louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06734364: Buddy Tape Vs. Splint for Metacarpal Shaft Fracture Recovery
Official title: Functional Treatment of Non-thumb Metacarpal Shaft Fractures. Randomized Study Evaluating Buddy Taping Versus Splint on Functional Recovery of the Hand
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-thumb Metacarpal Shaft Fracture
Keywords: Metacarpal shaft fracture
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 96
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: The goal of this clinical trial is to see if buddy tape can treat shaft fracture of hand long fingers as well as splint.

The main question it aims to answer is: Two months after the fracture, are the hand activities as good with buddy taping as with splint? Researchers will compare buddy tape group to splint group to see if the strength of the arm is not lower with buddy tape.

Participants will attend 4 visits after receiving either buddy tape or splint, to control their hand strength and the correct healing of their franture.

Detailed description: Patients will be identified in the emergency ward after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the buddy taping or the short arm splint group. This decision will be made through randomization, and the physician will not select which group the patient is in.

As in routine practice, the patients are seen again on D15 ± 3 days, D30 ± 5 days and D60 ± 5 days in an orthopedic consultation with X-ray to control the hand face, strict profile and 3/4. Both devices are removed at the check-up consultation on day 30 ± 5 days.

The patients will then attend the end of trial visit at Day 90 ± 5 days in an orthopedic consultation with X-ray.

No specific act is added by this research.

Eligibility criteria: Inclusion Criteria:

1. Adult patient
2. Fingers 2 to 5 metacarpal shaft fracture, little or no displacement
3. Tilt less than or equal to thirty degrees
4. No rotation disorder
5. Patient who has given consent to participate in the study and has signed an informed consent

Exclusion Criteria:

1. Surgical treatment indicated
2. Patient pregnant or likely to be pregnant
3. Patient who does not speak or understand French
4. Subject under guardianship or curatorship
5. Subject not beneficiary of a social security system.

Primary outcomes:
measure: Quick Dash
timeFrame: day 60
Secondary outcomes:
measure: clamp force
timeFrame: day 0,15,30,60 and 90
measure: Grip force
timeFrame: day 0,15,30,60 and 90
measure: TPM
timeFrame: day 0,15,30,60 and 90
measure: TAM
timeFrame: day 0,15,30,60 and 90
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
Clinical trial NCT01230164: Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
Official title: Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Individuals With Visual Aberrations
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects over the age of 18 with visual abberations.

Brief summary: An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye.

The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch \& Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.


Eligibility criteria: Inclusion Criteria:

* male or female, at least 18 years of age
* no ocular abnormality other than refractive error
* patient in generally good \& stable overall health
* has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam
* corneal topography must be normal, as judged by the investigator
* topical anesthesia and mydriatics must be tolerated
* patient must be able to fixate steadily
* ability to understand and provide informed consent to participate in this study

Exclusion Criteria:

* history of ocular surgery
* history of ocular trauma, infection, disease, or abnormality other than refractive error
* myopia or hyperopia \> 7.0 D, astigmatism \>3.0 D
* uncorrectable visual acuity below 20/20
* abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage
* pupil sizes below 6.0 mm under mydriasis
* iris problems including, but not limited to, coloboma and previous iris surgery
* ocular media problems, corneal, lens and/or vitreous opacities including, but not limited to cataract
* ocular movement abnormalities including, but not limited to, strabismus or nystagmus
* phenol red thread test (Zone Quick-Menicon Ltd) less than 9 mm/15 seconds
* pregnancy and lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Roberto Pineda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04705064: Artificial Intelligence and Postoperative Acute Kidney Injury
Official title: Development and Prospective Validation of an Artificial Intelligence Model to Predict Postoperative Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-cardiac Surgery
Keywords: Artificial Intelligence
Postoperative acute kidney injury
Prospective validation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients undergoing non-cardiac surgery

Brief summary: The main objective of this study is to develop and validate an artificial intelligence model that predicts postoperative acute kidney injury.

Detailed description: Postoperative acute kidney injury is known to increase the length of hospital stay and healthcare cost. A lot of risk prediction models have been developed for identifying patients at increased risk of postoperative acute kidney injury. Recent advances in artificial intelligence make it possible to manage and analyze big data. Prediction model using an artificial intelligence and large-scale data can improve the accuracy of prediction performance. Furthermore, the use of an artificial intelligence may be a useful adjuvant tool in making clinical decisions or real-time prediction if it is integrated into the electrical medical record systems. However, before implementing an artificial intelligence model into the clinical setting, prospective evaluation of an artificial intelligence model's real performance is essential. However, to our knowledge, there was no artificial intelligence model for prediction of postoperative acute kidney injury, which was prospectively evaluated. Therefore, we aimed to develop an artificial intelligence model which predicts postoperative acute kidney injury and evaluate the model's performance prospectively.

Eligibility criteria: Inclusion Criteria:

* Adults patients undergoing non-cardiac surgery

Exclusion Criteria:

* Age under 18 years
* Surgery duration \< 1 hour
* Transplantation surgery
* Nephrectomy
* Cardiac surgery
* Patients who had severe kidney dysfunction preoperatively as follows:
* Serum creatinine ≥ 4 mg/dl
* Estimated glomerular filtration rate \<15 ml/min/1.73m2
* History of renal replacement therapy
* Patients who had no results of preoperative or postoperative serum creatinine

Primary outcomes:
measure: the incidence of postoperative acute kidney injury
timeFrame: during the postoperative seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyung-Chul Lee
Study officials:
References:
Clinical trial NCT06089564: Effectiveness of Skit Video to Improve Oral Hygiene Status of Children With Hearing Impairment
Official title: Enhancing Oral Hygiene in Children With Hearing Impairment: The Impact of Skit Video Interventions - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired Children
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction: Oral health is considered as a vital component of overall health and its importance in children may not be disregarded. In children with hearing impairment, communication barriers may hamper their understanding of oral hygiene practices, making them particularly vulnerable to dental problems. Objective: The objective of this study was to compare effectiveness of skit video, pictorial and sign language interventions to improve oral hygiene status of children with hearing impairment. Methods: Sixty children were completed the study and allocated randomly into each group with twenty children as follows: group A: Skit video, group B: Pictorial, and group C: Sign language. Mean gingival and OHI scores were recorded before and after implementation of interventions. Oral hygiene habits, oral hygiene and gingival index scores were recorded by structured questionnaire.


Eligibility criteria: Inclusion Criteria:

* Children with hearing impairment and total hearing loss at birth
* Aged 7 to 20 years for both genders,
* Minimum of 20 teeth in the oral cavity
* Children with mild, moderate, and severe gingivitis

Exclusion Criteria:

* Children with dental plaque covered more than two-thirds of their tooth surface, had a plaque score of \>1.0
* Children with fair to poor oral hygiene
* Children who had previously participated in any activity or programme promoting oral health within the previous six months
* Children with mild to moderate hearing loss
* Children taking long-term antibiotics
* Children who had used mouthwash within the previous three months
* Children with any known systemic diseases
* Presence of extensive dental calculus
* Uncooperative children

Primary outcomes:
measure: Plaque Index
timeFrame: one month
measure: Gingival Index
timeFrame: one month
Secondary outcomes:
measure: Oral Hygiene Index
timeFrame: One month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: ABSA School and college for deaf
state: Sindh
city: Karachi
country: Pakistan
facility: Ida Rieu College For Blind And Deaf
state: Sindh
Study officials:
affiliation: Bahria University Dental College
name: Maria Moin, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652964: PHOX2B Mutation-Confirmed Congenital Central Hypoventilation Syndrome in A Chinese Family: Presentations From Newborn to Adulthood
Official title: PHOX2B Mutation-Confirmed Congenital Central Hypoventilation Syndrome in A Chinese Family: Presentations From Newborn to Adulthood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Alveolar Hypoventilation Syndrome
Keywords: sleep apnea, PHOX2B, hypoventilation, polysomnography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-04-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A Chinese family of CCHS with presentations from newborn to adulthood and genetic analysis confirming the PHOX2B mutation was analyzed. After identifying central hypoventilation in an adult male (index case), clinical evaluation was performed on the complete family, which consisted of the parents, five siblings, and five offsprings. In addition, pulmonary function test, overnight polysomnography, arterial blood gas, and hypercapnia ventilatory response, and genetic screening for PHOX2B gene mutations were performed on living family members.

Brief summary: Detect the PHOX2B Mutation-confirmed congenital central hypoventilation syndrome

Detailed description: Background: Congenital central hypoventilation syndrome (CCHS) is characterized by compromised chemo-reflexes that results in hypoventilation during sleep. Recently, a heterozygous PHOX2B gene mutation was identified in CCHS. This report was made to increase physicians' awareness of this rare disease.

Methods: A Chinese family of CCHS with presentations from newborn to adulthood and genetic analysis confirming the PHOX2B mutation was analyzed. After identifying central hypoventilation in an adult male (index case), clinical evaluation was performed on the complete family, which consisted of the parents, five siblings, and five offsprings. In addition, pulmonary function test, overnight polysomnography, arterial blood gas, and hypercapnia ventilatory response, and genetic screening for PHOX2B gene mutations were performed on living family members.

Eligibility criteria: Inclusion Criteria:

* Members of familiar congenital central hypoventilation syndrome

Exclusion Criteria:

* Refuse to participate study

Primary outcomes:
measure: respiratory failure
timeFrame: cross sectional observation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Naitonal Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Peilin Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01283464: Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
Official title: Double-blinded, Single-center, Parallel-arm Comparison Study of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Photodamaged Skin
Wrinkles
Keywords: Retinol
Tretinoin
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.


Eligibility criteria: Inclusion Criteria:

* Age 35 or over
* Moderate to severe photodamage

Exclusion Criteria:

* History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
* History of keloids or hypertrophic scars
* Use of oral steroids or oral retinoids (such as Accutane) in past 6 months

Primary outcomes:
measure: Global Photodamage Severity
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Dept. of Dermatology
state: Maryland
Study officials:
References:
citation: Chien AL, Kim DJ, Cheng N, Shin J, Leung SG, Nelson AM, Zang J, Suh H, Rainer B, Wallis L, Okoye GA, Loss M, Kang S. Biomarkers of Tretinoin Precursors and Tretinoin Efficacy in Patients With Moderate to Severe Facial Photodamage: A Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):879-886. doi: 10.1001/jamadermatol.2022.1891.
Clinical trial NCT04877964: Ultrasound Measured Epidural Depth for Midline Approach in Pediatric Patients With Scoliosis: Prospective Observational Study
Official title: Ultrasound Measured Epidural Depth for Midline Approach in Pediatric Patients With Scoliosis: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients (aged 3-14 years) with scoliosis (cobb angle \>10 degree) scheduled for correctional osteotomy of the lower extremity and requesting epidural analgesia for postoperative pain control

Brief summary: The purpose of this study was to

1. investigate the degree of agreement between the ultrasound-measured depth (in the transverse median and paramedian sagittal oblique plane) and the actual depth to the epidural space in pediatric patients with scoliosis.
2. investigate the quality of ultrasound view for detecting ligamentum flavum and dura mater.


Eligibility criteria: Inclusion Criteria:

1. pediatric patients (aged 3-14 years) with scoliosis (cobb angle \>10 degree) scheduled for correctional osteotomy of the lower extremity and requesting epidural analgesia for postoperative pain control

Exclusion Criteria:

1. Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
2. If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)

Primary outcomes:
measure: the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space
timeFrame: Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion
measure: the quality of ultrasound view for detecting ligamentum flavum and dura mater (in the transverse median and paramedian sagittal oblique plane)
timeFrame: Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine
name: Hye Jin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356064: Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei
Official title: Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spur, Heel
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.


Eligibility criteria: Inclusion Criteria;

* Presence of heel pain for at least four weeks,
* Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
* Agreed to participate in the study.

Exclusion Criteria:

* History of fracture or surgery,
* Polyneuropathy,
* Rheumatological diseases,
* Coagulation disorders,
* Tumor,
* Thrombosis,
* Soft tissue or bone infection,
* Pregnancy and lactation,
* Epilepsy,
* Presence of a pacemaker.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before and after treatment baseline, 4th week, 12 th week
measure: Functional Foot Index
timeFrame: Before and after treatment baseline, 4th week, 12 th week
Secondary outcomes:
measure: Radiographic assesment, epin size
timeFrame: Before and after treatment baseline, 4th week, 12 th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özge TEZEN
Study officials:
References:
Clinical trial NCT01226264: Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence
Official title: Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Cervical Cancer
Diffusion-weighted MRI
Recurrence
Keywords: Uterine cervical cancer
diffusion-weighted MRI
recurrence
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an emerging MRI imaging technique which has a potential value for the detection of primary and recurrent disease and for the assessment of response to therapy. The purpose of this project is to evaluate the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide early information about the response to therapy. This could enable the identification of less- or non-responsive tumors and in this way therapy can be adapted as soon as possible. Hence the investigators could offer the patient a more efficient treatment scheme and a reduction in toxicity related to the treatment could be established.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with cervical uterine cancer are, on a voluntary basis, enrolled in the study. These are patients who either underwent curative chemoradiation (mainly patients with advanced stage cancer) or neoadjuvant chemotherapy (predominantly in patients with early stage cancer) before undergoing surgery.

Exclusion Criteria:

* Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR \< 30 ml/min).

Primary outcomes:
measure: Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer.
timeFrame: 2010-2014 continuously
Secondary outcomes:
measure: Reduction in toxicity related to the treatment
timeFrame: 2010-2014
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
References: