louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06655753: Craniocervical Dysfunction Index in Patients With Temporomandibular Joint Dysfunction
Official title: Turkish Validity and Reliability of the Craniocervical Dysfunction Index in Patients Temporomandibular Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Temporomandibular Joint Dysfunction
Craniocervical Dysfunction
Reliability
Validity
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: aproximately 5o patients with temporomandibular joint dysfunction between the ages of 20-60 years

Brief summary: The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with Temporomandibular Joint Dysfunction, reliability and validity of the index Turkish speaking adults.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 20-60 years
* Clinical diagnosis of non-specific neck pain
* Being able to communicate in Turkish
* Volunteering to participate in the study

Exclusion Criteria:

* Over 60 years of age
* Those with impairments in cervical mobility that affected the postural assessment

Primary outcomes:
measure: Craniocervical Dysfunction Index
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaaddin Keykubat Üniversity
state: Alanya
Study officials:
References:
Clinical trial NCT05044351: Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
Official title: Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autofluorescence
Thyroidectomy
Autotransplantation
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: PREVENTION

Brief summary: Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:

Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.

Detailed description: Patients referred for hemithyroidectomy will be randomized to either:

(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.

Eligibility criteria: Inclusion Criteria:

* Patients referred for thyroid lobectomy
* Age \> 18
* Able to understand patient information
* Able to give informed consent

Exclusion Criteria:

* Completion lobectomy
* Need for accelerated surgery
* Age \< 18
* Unable to understand patient information
* Unable to give informed consent

Primary outcomes:
measure: Parathyroid gland identification rate
timeFrame: Will be assessed at the time of surgery
Secondary outcomes:
measure: Rate of inadvertent parathyroid excision
timeFrame: Will be assessed one month following surgery
measure: Rate of autotransplantation
timeFrame: Will be assessed at the time of surgery
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Otorhinolaryngology, Regional Hospital West Jutland
Study officials:
References:
Clinical trial NCT04350151: National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents
Official title: National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Professional
Intensive Care
Anesthesia
Depression, Anxiety
Stress, Psychological
Fatigue
Work Load
Lead sponsor: Facteurs Humains en Santé
Sponsor class: OTHER
Collaborators: name: Dominique FLETCHER MD-PhD
name: François Marty MD
name: Dinh Phong Nguyen MD
name: Loic Druette MD
name: Benoit Plaud MD-PhD
name: Clément Duret MD
First posted: 2020-04-16
Enrollment: 519
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French resident of intensive care and anesthesia

Brief summary: Psychological distress is a significant problem for healthcare professionals and students in training. The investigator question the prevalence of this problem in French residents in anaesthesia and intensive care training.

Detailed description: The investigator performed an observational study on the national population of anaesthesia residents. A questionnaire was sent to all residents composed with validated questionnaires analyzing psychological distress (Hospital Anxiety and Depression Scale (HADS), Copenhagen Burnout Inventory (CBI), Perceived Stress Scale (PSS), Karasek's questionnaire; work-related questions (work hours per week, night shift per month, application of safety rest after night shift, average time to start and end work, break time and time for food per day; two semi-open work-related questions (main stressor during internship, professional orientation); a free verbatim.

Eligibility criteria: Inclusion Criteria:

* resident of intensive care or anesthesia, french

Exclusion Criteria:

* none

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Copenhagen Burnout Inventory (CBI)
timeFrame: baseline
measure: Karacek's questionnaire
timeFrame: baseline
measure: Perceived Stress Scale (PSS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
measure: Workload
timeFrame: baseline
measure: Gender
timeFrame: baseline
Locations:
city: Paris
country: France
facility: Facteurs Humains en Santé
state: Ile De France
Study officials:
References:
Clinical trial NCT04710251: Effectiveness of Using the Speedometer During Colonoscopy
Official title: Effectiveness of Using the Speedometer During Colonoscopy: a Prospective, Comparative Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Colonic Adenoma
Adenoma Colon
Keywords: Colonoscopy
Adenoma detection rate
Withdrawal time
Artificial Intelligence
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
Collaborators: name: Beth Israel Deaconess Medical Center
name: Oslo University Hospital
name: University of Oslo
name: Showa University
First posted: 2021-01-14
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: PURPOSE OF PROTOCOL

Objective:

To evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy.

Hypothesis:

The trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. Our objective is to clarify the clinical benefits of this digital tool in colonoscopy.

Endpoint: Withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).


Eligibility criteria: Inclusion Criteria:

* Both women and men aged 18 years or older undergoing colonoscopy for any indication at Beth Israel Deaconess Medical Center (BIDMC), Boston, USA.

Exclusion Criteria:

* Known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.

Primary outcomes:
measure: Withdrawal time
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: Through study completion, an average of 1 year
measure: Quality of colonoscopy
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03277651: Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension
Official title: Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
Cirrhosis
Portal Hypertension
Keywords: noninvasive
Hemodynamics
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan hospital Fudan University

Brief summary: This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

Detailed description: As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.

Eligibility criteria: Inclusion Criteria:

* Inpatients who undergo liver biopsy or hepatic venous pressure gradient test

Exclusion Criteria:

* decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy);
* alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 × upper limit of normal (ULN);
* any malignant tumor;
* any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases;
* severe neurological or psychological disease;
* pregnant or lactating women.

Primary outcomes:
measure: Sensitivity
timeFrame: baseline
measure: Specificity
timeFrame: baseline
measure: Positive predictive value (PPV)
timeFrame: baseline
measure: Negative predictive value (NPV)
timeFrame: baseline
measure: Area under ROC curve (AUROC)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Wei Jiang
role: STUDY_CHAIR
References:
Clinical trial NCT03900351: Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Official title: Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Proprioceptive Disorders
Balance; Distorted
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2019-04-03
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two group of subjects:

1. Group A (study group).
2. Group B:(Control group).
Primary purpose: TREATMENT

Brief summary: Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Subjects will be randomly assigned to Group A is the study group and Group B is the control group.

Detailed description: Group A will receive the Wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. Group B will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session.

A Universal Weight and Height Scale: will be used to measure the patient's BMI.

Biodex Isokinetic Dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees).

Eligibility criteria: Inclusion Criteria:

1. patients who will be in the early postoperative phase (week 2 after surgery)
2. patients with BMI less than 25, and more than 20.

Exclusion Criteria:

1. Patients with injury or operation accompanied by the ACLR as meniscectomy.
2. Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.

Primary outcomes:
measure: knee proprioception at 30 degrees
timeFrame: 3 minutes
measure: knee proprioception at 45 degrees
timeFrame: 3 minutes
measure: knee proprioception at 60 degrees
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gizan
country: Saudi Arabia
facility: Jazan University
state: Jazan
Study officials:
References:
Clinical trial NCT00823251: IlluminOss Hand Fracture International Clinical Feasibility Study
Official title: IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Orthopedic Fractures
Lead sponsor: IlluminOss Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.


Eligibility criteria: Inclusion Criteria:

* Skeletally mature
* Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
* Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
* Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
* Fracture has occurred within past 3 weeks
* Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site

Exclusion Criteria:

* Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
* Patient has experienced a crush, mangling, or burn type injury
* Patient has probable history of infection or confirmed infection at baseline
* Patient has previous diagnosis of a significant bone disorder that may impair bone healing
* Patient has a life expectancy of \< 26 weeks
* Pathological fracture secondary to tumor
* Open fracture of Gustilo-Anderson Type II or III

Primary outcomes:
measure: Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
timeFrame: Immediately post-surgery
Secondary outcomes:
measure: Rate of Fracture Union
timeFrame: 180 day
measure: Rate of Anatomic Alignment
timeFrame: 180 Day
measure: Functionality Score
timeFrame: 180 Day
measure: Grip Strength
timeFrame: 180 Day
measure: Range of Motion
timeFrame: 180 day
measure: Incidence of Reintervention of Target Fracture
timeFrame: 180 Day
measure: Bone Pin Migration
timeFrame: 180 Day
measure: Adverse Event Rate
timeFrame: 180 day
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital del Trabajador
Study officials:
References:
Clinical trial NCT05604651: Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease
Official title: Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Keywords: Dry Eye Disease
Mucin
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Video display terminals users with and without dry eye disease.

Brief summary: The study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.

Detailed description: The cross-sectional study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.

Eligibility criteria: Inclusion Criteria:

* Participants who exposed to video display terminals for more than 1 year (at least 5 days per week and 6 hours per day) were enrolled and divided into two groups: (1) VDT users with DED and (2) VDT users without DED. DED was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \<10 sec; abnormal ocular surface staining (\>5 corneal spots or \> 9 conjunctival spots).

Exclusion Criteria:

* a history of contact lens wear or ocular surgery within 2 year of the study visit; a history of previous ocular disease; topical or systemic therapies other than artificial tears within two weeks before recruitment; and inflammatory ocular diseases, ocular surface diseases, glaucoma and systemic diseases with ocular involvement, such as meibomian gland dysfunction, diabetes, and peripheral neuropathy.

Primary outcomes:
measure: mucin expression
timeFrame: immediately after meeting the inclusion and exclusion criteria
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05563051: Kaneka Endovascular Embolization and Protection
Official title: Kaneka Endovascular Embolization and Protection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneurysm Cerebral
Keywords: aneurysm
coil
i-ED COIL
embolization
neuro endovascular
Lead sponsor: Kaneka Medical America LLC
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Detailed description: Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)

Study Duration

Anticipated timeline for study:

Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Eligibility criteria: Inclusion Criteria:

* Target aneurysm of 4mm - 14mm in size
* Ruptured or unruptured
* Suitable for embolization with coils
* May be treated with or without assist devices

Exclusion Criteria:

* Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
* Pre-planned staged procedure of target aneurysm
* mRS score 3 or more
* Hunt Hess Score more than 3 for subjects with ruptured aneurysm
* Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)

Primary outcomes:
measure: Adequate Occlusion
timeFrame: 12 months
Secondary outcomes:
measure: Complete Occlusion
timeFrame: 12 months
measure: Packing Density
timeFrame: 12 months
measure: Modified Rankin Score
timeFrame: 12 months
measure: Retreatment
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: McLaren Health Care
state: Michigan
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: SSM Health St. Anthony's Hospital
state: Oklahoma
Study officials:
affiliation: University of Massachusetts, Worcester
name: Ajit Puri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Mohamed Hussain, MD
role: PRINCIPAL_INVESTIGATOR
References: