louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04226677: The Effects of Video Based Training and Aerobic Exercise Training in Individuals With Internet Gaming Disorder
Official title: Investigation of the Effects of Video Based Training and Aerobic Exercise Training on Game Addiction Level and Functional Performance in Individuals With Internet Gaming Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gaming Disorder
Sedentary Behavior
Keywords: gaming disorder
aerobic exercise
exergame
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: participants are grouped randomly, the first group is the aerobic exercise group, the second group is the video based exercise group and the third group is the combination of these.
Primary purpose: TREATMENT

Brief summary: In this study, video-based training, aerobic training and both training will be applied to individuals with internet gaming disorder. Addiction levels and functional performance will be evaluated before and after treatment.

Detailed description: The aim of this study is to investigate the effect of game-based training and aerobic exercise training on game addiction level, functional performance and exercise capacity in individuals with internet play disorder. In addition, the investigators think that facilitate the transition to exercise by using game-based training in order to gain exercise habit and reduce sedentary behaviours in individuals with internet gaming disorder.

Eligibility criteria: Inclusion Criteria:

* DSM V (Diagnostic and Statistical Manual of Mental Disorders, revision 5) Internet Gaming Impairment (IOOB) Diagnostic criteria: approval of five to nine items
* No communication barrier
* Playing game (smart phone,Play Station 4, Xbox, Personal Computer) at least 2 hours a day in the last year

Exclusion Criteria:

* Cigarette use over 10 packsXyear
* be using any medicine
* Be actively involved in any sport.
* Having chronic disease
* Having physical disability

Primary outcomes:
measure: Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
timeFrame: 2 Monthly change
measure: The International Physical Activity Questionnaire (IPAQ)
timeFrame: 2 Monthly change
Secondary outcomes:
measure: Quality of Life Assessment: Short Form-36.
timeFrame: 2 Monthly change
measure: Anxiety Scale
timeFrame: 2 Monthly change
measure: Senior Fitness Test (SFT)
timeFrame: 2 Monthly change
measure: 20m-Shuttle Run Test
timeFrame: 2 Monthly change
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Universty
state: Şahinbey
Study officials:
affiliation: Hasan Kalyoncu University
name: Çağtay maden, MSc, Pt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092177: Virtual Reality Distraction in Patients Undergoing Periodontal Surgery
Official title: Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Oral Surgery
Dental Anxiety
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.

Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.


Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 18
* Systemically healthy patients
* Need for periodontal surgical treatment in the mandibular anterior region
* Scoring 15 or above on the modified dental anxiety scale

Exclusion Criteria:

* Having a history of seizures or a convulsive disorder
* Balance disorders such as nystagmus, vertigo
* Use of psychotropic drugs
* Getting treatment for anxiety
* Presence of dermatological lesions on the face, especially around the eyes
* A lesion in the eye that will prevent the use of virtual reality glasses
* Systemic disease and medication use that contraindicate periodontal surgery

Primary outcomes:
measure: Anxiety level
timeFrame: Preoperative, immediately postoperative
Secondary outcomes:
measure: Pain level
timeFrame: Preoperative, immediately postoperative
measure: Systolic blood pressure
timeFrame: Preoperative, intraoperative, immediately postoperative
measure: Diastolic blood pressure
timeFrame: Preoperative, intraoperative, immediately postoperative
measure: Heart rate
timeFrame: Preoperative, intraoperative, immediately postoperative
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Ezgi Gurbuz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123277: Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
Official title: Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Disorder
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 31
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 study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

Detailed description: The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.

This patients are refractory to the reference medical treatment.

Eligibility criteria: Inclusion Criteria:

* patients between 20 and 80 years old
* tubal score lower than 5
* patients who already used reference medical treatment

Exclusion Criteria:

* patients who already do a major surgery of middle ear
* tympanic perforation
* pregnant or breastfeeding woman.
* patients who can't be follow during 14 months

Primary outcomes:
measure: Change in Tubal score
timeFrame: at 1st day, and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
Study officials:
affiliation: CHRU Montpellier
name: Frederic VENAIL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaderbay A, Karkas A, Schmitt D, Mura T, Lavieille JP, Venail F. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.
Clinical trial NCT01952977: Effect of Medium Chain Triglyceride Consumption on Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 17
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to test the effects of medium chain triglyceride consumption, relative to long chain triglycerides, on hormones involved in appetite regulation and food intake in overweight men. We expect medium chain triglycerides to reduce appetite and food intake and to do so by increasing levels of hormones known to be involved in satiety and reduce levels of those involved in appetite.


Eligibility criteria: Inclusion Criteria:

* Males
* Weight stable (\<10 lb over previous 3 months)
* Overweight (body mass index 25-29.9)

Exclusion Criteria:

* Smokers
* Excessive caffeine users
* Severe health conditions
* Allergy to food products/ingredients in the study
* Taking medications known to affect energy expenditure or gastrointestinal function

Primary outcomes:
measure: Food intake
timeFrame: up to 3 hours
Secondary outcomes:
measure: Ghrelin
timeFrame: 3 hours
measure: Peptide YY
timeFrame: 3 hours
measure: Glucagon-like peptide 1
timeFrame: 3 hours
measure: Insulin
timeFrame: 3 hours
measure: Triglycerides
timeFrame: 3 hours
measure: Leptin
timeFrame: 3 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Obesity Nutrition Research Center
state: New York
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Marie-Pierre St-Onge, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: St-Onge MP, Mayrsohn B, O'Keeffe M, Kissileff HR, Choudhury AR, Laferrere B. Impact of medium and long chain triglycerides consumption on appetite and food intake in overweight men. Eur J Clin Nutr. 2014 Oct;68(10):1134-40. doi: 10.1038/ejcn.2014.145. Epub 2014 Jul 30.
Clinical trial NCT00241098: The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
Official title: A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Congestive Heart Failure
Keywords: HYPERTENSION
HEART FAILURE
PEPTIDE
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.


Eligibility criteria: Inclusion Criteria:

* Male or female 25-85 years of age, inclusive
* Past diagnosis of hypertension for a min 1 year
* Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months
* BP is considered adequately controlled with DBP \< 90mmHg
* Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory
* LV ejection fraction ³ 45%
* LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females
* At least one of the following parameters of diastolic dysfunction

  * E/A \< 1 for the patients who are younger than 55 years or \< 0.8 for the patients whose age is ³ 55 years (full year), or
  * DT \> 220 ms, or
  * IVRT \> 90 ms

Exclusion Criteria:

• Present use of ACE inhibitor

Other protocol-defined exclusion criteria may apply.

-

Primary outcomes:
measure: Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary outcomes:
measure: Change from baseline in a blood measurement for heart failure after 12 weeks
measure: Change in baseline heart size after 26 weeks
measure: Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
measure: Change from baseline in markers of heart fibrosis after 26 weeks
measure: Change from baseline quality of life questionnaire after 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04467398: Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks
Official title: Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks and Impact of Needle Types to the IV Uptake: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trigeminal Neuralgia
Facial Pain
Postherpetic Neuralgia
Cluster Headache
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who scheduled to undergo trigeminal nerve block because of:

1. Trigeminal neuralgia/neuropathy
2. Postherpetic trigeminal neuralgia
3. Atypical facial pain
4. Cluster headache

Brief summary: The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.

Detailed description: The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1 ratio to tuohy needle group or quincke needle group after being informed about the study.

Eligibility criteria: Inclusion Criteria:

* The patients who scheduled to undergo trigeminal nerve block due to the facial pain

Exclusion Criteria:

* Refusal of the patient
* Pregnancy
* Coagulopathy
* Local or systemic infection
* Allergy to injectate
* Anatomical deformation of the skull

Primary outcomes:
measure: IV uptake prevalence (%)
timeFrame: During the procedure
Secondary outcomes:
measure: Difference in incidence of intravascular injection
timeFrame: During the procedure
measure: Total incidence of blood aspiration
timeFrame: During the procedure
measure: Total incidence of intravascular injection
timeFrame: During the procedure
measure: The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.
timeFrame: During the procedure
measure: The number of needle adjustment.
timeFrame: During the procedure
measure: Total volume of local anesthetics for skin anesthesia.
timeFrame: During the procedure
measure: Time for the procedure.
timeFrame: During the procedure
measure: Total amount of radiation exposure for the procedure.
timeFrame: During the procedure
measure: Laterality
timeFrame: During the procedure
measure: Final pattern of the fluoroscopic image
timeFrame: During the procedure
measure: Post-procedure pain
timeFrame: Within 1 hour after the procedure.
measure: The difficulty of the procedure
timeFrame: Within 1 hour after the procedure.
measure: The difference in incidence of blood aspiration
timeFrame: During the procedure.
measure: The difference in incidence of intravascular injection.
timeFrame: During the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05615298: Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
Official title: Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Lunit Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Screenign Mammography Population

Brief summary: This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.

Detailed description: The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.

Eligibility criteria: Inclusion Criteria:

* Female
* Any ethnic origin
* Acquired with devices from two manufacturers: Hologic and GE
* 4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)

Exclusion Criteria:

* Previous core needle biopsy in breast for past 2 years
* Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
* Previous breast cancer
* Lactating when taking screening mammograms
* Presence of a breast implant in screening mammograms
* Presence of a pacemaker in screening mammograms
* Inadequate quality status such as insufficient anatomical coverage of screening mammograms

Primary outcomes:
measure: Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Atrius Health
state: Massachusetts
Study officials:
affiliation: Atrius Health
name: Gregg Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05472298: Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
Official title: The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: self-management intervention
metabolic syndrome
women
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2022-07-25
Enrollment: 137
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to assess the efficacy of multidimensional self-management intervention program on metabolic syndrome subjects in Taiwan.

Detailed description: The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) \>150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol\<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (6th months and 18th months). All participants complete a structured questionnaire, including basic information, physical activity, and food-frequency.

Eligibility criteria: Inclusion Criteria:

* adult women with age ≥ 50 years
* low education, defined as having less than 6 years of education or being primary school graduates
* presence of metabolic syndrome
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia

Primary outcomes:
measure: metabolic syndrome
timeFrame: 6 month, and 18-month follow up
Secondary outcomes:
measure: body weight
timeFrame: 6 months, and 18 months follow up
measure: BMI
timeFrame: 6 months, and 18 months follow up
Other outcomes:
measure: leisure-time physical activity
timeFrame: 6 months, and 18 months follow up
measure: dietary behaviors
timeFrame: 6 months, and 18 months follow up
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Shu-Hung Chang, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463798: Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
Official title: Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragmatic Paralysis
Healthy Volunteers
Keywords: structured light plethysmography
sonar
transdiaphragmatic pressure
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.

Brief summary: this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.

Detailed description: The measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using SLP and Sonar devices.

Subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. The SLP and the Sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. Data will be collected during 5 minutes of tidal breathing. The same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. During both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (IC) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.

Eligibility criteria: FOR HEALTHY VOLUNTEERS

Inclusion Criteria:

* no respiratory disease
* no neurologic disease
* no thoracic deformation

Exclusion criteria

* respiratory disease
* neurologic disease
* thoracic deformation

FOR PATIENTS

Inclusion Criteria:

* patients with a suspicion of diaphragmatic dysfunction

Exclusion Criteria:

* pregnant women
* contraindications to standard procedure requiring transdiaphragmatic measurement

Primary outcomes:
measure: amplitude of displacement of thoraco-abdominal compartments
timeFrame: 10 minutes
Secondary outcomes:
measure: displacement speed of thoraco-abdominal compartments
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: UMRS_1158
name: Pierantonio LAVENEZIANA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: