louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06795282: Post Operative Sensitivity of MTA Obturation
Official title: Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Pulp Disease
Endodontically Treated Teeth
Endodontic Disease
Keywords: MTA
Post-op pain
Epoxy resin sealer
putty MTA
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Systemically healthy patients between the ages of 18-65

Brief summary: The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.


Eligibility criteria: Inclusion Criteria:

* asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
* large pulp perforation during caries removal,
* inflamed pulp in which bleeding could not be controlled within 5 min,
* periodontally healthy mature mandibular first or second molar tooth.

Exclusion Criteria:

* patients if they were diabetic, immunocompromised, pregnant,
* had a positive history of antibiotic use during the past 1 month,
* required antibiotic prophylaxis
* used analgesic within 7 days prior to the beginning of treatment,
* were allergic to the materials used during root canal treatment,
* if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
* the tooth had negative response to vitality tests and/or was symptomatic,
* had an associated periapical lesion visible on a radiograph,
* needed a post-core or was planned to serve as prosthetic support,
* had a calcified root canal and internal or external root resorption,
* had tooth with open apex
* mandibular third molars

Primary outcomes:
measure: 10-day postoperative pain after root canal treatment
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01513382: Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.
Official title: Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus
Methylene blue
Histopathology
Surgery
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.

Detailed description: To study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. The branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any.

Eligibility criteria: Inclusion Criteria:

* Pilonidal sinus disease of the intergluteal region
* Primary disease without history of drainage
* Ages between 18 and 65, both gender

Exclusion Criteria:

* Recurrent pilonidal sinus disease
* Acute infection with abscess formation and/or purulent copious drainage
* Denial to sign informed consent

Primary outcomes:
measure: Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
Study officials:
affiliation: Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
name: Suleyman Bozkurt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University, Faculty of Medicine, Department of Surgery
name: Erhan Aysan, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Doll D, Novotny A, Rothe R, Kristiansen JE, Wietelmann K, Boulesteix AL, Dusel W, Petersen S. Methylene Blue halves the long-term recurrence rate in acute pilonidal sinus disease. Int J Colorectal Dis. 2008 Feb;23(2):181-7. doi: 10.1007/s00384-007-0393-9. Epub 2007 Oct 25.
citation: Soll C, Hahnloser D, Dindo D, Clavien PA, Hetzer F. A novel approach for treatment of sacrococcygeal pilonidal sinus: less is more. Int J Colorectal Dis. 2008 Feb;23(2):177-80. doi: 10.1007/s00384-007-0377-9. Epub 2007 Aug 17.
citation: Mentes O, Oysul A, Harlak A, Zeybek N, Kozak O, Tufan T. Ultrasonography accurately evaluates the dimension and shape of the pilonidal sinus. Clinics (Sao Paulo). 2009;64(3):189-92. doi: 10.1590/s1807-59322009000300007.
Clinical trial NCT03410082: Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
Official title: A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bispectral Index, Monitored Anesthesia Care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.


Eligibility criteria: Inclusion Criteria:

* Patients receiving ear surgery with ASA physical status 1 or 2

Exclusion Criteria:

* Age under 19 years
* Pregnancy
* Cognitive disorder affecting daily activity
* Patients who cannot participate in the survey
* Allergy to the medication
* History of sedative abuse

Primary outcomes:
measure: Iowa Satisfaction with Anesthesia Scale(ISAS)
timeFrame: within 30 minutes after the end of surgery (in the PACU)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Agree
Study officials:
References:
Clinical trial NCT00213382: Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects
Official title: Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: swallowing
ventilation
pressure
EMG
cortical magnetic stimulation
Brain Mapping
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: The aims of this study are in four experimental sessions. The aims are:

* to characterize the excitability of the cortical pharyngeal area with pharyngeal pressure and electromyograms (EMGs), at rest, in awake healthy subjects;
* to study its facilitation by inspiration and deglutition; and
* to study its plasticity by respiration and swallowing.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Eric Verin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University CHU Rouen
name: Eric Verin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691782: The Impact of African American Women's Hair Care Practices and Hair Attitudes on Exercise Habits
Official title: The Impact of African American Women's Hair Care Practices and Hair Attitudes on Exercise Habits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hair and Scalp Health
Keywords: African American females between the ages of 21 and 60
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American females between the ages of 21 and 60.These subjects will be recruited from Wake Forest University Health Sciences Dermatology clinic and our Institutional Review Board (IRB) approved advertising.

Brief summary: The purpose of this research study is to better understand African American women's hair and hair styling practices and how these practices affect attitudes and viewpoints regarding exercise.


Eligibility criteria: Inclusion Criteria:

* Female between 21 and 60 years old.
* African, Afro-Caribbean, or African American decent.
* Able and willing to follow study procedures and successfully complete hair and exercise questionnaire/survey.

Exclusion Criteria:

* Unable to read or understand hair and exercise questionnaire/survey.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06024382: The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
Official title: The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: twin block , functional appliance , low level laser , photobiomodulation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment


Eligibility criteria: Inclusion Criteria:

* Age (early permanent dentition)
* Cervical maturation stage CS 3-4
* Skeletal class II due to mandibular retrusion.
* Overjet more than 4mm.

Exclusion Criteria:

* Cleft lip or palate.
* Systemic diseases.
* Previous orthodontic treatment or abnormal habits.
* Congenital craniofacial deformity.
* poor oral hygiene

Primary outcomes:
measure: treatment time
timeFrame: 8 months
Secondary outcomes:
measure: cephalometric measurements
timeFrame: 8 months
measure: study cast analysis
timeFrame: 8 months
measure: the short form McGill pain questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
state: Dakahleya
Study officials:
References:
Clinical trial NCT02835482: Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Cataract
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-07-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).

If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.

No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.

Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.

The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.


Eligibility criteria: Inclusion Criteria:

* scheduled bilateral cataract surgery
* bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).

Exclusion Criteria:

* ophthalmologic pathology known other than glaucoma
* diabetes

  * untreated hypertension
  * multiple sclerosis
  * Graves' disease
  * sarcoidosis
  * patient taking toxic drug for the optic nerve and the retina
  * neurodegenerative disease
  * all general diseases that can affect the ocular structures
  * eye surgery history
  * patient's opposition to participation in the study, according to the law on research into routine care
  * absence of affiliation to social security or to universal medical coverage
  * legally protected patient
  * pregnancy or breastfeeding

Primary outcomes:
measure: In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.
timeFrame: within the first 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT03211182: Lifestyle Modification Intervention in Pre-diabetic Subjects
Official title: Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Keywords: lifestyle intervention
prediabetes
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2017-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

Detailed description: The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.

Eligibility criteria: Inclusion Criteria:

* 40 years old or over
* elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)

Exclusion Criteria:

* having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years
* having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment
* receiving corticosteroids, androgens, estrogen containing compounds
* who had dietary problem
* pregnant women
* who joined other health intervention study in one year.

Primary outcomes:
measure: blood sugar
timeFrame: 3 month, 6 month and 12-month follow up
Secondary outcomes:
measure: body weight
timeFrame: 3 month, 6 month and 12-month follow up
measure: BMI
timeFrame: 3 month, 6 month and 12-month follow up
measure: Metabolic syndrome
timeFrame: 3 month, 6 month and 12-month follow up
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: YUANH
state: Lingya Dist
city: Taipei
country: Taiwan
facility: SKH
state: Shilin Dist.
city: Taipei
country: Taiwan
facility: TMUH
state: Sinyi District,
city: Taipei
country: Taiwan
facility: MMH
state: Zhongshan Dist.
Study officials:
affiliation: School of Public Health, Taipei Medical University
name: Hung-Yi Chiou, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04647682: Physical Activity Program Implementation in Hospitalized Positive COVID-19 Older Adults
Official title: Feasibility and Effect of Implementing Physical Activity Program Implementation During COVID-19 in Hospitalized Positive COVID-19 Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Keywords: older adults
hospital
physical activity program
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 62
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included in a French COVID-19 geriatric unit in Toulouse, hospitalized for a positive COVID-19 infection

Brief summary: Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit

Detailed description: The 30 second chair test, balance with joint-feet and semi-tandem stance, and 4 meters comfortable walking test were evaluated. Depending on their score, a specific physical activity (PA) program was selected and explained. The program was printed, explained and left in the room. This intervention included 5 different PA programs.

Final evaluation (one day before leaving the unit) recording physical performance (same physical tests used for inclusion evaluation), Hospital Anxiety and depression (HAD) score, Activities Daily Living (ADL) and self-satisfaction of the program.

Eligibility criteria: Inclusion Criteria:

* Patients aged 75 years and over
* Hospitalized in a French COVID-19 geriatric unit
* Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.

Exclusion Criteria:

* Exclusion of patients of palliative care,
* Severe dementia or Mini Mental State Examination (MMSE) \[14\] below 18/30
* Acute COVID-19 complication.
* Activities of Daily Living \< 2/6

Primary outcomes:
measure: Change of adherence of the intervention
timeFrame: through study completion, an average of 15 days
Secondary outcomes:
measure: Change of physical performances
timeFrame: through study completion, an average of 15 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe-à-Pitre Abîmes - GUADELOUPE
Study officials:
affiliation: University Hospital, Toulouse
name: Yves ROLLAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andre L, Rolland Y, Gerard S, Kergoat MJ, Peyrusque E, Aubertin-Leheudre M. Feasibility and Effect of Implementing Physical Activity Program Implementation during Covid-19 in Hospitalized Positive Covid-19 Older Adults. J Nutr Health Aging. 2021;25(6):724-726. doi: 10.1007/s12603-021-1596-4. No abstract available.
Clinical trial NCT05235282: Effect of Oral Neuromuscular Training on Swallowing
Official title: Effect of Oral Neuromuscular Training on Swallowing Function and Time Until Decannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Hammel Neurorehabilitation Centre and University Research Clinic
First posted: 2022-02-11
Enrollment: 22
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: In this randomized controlled trial the investigators wish to investigate the effect of an oral neuromuscular training device (called IQoro) on swallowing function and time until decannulation from a tracheostomy tube, in patients admitted for neurorehabilitation due to a severe acquired brain injury.


Eligibility criteria: Inclusion Criteria:

* Cuff tracheostomy tube

Exclusion Criteria:

* Not able to comply with IQoro exercises
* 3 weeks evaluation stay at the hospital

Primary outcomes:
measure: Number of days from admission until decannulation
timeFrame: Number of days from baseline assessment until decannulation or right censoring at 365 days
Secondary outcomes:
measure: Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS)
timeFrame: Baseline and after four weeks
measure: Penetration Aspiration Scale (PAS)
timeFrame: Baseline and after four weeks
measure: Yale Pharyngeal Residue Scale
timeFrame: Baseline and after four weeks
measure: Milliliters of saliva above the cuff
timeFrame: Daily measures for up to four weeks
measure: Functional oral intake (FOIS)
timeFrame: Baseline and after four weeks
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: Baseline and after four weeks
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Midtjylland
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Jesper Fabricius, PhD
role: PRINCIPAL_INVESTIGATOR
References: