louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03000478: Virtual Reality Exposure Therapy for Combat
Official title: Virtual Reality Treatment for Combat Related PTSD: Is Virtual Azza More Effective Than Traditional Exposure Treatment?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 40
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: This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.

Detailed description: Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental effects, on the individual, such as mood disorders and alcohol abuse, on family members, and on society at large. Although effective treatments for PTSD exist, primarily types of cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of factors act as barriers to care. These include not having the time for therapy, no therapy being locally available, and general stigma about therapy. In military populations, this stigma includes worries about the attitudes of unit members and commanding officers. As a result, many combat veterans do not seek therapy. Recently, it has been suggested that providing therapy in non-conventional settings might overcome some of these barriers. Studies over the last decade have shown that using Virtual Reality is a potential option. Virtual reality is a computer based environment that allows the therapist complete control over its multimedia components. VR is easily adaptable to exposure based treatments, where patients gradually come into contact with feared situations. VR for PTSD following combat, terror and motor vehicle accidents have all shown to be effective treatments. The studies so far are few, involve a small number of patients, and have often not adhered to gold standards of controlled trials. In addition, VR for combat in Israel has never been developed or tested.

The current study is a randomized controlled trial, that will compare traditional face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will examine levels of PTSD and other disorders before treatment, immediately after treatment, and at 6 month follow up.

Eligibility criteria: Inclusion Criteria:

* combat related PTSD; Hebrew first language

Exclusion Criteria:

* suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,

Primary outcomes:
measure: PTSD symptoms
timeFrame: 6 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar Ilan University
Study officials:
References:
Clinical trial NCT06854978: R3THA Rehabilitation Feasibility and Usability Study
Official title: R3THA Rehabilitation Feasibility and Usability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 20
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 how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.


Eligibility criteria: Inclusion Criteria:

1. must be between the ages of 20 and 80
2. must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
3. must have internet access at home.
4. must be comfortable performing basic functions on a computer, such as browsing the internet.
5. must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.

Exclusion Criteria:

Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.

2) Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke

Primary outcomes:
measure: System Usability Survey
timeFrame: 5 weeks
measure: Exergame Questionnaire
timeFrame: 5 weeks
measure: Performance Survey
timeFrame: 5 weeks
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: 5 weeks
measure: Box and Blocks Test
timeFrame: 5 weeks
measure: Action Research Arm Test
timeFrame: 5 weeks
measure: Kinematic Assessment
timeFrame: 5 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment Test (MOCA)
timeFrame: 1 week
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Kiran Karunakaran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403478: Effects of Aquatic Exercise on Post-exercise Hypotension
Official title: Effects of Aquatic Exercise on Post-exercise Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Aging
Obesity
Keywords: Hemodynamics
Aquatic exercise
Elderly
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: University Center of Joao Pessoa - UNIPE
First posted: 2018-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial. The present study involves an acute and chronic intervention, which is a water-based exercise (one session: to acute intervention; 12-weeks of aquatic exercise program: to chronic intervention). The sample will be composed by elderly enrolled in university extension program titled "Hidroginastica na Terceira Idade" (Hydrogymnastics in aging). It will be evaluated the effects of water-based exercise on hemodynamics, self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity. The investigators hypothesized that an acute water-based exercise under different intensities promotes hemodynamics changes in elderly. In addition, the investigators hypothesized that 12-weeks of aquatic exercise may lead improvements in self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity in elderly.


Eligibility criteria: Inclusion Criteria:

* Elderly (60 years and over)
* Able to practice physical exercise in water
* Able to answer all questionnaires
* Non-smoker

Exclusion Criteria:

* Morbid obese
* Those who not complete all data collection procedures

Primary outcomes:
measure: Blood pressure
timeFrame: Entire day (an average of 24 hours).
measure: Blood pressure
timeFrame: Up to 1 hour post-exercise session
Secondary outcomes:
measure: Self-reported sleep quality
timeFrame: Approximately 15 minutes
measure: Depressive symptoms (Mental disorders)
timeFrame: Approximately 5 minutes
measure: Self-reported quality of life
timeFrame: Approximately 15 minutes
measure: Level of physical activity (BAECKE modified to elderly)
timeFrame: Approximately 5 minutes
measure: Functional Capacity
timeFrame: Approximately 35 minutes
Other outcomes:
Locations:
city: Joao Pessoa
country: Brazil
facility: Bruno Teixeira Barbosa
state: Paraíba
Study officials:
affiliation: University Center of Joao Pessoa - UNIPE
name: Bruno T Barbosa, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01756378: Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis
Official title: Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fittness
Keywords: Mobilization with movement,knee osteoarthritis,
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we tested the effect of adding the mobilization with movement to the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA.

study hypothesis: there will be no significant difference between traditional physical therapy program and the mobilization with movement plus the traditional physical therapy program on pain, ROM and functional disability in patients with knee OA


Eligibility criteria: Inclusion Criteria:

* patients with unilateral osteoarthritis knee age ranges from 30-60 years old grade 1 or 2 on Kallegren and Lawerance scale. body mass index not more than 36

Exclusion Criteria:

* history of major knee injury or surgery, tumors, osteoporosis, patients undertaking analgesics, patients with uncontrolled hypertension, bleeding, dermatological problems, psychiatric disorders, hearing problems, cognitive problems and pacemaker.

Primary outcomes:
measure: pain
timeFrame: baseline and up to 10 months
measure: functional disability
timeFrame: baseline and up to 10 months
measure: Range of motion for the knee joint
timeFrame: baseline and up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo University
Study officials:
affiliation: Faculty of Physical Therapy, Cairo Un iversity
name: Magdolin M Shenouda, Ph.D
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Reda K Gad ElHak, Ms.C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00686478: Intron A for the Treatment of Hypertrophic Scar
Official title: A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Burn
Hypertrophic Scar
Keywords: burn
hypertrophic scar
fibroproliferative disorder
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.

Detailed description: Burn patients being followed and treated in the Outpatient Burn Clinic with large areas of HTS are approached to participate in the study. Patients who agree to participate and who have signed an informed consent are entered into the trial.

Pre-treatment evaluation and monthly examinations include:

* standardized photographs of scar
* scar volume
* Vancouver Burn Scar Assessment (VBSA)
* blood work (TGF-beta, histamine)
* urine collection (histamine)
* 6mm punch biopsy of HTS and adjacent normal skin (every two months)

Patients are randomized to received with placebo or Intron A 1x106 IU a day for 7 days, then 3x106 IU 3 SC, three times a week for 23 weeks.

Eligibility criteria: Inclusion Criteria:

* burns \> 5% tbsa
* informed consent
* no prior exposure to interferon or other cytokines

Exclusion Criteria:

* history of cardiac or CNS disorder or disease
* autoimmune disease
* immunodeficiency
* abnormal renal or hepatic function
* pregnancy
* serious intercurrent illness
* active infection
* malnutrition
* active drug or alcohol abuse

Primary outcomes:
measure: Systemic effect of Intron A on hypertrophic scar
timeFrame: once / month for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Edward E Tredget, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06773078: Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial
Official title: Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Biomarkers of Intake, Urinary Biomarkers, Foodomics, Metabolom
Keywords: dietary assessment, nutrimetabolomics, avocado, corn tortilla, nopal, guava, mango, amaranth
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, open-label trial
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

Detailed description: A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

Participants will be randomized into three groups for the intake of meals containing the foods of interest and control without these foods. After the meal consumption including foods of interest, a 24-hour urine sample will be collected by the participants. Urine and blood samples will be analyzed using using untargeted metabolomics in different platforms to determine biomarker concentrations.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Body mass index (BMI ) between 18.5 to 30 kg/m2
* Not having allergies to the study foods (ataulfo mango, nopal, guava, avocado, corn tortilla and amaranth).
* Without consumption of dietary supplements at the time of participating in the study.
* Blood chemistry within reference values (glucose \<126 mg/dL, triglycerides \<250 mg/dL, total cholesterol \<250 mg/dL.

Exclusion Criteria:

* The exclusion criteria were participants with any other chronic disease diagnosed by any doctor.
* Were pregnant.
* Smoking habit durig the trial.
* Intake of alcoholic beverages during the trial.

Primary outcomes:
measure: Exploratory biomarkers of food intake
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
References:
Clinical trial NCT01710878: Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Official title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aorta Aneurysm
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

Detailed description: The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta.

The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.

Eligibility criteria: Inclusion Criteria:

Patient aged 18-85 years

Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft

Exclusion Criteria:

Patient treated as an emergency

Patient included in another investigation

Patient pregnant or lactating or woman of childbearing potential

Patient with a known allergy to the material device used (collagen, triclosan, silver)

Patient with previous aorto-iliac bypass or replacement

Primary outcomes:
measure: Primary Graft Patency
timeFrame: Up to 36 months
Secondary outcomes:
measure: Secondary endpoint - assessment of AEs
timeFrame: Up to 36 months
Other outcomes:
measure: Secondary endpoint - levels of silver and triclosan
timeFrame: Up to 30 days
Locations:
city: Angers
country: France
facility: CHRU
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nantes
country: France
facility: Hôpital G. et R. Laennec
city: Paris
country: France
facility: Hôpital Pompidou
city: Poitiers
country: France
facility: CHU La Milétrie
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
Study officials:
affiliation: CHU La Milétrie
name: Jean-Baptiste Ricco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05538078: Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
Official title: Clinical and Radiographic Evaluation of Non-Surgical Therapy With and Without Ozone Gel Application in Controlled Type 2 Diabetic Patients With Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The adjunctive topical subgingival application ozone gel creates a great improvements in the clinical, bacteriological and immunological parameters over the gold standard of periodontal pocket treatment alone.

Detailed description: The aim of this study is to compare the effect of using ozone gel as a locally delivered adjunct to scaling and root planning versus scaling and root planning alone on the clinical parameters in stageIII grade B in periodontitis patients with controlled diabetic patients.

Eligibility criteria: Inclusion Criteria:

1. Patient with controlled diabetic type II. (HgA1C \<7) (Mori et al., 2021)
2. Adult patients above 18 years old.
3. Patients with stage III and grade B periodontitis.
4. Patients accept 3-months follow-up period (cooperative patients).
5. Patients provide an informed consent

Exclusion Criteria:

* 1. Presence of prosthetic crowns. 2. Extensive restorations. 3. Periodontal therapy within the last 12 months. 4. Having surgical therapy or undergoing orthodontic treatment. 5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.

  6. The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 3 months of follow-up.

  7. Smokers. 8. Pregnant females. 9. Any known allergies

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 3months
Secondary outcomes:
measure: Probing Depth
timeFrame: 3 months
measure: plaque index
timeFrame: 3 months
measure: Dentinal Hypersensitivity
timeFrame: 7 days
measure: Bleeding on Probing visually/numerical data
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry ,Cairo university
state: Manial
Study officials:
affiliation: Master student
name: Abeer A Barahim, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
name: Nesma M Shemais, PhD
role: STUDY_DIRECTOR
affiliation: Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
name: Mona S Darhous, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01956578: REVEAL for Respiration Detection
Official title: REVEAL for Respiration Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unexplained Syncope
Suspected Arrhythmia
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in patients previously implanted with a Reveal for unexplained syncope or suspected arrhythmia.


Eligibility criteria: Inclusion Criteria:

* Subject is implanted with a Reveal ICM or Reveal XT ICM for unexplained syncope or suspected arrhythmia
* Subject (or the legal representative) is willing to sign informed consent form
* Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

* Significant respiratory diseases such as COPD or pulmonary hypertension.
* Patients with frequent arrhythmias, including PVC's.
* Patients with known heart failure.
* Body conditions that would complicate accurate measurement of respiratory rate with the respiration device.
* Patients which are not able to take the postures as necessary for the study protocol and which cannot walk continuously for a period of 6 minutes.
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control.
* Subject is enrolled in one or more concurrent studies that would confound the results of this study

Primary outcomes:
measure: Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing.
timeFrame: Up to 3 minutes
Secondary outcomes:
measure: Respiration rate obtained from the REVEAL ICM ECG with the respiratory rate obtained from external respiratory band during three minute periods of periodic, controlled breathing and elevated heart rate.
timeFrame: Up to 3 minutes
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: J. Bucx
role: PRINCIPAL_INVESTIGATOR
References: