louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06255119: The Feasibility of VR for OUD
Official title: The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: mood
cravings
retention
Lead sponsor: 3D Therapy, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.

Detailed description: The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.

Eligibility criteria: Inclusion Criteria

1.18 years or older

2. Current diagnosis of opioid use disorder

3. Current inpatient in detox ATS unit

4. Fluent in English

Exclusion Criteria

1. Active suicidality
2. History of seizures
3. History of psychosis
4. Severe visual impairment

Primary outcomes:
measure: Retention in Treatment
timeFrame: At departure from facility, through study completion, an average of 10 days
measure: Feasibility and Tolerability of 3DTT
timeFrame: Immediately after each treatment
Secondary outcomes:
measure: Mood
timeFrame: Before and after each treatment, approximately every other day for up to 5 days
measure: Anxiety
timeFrame: Before and after each treatment, approximately every other day for up to 5 days
measure: Cravings
timeFrame: Before and after each treatment, approximately every other day for up to 5 days
Other outcomes:
Locations:
city: Quincy
country: United States
facility: The Gavin Foundation
state: Massachusetts
Study officials:
References:
Clinical trial NCT00761319: Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
Official title: An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 705
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 purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
* Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
* Best corrected visual acuity of -0.6 logMAR or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
* Use of contact lenses within 30 days of Visit 1.
* Use of contact lenses during the study.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
timeFrame: Day 0, Day 90
Secondary outcomes:
measure: Percentage of Patients With Corneal Fluorescein Staining Score = 0
timeFrame: Day 90
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01150019: Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) (18FDG-PET)
Official title: Correlation Between Circulating Resistin and Vascular Inflammation Measured by 18FDG-PET in Obese Person
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: atherosclerosis
vascular inflammation
resistin
adiponectin
18FDG-PET
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participats who underwent a medical health check in the health promotion center in Korea Guro University

Brief summary: Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis.Resistin was shown to induce vascular endothelial dysfunction and vascular smooth muscle cell proliferation.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between circulating resistin and vascular inflammation detected by 18FDG-PET in obese persons.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
* Diabetes
* Hypertension
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as non-steroidal anti-inflammatory drugs (NSAIDs) and statin

Primary outcomes:
measure: Vascular inflammation in carotid arterial wall represented as the target-to-background ratio (TBR) using FDG-PET
timeFrame: 12 weeks
Secondary outcomes:
measure: Circulating serum adiponectin levels
timeFrame: 12 weeks
measure: carotid intima-media thickness levels measured using ultrasonography
timeFrame: 12 weeks
measure: Circulating serum resistin levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hae Yoon Choi
Study officials:
affiliation: Korea University
name: Kyung Mook Choi, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00529919: Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss
Official title: The Effects of a Weight Loss Diet Containing Medium Chain Triglyceride Oil, Versus Olive Oil, on Body Composition in Free-Living Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Overweight
Obesity
Weight loss
Medium chain triglycerides
Cardiovascular disease risk
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: International Life Sciences Institute
First posted: 2007-09-14
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.


Eligibility criteria: Inclusion Criteria:

* body mass index 27-33 kg/m2
* pre-menopausal women
* weight stable for at least 6 months
* normal score on Brief Symptoms Inventory questionnaire

Exclusion Criteria:

* chronic disease
* weight loss treatment
* medication known to affect body weight
* unstable blood pressure, glucose, lipid levels

Primary outcomes:
measure: Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in blood pressure, change in fat-free mass
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Marie-Pierre St-Onge, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: St-Onge MP, Bosarge A, Goree LL, Darnell B. Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil. J Am Coll Nutr. 2008 Oct;27(5):547-52. doi: 10.1080/07315724.2008.10719737.
Clinical trial NCT05719519: Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
Official title: Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: 3D imaging
gingiva
nonsurgical periodontal debridement
periodontitis
quality of life
smoking
Lead sponsor: University of Rijeka
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the dimensional changes of the gingiva due to initial periodontal therapy in non-smokers and cigarette smokers and to compare the oral health related quality of life of non-smokers and cigarette smokers with periodontitis before and after initial periodontal therapy. Changes in gingival volume are expected to be greater in non-smokers than in cigarette smokers. It is expected that the quality of life will be better after therapy in both groups, with better results in the non-smoking group.

60 subjects with periodontitis will be included in the study 30 non-smokers and 30 cigarette smokers. All subjects will fill out a quality of life questionnaire which will be validated before the onset of this research. This will be followed by clinical periodontal examination. After examination, the upper and lower jaw will be scanned using an intraoral scanner and initial periodontal therapy will be performed. After 8 weeks, subjects will fill out the quality of life questionnaire again, measurement of periodontal indices and scanning will be performed. The digital scans wll be superimposed, and the dimensional changes of the gingiva will be quantified and compared between the two groups. By using 3D technology, it will be possible to objectively quantify tissue changes and monitor the course of the disease. A 3D comparison between non-smokers and cigarette smokers will provide a new perspective on the relationship between smoking and periodontitis. Furthermore, it will be demonstrated to what extent smoking affects the quality of life of patients with periodontitis and the results of non-surgical therapy.


Eligibility criteria: Inclusion Criteria:

* periodontitis
* cigarette smokers
* non smokers

Exclusion Criteria:

* previous periodontal treatment
* pregnancy
* minors
* antibiotic therapy in the last 6 months
* patients with ortho appliances
* patients using drugs that affect gingival volume
* immunosuppressive therapy
* systemic conditions that affects periodontal tissues and therapy

Primary outcomes:
measure: Volume changes
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Faculty of Dental Medicine
Study officials:
References:
Clinical trial NCT05945719: Discrimination Harassment of Pain Staff Caused by Patient
Official title: Discrimination and Harassment of Pain Clinic Staff Caused by Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abuse, Sexual
Abuse, Workplace
Keywords: Harassment by patients
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult chronic pain patients who are undergoing treatment in a specialist pain clinic

Brief summary: Chronic pain is associated with mental disorders, and some patients have behavioral issues. Some patients may sexually or racially harass pain clinic staff. Healthcare staff do not usually report sexual or racial harassment perpetrated by patients.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of sexual and racial harassment of clinic staff; perpetrated by patients. Analysis of causative factors, incident outcome, system factors and lessons learned.

Detailed description: Chronic pain disorder may be associated with mental health disease. Many patients exhibit behavioral problems. Some of the patients may sexually or racially harass the pain clinic staff. Typically, healthcare providers do not report racial or sexual harassment perpetrated by patients.

This is a quantitative analysis of prospective electronic and clinic diary data. It evaluates many incidents of sexual and racial harassment of pain clinic staff; perpetrated by patients. It analyzes the incident causative factors, incident outcomes, system factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Eligibility criteria: Inclusion Criteria:

* adult chronic pain patients

Exclusion Criteria:

* pediatric chronic pain patients

Primary outcomes:
measure: Percentage of patients who sexually or racially harassed clinic staff
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adler M, Vincent-Hoper S, Vaupel C, Gregersen S, Schablon A, Nienhaus A. Sexual Harassment by Patients, Clients, and Residents: Investigating Its Prevalence, Frequency and Associations with Impaired Well-Being among Social and Healthcare Workers in Germany. Int J Environ Res Public Health. 2021 May 13;18(10):5198. doi: 10.3390/ijerph18105198.
Clinical trial NCT04765319: Delivery Considerations of Cognitive Processing Therapy for PTSD
Official title: Delivery Considerations of Cognitive Processing Therapy for PTSD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Lead sponsor: VA Salt Lake City Health Care System
Sponsor class: FED
First posted: 2021-02-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans seeking treatment for PTSD at VA outpatient specialty clinic.

Brief summary: Review treatment outcomes of modifications to standard delivery of CPT for PTSD that are delivered as routine care at in VA outpatient clinic.

Detailed description: Background and Introduction Cognitive Processing Therapy (CPT) is an evidenced based psychotherapy for PTSD. It is considered a first line treatment and has ample evidence supporting it's effectiveness (ISTSS and VA/DOD clinical practice guidelines). This therapy is manualized and a framework is provided to ensure consistent delivery. Additionally, the VA Office of Mental Health Operations sponsors training and dissemination of CPT throughout the VA system and the PI of this study is a trainer and consultant of this therapy. Flexibility exists in the protocol and CPT can be delivered in unorthodox modalities such as telehealth (Moreland et al, 2015) and on compressed time schedules (Held et al, 2020; Bryan et al, 2018). While the literature supports the effectiveness of these interventions in unique settings, no known studies have looked at outcome data of real-world outpatient clinics. The PTSD Clinical Team provides CPT as part of it's standard care with a variety of adaptations. The team practices measurement based care and routinely collects self-report symptom inventories to track patient progress. This study aims to use data collected as part of standard care in this clinic to evaluate the effectiveness of these treatment adaptations in this setting.

Purpose and Objectives The purpose of this study is to explore the impact of how CPT for PTSD is delivered. Initial areas of review will include in person vs. telehealth delivery and timing (daily vs. weekly).

Eligibility criteria: Inclusion Criteria:

* PTSD diagnosis
* Veterans eligible for VA care
* Treatment seeking Veterans

Exclusion Criteria:

* PTSD not priority of treatment due to comorbidity, safety, etc. All patients that would be treated for PTSD in outpatient clinic are included.

Primary outcomes:
measure: PTSD Checklist 5
timeFrame: Through study completion, an average of 12 sessions (3 months)
Secondary outcomes:
measure: PHQ-9
timeFrame: Through study completion, an average of 12 sessions (3 months)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Salt Lake City VAMC
state: Utah
Study officials:
affiliation: VA Salt Lake City
name: Harrison R Weinstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213719: Effects of Betaine Supplementation on Strength and Muscle Creatine Content
Official title: Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: betaine, creatine, strength
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.


Eligibility criteria: Inclusion Criteria:

* physically inactive
* non-obese

Exclusion Criteria:

* skeletal muscle disturbance
* cardiovascular disturbance
* use of dietary supplements

Primary outcomes:
measure: strength
timeFrame: after 10 days
Secondary outcomes:
measure: intramuscular creatine content
timeFrame: after 10 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05312619: The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey
Official title: The Burden of Lyme Disease (BOLD) in a Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lyme Disease
COVID-19 Vaccine
Lead sponsor: Dr. Daniel Cameron & Associates
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not.

Brief summary: A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

Detailed description: Primary research question:

1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?

Secondary research questions:

1. Will the BOLD be worse for individuals who have been ill with COVID-19?
2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?

Eligibility criteria: Inclusion Criteria:

* ≥12 years old
* a self-report of having been diagnosed with Lyme disease.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)
timeFrame: 7/21 to 7/23
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Kisco
country: United States
facility: Daniel Cameron
state: New York
Study officials:
References: