louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03683862: Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers
Official title: Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Retention Compliance
Keywords: hawley
thermoplastic
orthodontic retention
compliance
vacuum- formed
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 77
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).


Eligibility criteria: Inclusion Criteria:

* patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch
* age 12- 18

Exclusion Criteria:

* systematic diseases
* craniofacial anomalies (clefts, etc)
* handicapped patients with problems of compliance
* pregnant women
* previous orthodontic treatment or compromise orthodontic treatment

Primary outcomes:
measure: Compliance of retainer wear
timeFrame: 3 months
Secondary outcomes:
measure: Compliance of retainer wear
timeFrame: 1 month
measure: Association between objective compliance assessment and diary reported hours
timeFrame: 3 months
measure: Association between objective compliance assessment and diary reported hours
timeFrame: 1 month
Other outcomes:
Locations:
city: Athens
country: Greece
facility: School of Dentistry, Department of Orthodontics, National and Kapodistrian University of Athens
Study officials:
affiliation: School of Dentistry, National and Kapodistrian University of Athens
name: Georgia Vagdouti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vagdouti G, Karvouni E, Bitsanis E, Koletsi D. Objective evaluation of compliance after orthodontic treatment using Hawley or vacuum-formed retainers: A 2-center randomized controlled trial over a 3-month period. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):717-726.e2. doi: 10.1016/j.ajodo.2019.07.008.
Clinical trial NCT05666362: Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
Official title: Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.


Eligibility criteria: Inclusion Criteria:

Preterm infants with gestational age ≤34 weeks or infant with birth weight ≤ 2.000 Kg regardless their gestational age,with postnatal age ≥ 28 days undergoing routine ROP screening.

Exclusion Criteria:

Patients with any of the following will be excluded at the time of assessment:

* Evidence of intrauterine infection (TORCH).
* Chromosomal abnormalities.
* Major congenital anomalies.
* Major brain pathology such as Grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.

Primary outcomes:
measure: 1-Clinical assessment:
timeFrame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
measure: 2-Near-infrared spectroscopy (NIRS):
timeFrame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Marwa Mohamed Farag
Study officials:
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Shimaa Hafez, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Hesham Ghazal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06129162: Pain Perception Comparison of Computerized vs Conventional Injection Methods
Official title: A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Perception
Local Anesthesia
Keywords: Pain perception
Inferior Alveolar Nerve
Infiltration
Local Anesthesia
STA Single Tooth Anesthesia® System
Star Pen anesthesia device
Conventional syringe
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected children will be divided randomly into 3 groups:

* Control group (Group I).
* STA group (Group II).
* Star pen group (Group III).
Primary purpose: OTHER

Brief summary: This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.

Detailed description: The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.

Eligibility criteria: Inclusion Criteria:

1. Apparently healthy children (5-8) years old, and free from systemic diseases.
2. Children who require local anesthetic injection for any dental treatment.
3. Cooperative children (positive or definitely positive on Frankel's scale).
4. Children who have no contraindications to the usage of selected local anesthetic agents.

Exclusion Criteria:

* All that does not correspond to inclusion criteria.

Primary outcomes:
measure: scale of pain perception by Wong-Baker FACES Pain Rating scale
timeFrame: Up to 12 weeks.
measure: scale of pain perception by Sounds, eyes, and motor (SEM) scale.
timeFrame: Up to 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry
state: Dakahlia
Study officials:
affiliation: Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Osamah M Almekhlafi, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
name: Salwa M Awad, Prof
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: Rizk A Elagamy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03560362: Postoperative Pain Control With Lipossomic Extended Release Bupivacaine
Official title: Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pain, Postoperative
Lung Cancer
Keywords: bupivacaine
lipossomal extended release bupivacaine
Intercostal nerve block
thoracic surgery
minimally invasive surgery
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Detailed description: Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.

Eligibility criteria: Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery

* Patients who will be undergoing minimally invasive thoracic surgery

Exclusion Criteria:

* Open surgery
* Chronic use of narcotics
* Use of pregabalin or similar
* Significant liver or kidney dysfunction

Primary outcomes:
measure: Postoperative pain
timeFrame: 3-5 days post op
Secondary outcomes:
measure: Postoperative complications
timeFrame: 90 days post op
measure: Narcotic used
timeFrame: 3-5 days post op
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Benny Weksler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05540262: Edaravone in the Treatment of Optic Neuritis
Official title: Edaravone in the Treatment of Optic Neuritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Optic Neuritis
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.


Eligibility criteria: Inclusion Criteria:

1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
2. Patients with a first episode of optic neuritis in either eye
3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone

Exclusion Criteria:

1. Myopia over 6 diopters
2. Refractive media opacity affecting assessment of retinal layers and/or visual acuity

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: 18 months
Secondary outcomes:
measure: Ganglion cell-inner plexiform layer
timeFrame: 18 months
measure: Peripapillary retinal nerve fiber layer
timeFrame: 18 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: Yi Du
Study officials:
References:
Clinical trial NCT05130762: A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
Official title: A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Complication
Vascular Access Site Management
Disinfecting Cap
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 157
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).

Detailed description: This is a multi-center, prospective observational study of a minimum of 150 study participants who have vascular access devices (VADs) with needle-free connectors as part of their routine medical care.

Patients will be followed from the time of enrollment through the duration of VAD therapy or 45 days post enrollment date, whichever comes first.

Eligibility criteria: Inclusion Criteria:

1. Has an eligible vascular access device with needle-free connectors in situ or will have one placed Note: This covers all needle-free devices, including central venous catheters, peripheral IV catheters and arterial VADs
2. Is expected to receive VAD therapy for a minimum of 3 days
3. Is expected to be available for regular observation from consent until end of study
4. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant

Exclusion Criteria:

1. BD PureHub™ Disinfecting Cap or any other disinfecting cap in place for more than twelve (12) hours (\>12 hours) prior to study participation
2. Presence of any infection, bacteremia, or septicemia is known or suspected
3. Any condition which, in the opinion of the Investigator, precludes the participant from participation in this study

Primary outcomes:
measure: Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector
timeFrame: Up to 45 days post-enrollment date
measure: Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.
timeFrame: Up to 45 days post-enrollment date
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
city: Antwerp
country: Belgium
facility: UZA
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Valencia
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
References:
Clinical trial NCT01655862: A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA
Official title: Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Torticollis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cervical Dystonia (Dystonie)

Brief summary: This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

Exclusion Criteria:

* Participation in a clinical trial for any botulinum toxin indication
* Planning elective surgery during the observational study period
* Treatment with any botulinum toxin product for cervical dystonia (dystonie)
* Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start

Primary outcomes:
measure: Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score
timeFrame: Baseline, 96 Weeks
Secondary outcomes:
measure: Patient's Global Impression of Change (PGIC) Using a 7-Point Scale
timeFrame: Baseline, 96 Weeks
measure: Work Productivity Assessment Using a 10-Item Questionnaire
timeFrame: 96 Weeks
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score
timeFrame: Baseline, 96 Weeks
measure: Reasons for Withdrawal of Treatment
timeFrame: 96 Weeks
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
facility: Clinique Neuro-Rive Sud
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Chum-Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Queen Elizabeth Health Centre: Medical Specialist Clinic
state: Quebec
city: Sherbrooke
country: Canada
facility: CHU - Sherbrooke
state: Quebec
city: St-Romuald
country: Canada
facility: Polyclinique Medicale des Ponts
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec, Hôpital de l'Enfant-Jésus
city: Quebec
country: Canada
facility: Centre Medical Le Mesnil
Study officials:
affiliation: Allergan
name: Goran Davidovic
role: STUDY_DIRECTOR
References:
Clinical trial NCT02992262: Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
Official title: Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papilledema Associated With Increased Intracranial Pressure
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-12-14
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pediatric emergency department (PED) physicians frequently encounter children with symptoms that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP) such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED physician, is considered an essential modality for assessment of the optic disc and the diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient compliance, the ability to open the eyelids, the absence of opacities in the ocular media and a sufficiently large pupillary aperture. Hence, different levels of PED physician training, lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis and severe photophobia may hinder direct fundoscopic evaluation.

In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic examination. The investigators aim to evaluate the yield of optic disc height as measured with ocular point of care ultrasound to detect optic disc swelling in comparison to ophthalmologic examination as the gold standard.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients from the PED,
* Aged 0-18 years,
* Who require funduscopic examination and referred to ophthalmologic evaluation.

Exclusion Criteria:

* Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid,
* History of glaucoma.

Primary outcomes:
measure: The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard.
timeFrame: Up to 24h from inclusion or until hospital discharge if admitted
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00491062: Enteric Nervous System in Parkinson's Disease
Official title: Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
enteric nervous system
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2007-06-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: The "core" of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease patients at 3 different stages:

  * Early PD (before L-DOPA-induced complication);
  * Patients with L-DOPA-induced complication;
  * Patients with balance impairment or cognitive decline.
* Controls: patient at risk of colic cancer for whom a coloscopy is required.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes Gastro-enterologic and Neurologic Service
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: DAMIER Philippe
role: STUDY_DIRECTOR
References:
citation: Lebouvier T, Neunlist M, Bruley des Varannes S, Coron E, Drouard A, N'Guyen JM, Chaumette T, Tasselli M, Paillusson S, Flamand M, Galmiche JP, Damier P, Derkinderen P. Colonic biopsies to assess the neuropathology of Parkinson's disease and its relationship with symptoms. PLoS One. 2010 Sep 14;5(9):e12728. doi: 10.1371/journal.pone.0012728.