-dependant Neuromuscular Patients
Official title: Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Respiration, Artificial
Tracheostomy
Noninvasive Ventilation
Quality of Life
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
name: AFM Téléthon
name: FilNeMus
First posted: 2020-12-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with slowly progressive neuromuscular disease using home mechanical ventilation for at least 16 hours a day since at least one year. Patients may be ventilated via invasive or noninvasive interface.

Brief summary: This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).


Eligibility criteria: Inclusion Criteria:

* Patients with slowly progressive neuromuscular disorder (NMD), non walking
* Patients dependant on mechanical ventilation (daily usage ≥ 16h) for at least 1 year before inclusion
* Aged ≥ 18 yo
* Consent for participation
* Affiliated to a social security regime

Exclusion Criteria:

* Patients with medically non-stable NMD: fever, acute respiratory infection, organ decompensation
* Patients with significant cognitive impairment (inability to read and/or incomprehension of questions)
* Patients with fast-evolving neuromuscular disease
* Patients declining to participate in the study
* Patients under guardianship and/or trusteeship
* Pregnant women

Primary outcomes:
measure: Score of the Severe Respiratory Insufficiency questionnaire (SRI)
timeFrame: 1 Day
measure: Score of the Quality of Life Measure for people with slowly progressive and genetic neuromuscular disease questionnaire (QoL-gNMD)
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Évry
country: France
facility: AFM Téléthon
Study officials:
affiliation: Université Paris-Saclay, UVSQ, ERPHAN, 78000, Versailles, FRANCE
name: Mathieu Delorme, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Paris-Saclay, UVSQ, ERPHAN, 78000, Versailles, FRANCE
name: Frederic Lofaso, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05926401: Atrial Fibrillation Prior and Post Elective Cardioversion
Official title: Atrial Fibrillation Prior and Post Elective Cardioversion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2023-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients satisfying the inclusion criteria will be recruited after informed written consent for study participation.

Brief summary: Cardioversion from atrial fibrillation (AF) to sinus rhythm (SR) is performed primarily to improve patient symptoms. However, due to the intermittent nature of AF, patients may have converted to SR prior to elective cardioversion and the recurrence rate of AF after cardioversion can be high. The aims of this study are to assess the rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion, as well as the rate of early recurrence of AF after elective cardioversion.


Eligibility criteria: Inclusion Criteria:

* Planned elective cardioversion of AF
* Informed written consent for participation

Exclusion Criteria:

* Lack of ability to cooperate
* Pacemaker/CRT device
* No smart phone

Primary outcomes:
measure: The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion
timeFrame: 10 days pre/post cardioversion
measure: The rate of early recurrence (<5 days) of AF after elective cardioversion
timeFrame: up to 5 days pre/post cardioversion
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
Study officials:
affiliation: Oslo university hospital /University of Oslo
name: Sigrun Halvorsen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02084901: Comparison of Biodegradable Stents: Orsiro and BioMatrix
Official title: Comparison of Biodegradable Stents: Orsiro and BioMatrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: All-comer
Percutaneous Coronary Intervention
Keywords: Biodegradable stents
converage
OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.

The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Detailed description: The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.

The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 20 years old
2. Patients in the treatment of subjects with all-comer who are to undergo PCI

Exclusion Criteria:

1. Pregnant women or women with potential childbearing
2. Life expectancy \< 1 year

Primary outcomes:
measure: Neointimal coverage at 3 month after stent implantation
timeFrame: At 3 months after stent implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Study officials:
References:
Clinical trial NCT00761501: Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Official title: Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Healthy Volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria:

* Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

Primary outcomes:
measure: Pharmacokinetics
timeFrame: pre-dose and multiple times post-dose
Secondary outcomes:
measure: Safety
timeFrame: Throughout study
Other outcomes:
Locations:
city: Lulea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Quintiles Hermelinen
name: Aslak Rautio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles Phase I Services
name: Wolfgang Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References: