louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05766943: Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
Official title: The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subcutaneous ICD
Myopotential Interference
Keywords: Device interrogation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-03-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

Detailed description: This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially, then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit. Following this visit study participation is complete.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)

Exclusion Criteria:

* Less than 18 years of age
* Hemodynamically unstable
* Inability to preform TET due to orthopedic issues or cognitive impairment

Primary outcomes:
measure: The incidence of myopotential interference
timeFrame: throughout the intervention, approximately 20 minutes
Secondary outcomes:
measure: Incidence of MPI in US participants and Japanese participants
timeFrame: duration of enrollment, approximately 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael R Gold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04595643: Outpatient Swallowing Therapy for Subjects With Neurological Illness
Official title: Outpatient Swallowing Therapy for Subjects With Neurological Illness - a Feasability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 5
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: Health care staff in the municipalities do not always have the necessary competencies to treat patients with dysphagia. At the present neurorehabilitation hospital dysphagia examinations for outpatients are provided.

The objective is to investigate the effect of a specialized outpatient dysphagia unit for subjects with dysphagia following neurological illness. Occupational therapists from the outpatient dysphagia unit will train with subjects for 2-3 weeks, and supervise furter training provided by health care staff in the municipalities.


Eligibility criteria: Inclusion Criteria:

* Neurological illness
* Living in the Region of central Jutland
* FEDSS score 2-6

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
timeFrame: Baseline and 14 days follow-up
measure: Change in Functional Oral Intake Scale (FOIS)
timeFrame: Baseline, immediately after the intervention, and 14 days follow-up
Secondary outcomes:
measure: Change in Penetration Aspiration Scale (PAS)
timeFrame: Baseline and 14 days follow-up
measure: Change in The Yale Pharyngeal Residue Severity Rating Scale
timeFrame: Baseline and 14 days follow-up
measure: Facio Oral Tract Therapy - Swallowing assessment of Saliva (FOTT-SAS)
timeFrame: Baseline, immediately after the intervention, and 14 days follow-up
measure: Dysphagia Handicap Index (DHI)
timeFrame: Baseline, immediately after the intervention, and 14 days follow-up
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Region Of Central Jutland
Study officials:
affiliation: Hammel Neurorehabilitation Centre and Univeristy Research Clinic
name: Jesper Fabricius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03655938: Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration
Official title: Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration : a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Requiring Mandible Orthodontic Treatment
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.


Eligibility criteria: Inclusion criteria:

* Patients requiring at least mandible orthodontic treatment (both arches)
* Patient presenting alveolar bone thickness \< XX mm
* Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
* Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
* American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
* Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries).

Exclusion criteria were as follows:

* Controlled periodontitis with a loss of alveolar support \> 10%
* Gingival recession \> 2 mm
* Smokers
* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
* Mental or motor disabilities
* Pregnancy

Primary outcomes:
measure: Radiographic change from Baseline and after 1year
timeFrame: Baseline and after 1year
Secondary outcomes:
measure: Periodontal Evaluation
timeFrame: Baseline and after 1 year
measure: Patient assessment
timeFrame: Baseline and after 1year
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU University of Liège
Study officials:
References:
citation: Charavet C, Lecloux G, Vandenberghe B, Lambert F. Buccal bone regeneration combined with piezocision in adult orthodontic patients: Clinical, 3D radiographic, and patient-reported outcomes. J Stomatol Oral Maxillofac Surg. 2021 Dec;122(6):549-556. doi: 10.1016/j.jormas.2020.10.005. Epub 2020 Oct 22.
Clinical trial NCT06379438: Treatment of Aphtous Ulcers With Photodynamic Therapy
Official title: Treatment of Aphtous Ulcers With Photodynamic Therapy: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Ulcer
Aphthous Recurrent Ulcers
Keywords: photodynamic therapy
aphtous ulcer
indocyanine green
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.

Detailed description: After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.

Eligibility criteria: Inclusion Criteria:

* ASA-1 patients without any systemic disease,
* With a history of canker sores not exceeding 2 days,
* Not taking any antibiotics or anti-inflammatory drugs.

Exclusion Criteria:

* Laser therapy contraindicated,
* Pregnancy,
* Smoking habbit,
* Poor oral hygiene,
* Patients under 18 years of age

Primary outcomes:
measure: Ulcer wound healing with diameter measurement
timeFrame: One week (preoperatively and on postoperative days 3, 5 and 7 )
measure: Level of recovery
timeFrame: Postoperatively 7 th day
Secondary outcomes:
measure: Pain evaluation with Visual Analogue Scale
timeFrame: One week
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
state: Merkez
Study officials:
affiliation: Yuzuncu Yıl University
name: Cennet N Eroglu, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520338: Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Official title: Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Thyroidectomy
Cyclooxygenase 2 Inhibitors
Keywords: celecoxib
postoperative pain
thyroidectomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2007-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether celecoxib is effective in the treatment postoperative pain after thyroidectomy.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib or placebo.

Detailed description: Postoperative pain has been concerned in the past few years by both the anesthesiologists ans the surgeons. COX2-inhibitors have played an important roles in postoperative pain with minimal side effects.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib and placebo.

Eligibility criteria: Inclusion Criteria:

1. Patient ASA physical status I-III.
2. Scheduled for an elective thyroidectomy.
3. Body weight \> or = 40kg
4. Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

1. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
2. Known hypersensitivity to morphine or sulfonamides.
3. History of hepatic dysfunction.
4. Creatinine clearance \< 30ml/min.
5. History of bleeding tendency.
6. History of gastrointestinal bleeding or active peptic ulcer.
7. Known case of inflammatory bowel disease.
8. Patient with severe heart failure.

Primary outcomes:
measure: The patients' total amount of morphine requirement in the first 24 hour.
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913038: Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.
Official title: Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Pediatric ALL
Keywords: Intensive Care Units,
Pain Measurement
ANI, Analgesia Nociception Index
Pediatric,
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care

Brief summary: The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.

In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.

To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.


Eligibility criteria: Inclusion Criteria:

* Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated

Exclusion Criteria:

* Non sinusal rythm
* Atropine
* Pace-macker

Primary outcomes:
measure: Analgesia Nociception Index (ANI) minimum
timeFrame: at 10 minutes before the painful care
measure: ANI minimum
timeFrame: at 30 minutes (average lenght of painful care)
measure: ANI minimum
timeFrame: at 10 minutes after the painful care
Secondary outcomes:
measure: Variation of ANI minimum between before and after a painful care
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: the correlation between ANI minimum and the COMFORT B behavioral scale.
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: the ability of ANI minimum to distingush painful from non painful patient
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: Area under the ROC curve of ANI min calculated over all measurements
timeFrame: From 10 minutes before the care to 10 minutes after the care
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Morgan RECHER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809038: Dry Needling Versus Magnesium Sulphate Iontophoresis in Subjects With Chronic Mechanical Neck Pain
Official title: Dry Needling Versus Magnesium Sulphate Iontophoresis in Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: dry needling, iontophoresis, neck pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this trial has three group; two experimental and one control
Primary purpose: TREATMENT

Brief summary: the aim of this trial is to compare dry needling and magnesium sulphate iontophoresis in subjects with mechanical neck pain

Detailed description: Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band.

dry needling and iontophoresis play a major role in the treatment of mechanical neck pain so this trial was conducted to determine which one has superiority. this trial has three groups. two experimental and one control group.pain, function, pressure pain threshold and emg will be measured

Eligibility criteria: Inclusion Criteria:

All patients had active trigger myofascial trigger points (MTrPs) in upper trapeziues muscle in the dominant side with mechanical neck pain.

The patients age ranged from 18-35years The patients had been choosen from both sexes . patient agrees not to receive additional treatment for their painful condition during the trial (apart from NSAIDs and pain killers The patients body mass index \< 30 kg/m²

Exclusion Criteria:

History of whiplash injury History of cervical spine surgery Cervical radiculopathy or myelopathy Having undergone physical therapy within the past 3 months before the study. Non -rheumatologic diseases as multiple sclerosis , thyroid dysfunction and chronic infection

Primary outcomes:
measure: pain intensity
timeFrame: up to four weeks
measure: muscle activity in the form of normalized root mean square
timeFrame: up to four weeks
Secondary outcomes:
measure: function
timeFrame: up to four weeks
measure: pressure pain threshold
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Shaymaa Shaaban Abd El Azeim
Study officials:
References:
Clinical trial NCT01357538: Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
Official title: Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Signs and Symptoms
Keywords: Bibrocathol
eye ointment
blepharitis
eye lid
Lead sponsor: Ursapharm Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 197
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: This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.

Detailed description: Reduction of signs and symptoms of blepharitis

Eligibility criteria: Inclusion Criteria:

* written informed consent
* ambulatory male and female patients 18 years of age or older
* summarised score of signs and symptoms of blepharitis of 15 or more at baseline

Exclusion Criteria:

* different ocular conditions
* different system conditions
* several concomitant medications

Primary outcomes:
measure: Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
timeFrame: 14 days
Secondary outcomes:
measure: Changes in blepharitis signs and symptoms
timeFrame: 14 days
Other outcomes:
Locations:
city: Kharkov
country: Ukraine
facility: Kharkov District Clinical Hospital
Study officials:
affiliation: Kharkov District Clinical Hospital
name: Pavel A Bezdetko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25.
Clinical trial NCT00936338: Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herniated Disk
Temporomandibular Disorders
Keywords: anterior disc displacement without reduction of temporomandibular disorders
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Fifty two subjects were assigned at random to either of two treatment groups: one is a splint treatment group, and the other is a joint mobilization self exercise group. Each treatment was evaluated using four outcome variables: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities. All outcome variables were significantly improved after eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three variables, other than "mouth opening with pain"; however, the degree of improvement was less than that seen in the exercise group. This result demonstrates that the joint mobilization self exercise improves jaw function and relieves pain as compared to the splint treatment.


Eligibility criteria: Inclusion Criteria:

* (1) male or female over 18 years old;
* (2) with mouth opening pain on the TMJ affected side;
* (3) over two weeks after the onset of ADDwoR;
* (4) with maximum mouth opening of less than 40 mm; and
* (5) MRI-confirmed ADDwoR. The

Exclusion Criteria:

* (1) unwilling or unable to receive splint and/or exercise therapy;
* (2) with systemic bone or joint disease,
* (3) regular medication such as analgesics, anti-anxiety drugs, antidepressants and psychotropics; and
* (4) missing teeth and/or a removable denture but having a fixed partial denture restoration over one year.

Primary outcomes:
measure: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities
timeFrame: 0, 4 and 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: TMJ Clinic, Tokyo Medical and Dental University
Study officials:
References: