louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04166851: Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
Official title: Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Pre-exposure prophylaxis
Health Promotion
HIV/AIDS primary prevention
men who have sex with men
Neuroimaging
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-11-18
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (PrEP) promotion messages for men who have sex with men (MSM) at risk of HIV in Baltimore.

Detailed description: This study will examine the utility of neuroimaging technique to evaluate PrEP promotion messages for MSM at risk of HIV in Baltimore. The investigators hypothesize that participants viewing top messages developed via open contests will show higher brain activation in the Medial Prefrontal Cortex (MPFC) regions than those viewing messages developed by a social marketing approach. The investigators further hypothesize brain activation in the MPFC regions is significantly more correlated with PrEP behavioral intention, initiation, and action than self-reported message effectiveness.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Biological male sex at birth
* Sexually active with men in the past 6 months
* Never taken PrEP
* HIV negative
* Reside in Baltimore City or surrounding counties
* Meet one of the criteria for being an appropriate PrEP candidate (i.e. in a relationship with a partner not known to be HIV-negative; are in a nonmonogamous relationship; have had any condomless anal sex with a casual male partner regardless of status in the prior 6 months; or had a positive sexual transmitted infection (STI) diagnosis within the prior 6 months).

Exclusion Criteria:

- Participated in open contest

Primary outcomes:
measure: Change of Willingness to Take PrEP
timeFrame: baseline, 30 days post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Cui Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496951: Vagal Tone and Neonatal Abstinence Syndrome
Official title: Vagal Tone and Neonatal Abstinence Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Abstinence Syndrome
Vagal Tone
Keywords: Neonatal abstinence syndrome
Methadone
Vagal tone
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-06
Enrollment: 65
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Drug exposed infants

Brief summary: Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available measure of autonomic nervous system functioning. NAS is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of NAS, only approximately ½ have severe enough symptoms to require pharmacologic therapy. This research seeks to determine the relationship between infant vagal tone and NAS severity. The determination of a link between newborn vagal tone and NAS severity could result in the prediction of infants at risk for severe NAS and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of NAS in the infant.

Detailed description: Consecutively born methadone exposed infants had hert period and cardiac vagal tone measurements extracted via standard EKGs on days 1 and 3 of life. The infant's NAS course was assessed serially.

Eligibility criteria: Inclusion Criteria:

* Term infant (\>= 37 weeks by 1st or second trimester sonogram),
* In utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth
* Delivery to a client active in drug abuse treatment

Exclusion Criteria:

* Significant medical complications in the infant
* Circumcision within 24 hours of the proposed EKG/vagal tone measurement (circumcision has been found to affect vagal tone)
* Infant hospitalization in the Neonatal Intensive Care Unit (NICU)
* Psychiatric impairment of the mother such that informed consent is not possible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren M Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansson LM, Dipietro JA, Elko A, Velez M. Infant autonomic functioning and neonatal abstinence syndrome. Drug Alcohol Depend. 2010 Jun 1;109(1-3):198-204. doi: 10.1016/j.drugalcdep.2010.01.004. Epub 2010 Mar 1.
Clinical trial NCT06980051: Virtual Windows in a Windowless Classroom
Official title: The Impact of Virtual Windows on Teachers in Windowless Classrooms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mood
Keywords: light
mood
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teachers at The Inspired Community Project, Bronx NY

Brief summary: The investigators are testing whether the use of virtual windows in a windowless classroom environment improves mood among teachers.

Detailed description: Teachers at The Inspired Community Project in the Bronx NY will be exposed to the virtual windows three days per week and the windows will be turned off two days per week. This will last for up to three months. Mood will be tracked.

Eligibility criteria: Inclusion Criteria:

* Teacher at The Inspired Community Project, Bronx NY

Exclusion Criteria:

* None

Primary outcomes:
measure: Mood
timeFrame: From enrollment until the end of three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00476151: A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Neuralgia
Keywords: DPN
Diabetic
Nerve Pain
Lead sponsor: EpiCept Corporation
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 226
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: This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

Detailed description: This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

Eligibility criteria: Inclusion Criteria:

* Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of \> 4 during the baseline week.

Exclusion Criteria:

* Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study

Primary outcomes:
measure: Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
timeFrame: baseline and 4 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Multiple Centers
Study officials:
affiliation: University of Rochester
name: Robert H Dworkin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05690451: Non-contrast Abbreviated MRI for Secondary Surveillance of HCC
Official title: The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Secondary surveillance of hepatocellular carcinoma
Contrast enhanced liver CT
non-contrast abbreviated MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.

Brief summary: This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Detailed description: This study was designed as a prospective single-arm intra-individual comparison multicenter study

Eligibility criteria: Inclusion Criteria:

* Age between 20-year old and 85-year old
* Patients with a history of curative treatment for HCC including surgical resection or local ablation
* No recurrence after curative treatment of HCC for more than two years
* Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion Criteria:

* Estimated GFR less than 60
* Previous history of severe allergic reaction to the iodinated contrast agent
* Patients with claustrophobia who can't undergo MR examination
* Patients having cochlear implants or cardiac pacemaker

Primary outcomes:
measure: Accuracy per patient
timeFrame: Within 6 months from the study completion
Secondary outcomes:
measure: Specificity per patient
timeFrame: Within 6 months from the study completion
measure: Sensitivity per patient
timeFrame: Within 6 months from the study completion
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Korea (the Republic Of)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea (the Republic Of)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Dong Ho Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720551: Calibration and Validation of the STISIM Driving Simulator
Official title: Calibration and Validation of the STISIM Driving Simulator: Simulated Driving Performance Under the Influence of Alcohol (0.05%, 0.08% AND 0.11%), and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulated Driving Performance
Keywords: STISIM
Alcohol
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.


Eligibility criteria: Inclusion Criteria:

* 21-50 years old
* Written informed consent
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
* No current or past drug use
* Possession of a driver's license for at least 3 years
* Be considered as reliable and mentally capable of adhering to the protocol

Exclusion Criteria:

* Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
* Positive urine pregnancy screen in women
* Present use of psychoactive medication
* Positive alcohol breath test
* Prior enrollment in the same study
* Physical or mental illness
* Excessive alcohol use ( \> 21 alcoholic drinks per week)
* Excessive smoking (more than 10 cigarettes per day)
* Intake of caffeine-containing beverages over 5 glasses per day
* Simulator sickness, as determined during the training session

Primary outcomes:
measure: Standard Deviation of the Lateral Position (SDLP)
timeFrame: one day
Secondary outcomes:
measure: Number of collisions and traffic violations
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University, Section Psychopharmacology
Study officials:
affiliation: Utrecht University
name: Joris C Verster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utrecht University
name: Lieke M de Senerpont Domis, MSc
role: STUDY_DIRECTOR
References:
citation: Mets MA, Kuipers E, de Senerpont Domis LM, Leenders M, Olivier B, Verster JC. Effects of alcohol on highway driving in the STISIM driving simulator. Hum Psychopharmacol. 2011 Aug;26(6):434-9. doi: 10.1002/hup.1226. Epub 2011 Aug 5.
Clinical trial NCT04261751: Moral Injury Symptom Scale/Moral Injury Outcome Scale
Official title: Validation of the Moral Injury Symptom Scale Clinician Version Short Form and Moral Injury Outcome Scale in Nurses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moral Injury
Anxiety
Depression
Burn-Out
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Licensed nurses at identified hospital within the state of Florida

Brief summary: The purpose of this research is to validate the moral injury symptom scale clinician version short form and the Moral Injury Outcome Scale in nurses. Participants will be recruited in accordance with AdventHealth Policy # 400.120: Selection and Enrollment of AdventHealth Employees, Physicians, and Volunteers for research Studies. Employee participants will be assured participation in this study will not affect performance evaluation or employment-related decisions by peers or supervisors. No employees will be recruited by a direct supervisor. Recruitment of potential employees as participants will occur without coercion by the Principal Investigator (PI), by bulletin board advertisements, or through a third party unassociated in a power/supervisory relationship with the employee (i.e., researchers from Center for Whole-Person Research).


Eligibility criteria: Inclusion Criteria:

1. Currently working as a registered nurse (Licensed Practical Nurse, Registered Nurse, Assistant Nurse Manager, Nurse Manager, Nurse Educator) at identified hospital within the state of Florida
2. Access to computer or mobile device to complete the survey
3. Ability to read and understand English

Exclusion Criteria:

1. Any employee at identified hospitals who is not a licensed nurse

Primary outcomes:
measure: Moral Injury
timeFrame: 1 Day
Secondary outcomes:
measure: Spiritual Wholeness
timeFrame: 1 Day
measure: Social involvement/Social Support
timeFrame: 1 Day
measure: Depression
timeFrame: 1 day
measure: Burnout
timeFrame: 1 Day
measure: Anxiety
timeFrame: 1 Day
measure: Spiritual Well Being
timeFrame: 1 Day
measure: Moral injury
timeFrame: 1 Day
measure: PTSD
timeFrame: 1 Day
measure: Post-traumatic growth
timeFrame: 1 Day
measure: Nurse Job Satisfaction
timeFrame: 1 Day
measure: Satisfaction with care/time demands
timeFrame: 1 Day
measure: Prevalence of aggression
timeFrame: 1 Day
measure: Discrimination
timeFrame: 1 Day
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth
name: Hong Tao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925351: Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases
Official title: The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Autoimmune Disease
Crohn Disease
Inflammatory Disorder
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Takayasu Arteritis
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot
Primary purpose: DIAGNOSTIC

Brief summary: This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.

Detailed description: PRIMARY OBJECTIVES:

I. Determine how fluorine F 18 clofarabine (18F-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases.

II. Determine whether 18F-clofarabine can be used to image patients with autoimmune and inflammatory diseases.

OUTLINE:

Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years or older.
* Diagnosed with an autoimmune and inflammatory disorder.

Exclusion Criteria

* Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge.
* Patients unable to undergo or comply with PET/CT scanning due to pre-existing medical conditions including claustrophobia.

Primary outcomes:
measure: Standardized Uptake Value
timeFrame: Baseline up to 240 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Martin Allen-Auerbach
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616577: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine
Official title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inguinal Herniorrhaphy
Orchiopexy
Keywords: Caudal Epidural Ropivacaine
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 26
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements.


Eligibility criteria: Inclusion Criteria:

* Age 2 years or younger.
* Weight 33 kg or less.
* Scheduled for elective inguinal herniorrhaphy or orchiopexy.
* American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria:

* Age over 2 years.
* Weight over 33 kg.
* Allergy to ropivacaine.
* Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)

Primary outcomes:
measure: Usage of Pain Medications
timeFrame: Over 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Charles Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: