louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01029197: Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse
Official title: Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Substance Abuse
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 45
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: Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and substance abuse among persons with serious mental illness (SMI) treated in a community setting.

Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center, served through the Orange Person Chatham (OPC) Area Program.

Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the CBT intervention plus treatment as usual; or, 2) treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* Currently receiving services at Freedom House
* Meet DSM-IV criteria for PTSD
* Meet criteria for Substance Use Disorder
* Able to understand and provide informed consent

Exclusion Criteria:

• Psychiatric hospitalization or suicide attempt in the past two months

Primary outcomes:
measure: Clinician Administered PTSD Scale
timeFrame: 3 months
Secondary outcomes:
measure: Addiction Severity Index
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Freedom House
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Karen J Cusack, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: William Blair, B.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05390697: Educational Videos to Address Vaccine Hesitancy in Childhood Immunization
Official title: Educational Videos to Address Vaccine Hesitancy in Childhood Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Refusal
Vaccine Hesitancy
Keywords: health education
health promotion
Indonesia
vaccination
vaccination hesitancy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vaccine hesitancy and the COVID-19 pandemic may threaten immunization coverage in children. This study aimed to evaluate the tailored educational videos to reduce vaccine hesitancy and analyze immunization completeness status. The investigators conducted an interventional quasi-experimental study in three subdistricts of North Jakarta, Indonesia. Participants were allocated into the intervention and control groups, and the Parent Attitudes about Childhood Vaccines (PACV) questionnaire was used to assess vaccine hesitancy status before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Parents with children aged 10-18 months
* Parents who had electronic devices that could play videos, such as smartphones or tablets
* Registered in the community health centers database.

Exclusion Criteria:

* Children had contraindicated for immunization
* Children were dropped out if they did not finish their studies.

Primary outcomes:
measure: The Parent Attitudes about Childhood Vaccines (PACV) Questionnaire
timeFrame: Five weeks after intervention
Secondary outcomes:
measure: Childhood routine immunization status
timeFrame: Five weeks after intervention
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Hartono Gunardi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398097: Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
Official title: Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Influenza
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.

Detailed description: During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.

Eligibility criteria: Inclusion Criteria:

* HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine

Exclusion Criteria:

* known allergy to egg
* presentation of any febrile illness ≥37.5°C on the day of vaccination
* any history of hypersensitivity reaction to previous influenza vaccination
* any other vaccinations within the past one month
* use of immunosuppressive agent
* recipient of blood product or immunoglobulins during the previous three months
* any other conditions that might interfere with the study results

Primary outcomes:
measure: The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
timeFrame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Secondary outcomes:
measure: Percentage of subjects with a post-vaccination titer ≥1:40
timeFrame: Outcome measure was assessed 4 weeks after vaccination
measure: GMT ratio of the post-vaccination titer to pre-vaccination titer
timeFrame: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
Other outcomes:
measure: Frequency and duration of local and systemic adverse events
timeFrame: Adverse events were recorded for 7 days.
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Hee Jin Cheong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seo YB, Lee J, Song JY, Choi HJ, Cheong HJ, Kim WJ. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother. 2016;12(2):478-84. doi: 10.1080/21645515.2015.1076599.
Clinical trial NCT01178697: Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)
Official title: Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Central Retinal Vein Occlusion
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ophthalmic Research Center
First posted: 2010-08-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute central retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.


Eligibility criteria: Inclusion Criteria:

* Recent onset (less than 3 months) central retinal vein occlusion

Exclusion Criteria:

* Any previous intervention

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: central macular thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Hossein medical center
Study officials:
References:
Clinical trial NCT04350697: Mini-invasive Approaches to Aortic Surgery
Official title: Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Surgical Injury
Surgical Procedure, Unspecified
Surgical Incision
Aortic Surgery
Keywords: miniinvasive surgery
aortic surgery
minithoracotomy
ministernotomy
outcomes
surgical complications
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Prof Sandro Gelsomino
name: Prof Edvin Prifti
name: Prof Guido Sani
name: Dr Aleksander Dokollari
First posted: 2020-04-17
Enrollment: 2425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for Aortic and/or Aortic Valve by miniinvasive approaches (ministernotomy or minithoracotomy)

Brief summary: There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.


Eligibility criteria: Inclusion Criteria:

- Indication for Aortic and/or Aortic Valve surgery

Exclusion Criteria:

- none

Primary outcomes:
measure: PO
timeFrame: 1 day after surgery
Secondary outcomes:
measure: EO
timeFrame: 1 month after surgery
measure: MO
timeFrame: 5 years after surgery
measure: LO
timeFrame: 10 years after surgery
measure: VLO
timeFrame: 20 years after surgery
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Massimo Bonacchi
Study officials:
References:
Clinical trial NCT02946983: Influence of Intragastric Fructose Infusion on Behavioural and Neural Responses to Negative Emotion Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will test whether a subliminal, intragastric dose of fructose is able to influence the emotional state at the behavioural and neural level, as has been previously shown for fatty acids. They will also examine the potential involvement of gut peptide release. Based on previous research using fatty acids, an attenuating effect of fructose compared to placebo on the induced negative emotional state is hypothesized at the self-report as well as the brain level.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (N=15)
* Male and female
* Age 18 - 60
* Body Mass Index (BMI) of 20 - 25 kg/m2
* Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

* Abdominal or thoracic surgery. Exception: appendectomy
* Gastrointestinal, endocrine or neurological diseases. Exception: IBS if the participant will be recruited in the patient group
* Cardiovascular, respiratory, renal or urinary diseases
* Hypertension
* Food or drug allergies
* Anemia
* Eating disorders
* Psychotic disorders
* Depressive disorders
* Emotional and/or restraint eating
* No medication on a regular basis, exception: oral contraception
* No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
* Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
* Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, ...
* Pregnant or breastfeeding women
* Claustrophobia

Primary outcomes:
measure: Functional brain images
timeFrame: From the start of the study until the endpoint of the study, with a total duration of 50 minutes
Secondary outcomes:
measure: Hunger scores
timeFrame: every 10 minutes since the scan starts until 40 minutes after the start of the scan
measure: Mood assessment via the Self Assessment Manikin questionnaire
timeFrame: every 10 minutes since the scan starts until 40 minutes after the start of the scan
measure: Gut hormone levels
timeFrame: every 10 minutes since the scan starts until 40 minutes after the start of the scan
Other outcomes:
Locations:
Study officials:
affiliation: University of Leuven
name: Jan Tack, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iven J, Biesiekierski JR, Zhao D, Tack J, Van Oudenhove L. Intragastric fructose administration interacts with emotional state in homeostatic and hedonic brain regions. Nutr Neurosci. 2022 Mar;25(3):581-592. doi: 10.1080/1028415X.2020.1781326. Epub 2020 Jun 19.
Clinical trial NCT04058483: Validating the New Remote Hypnotic Induction Profile (rHIP)
Official title: A Randomized Trial Validating the New Remote Hypnotic Induction Profile (rHIP) Against the Existing Hypnotic Induction Profile (HIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testing the Hypnotizability of Healthy Volunteers
Keywords: hypnosis
hypnotizability
validation
remote
Hypnotic Induction Profile
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to first undergo phone-administered testing vs. in-person testing.
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine if hypnotizability can be reliably tested over the phone, without having to see or touch a patient. The scores from a new test for hypnotizability by phone will be compared to the scores from a standard in-person test, to make sure the results are similar.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* Able to schedule a 15 minute in-person and phone appointment within a week of each other, during the study period.

Exclusion Criteria:

* Severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
* Has had prior hypnotizability testing using the HIP or enrolled in another hypnosis-related trial.
* hearing impairment that would preclude phone interviewing
* non-English speakers

Primary outcomes:
measure: Reliability of HIP and rHIP test scores
timeFrame: Through study completion, approximately 2 months.
Secondary outcomes:
measure: Hypnotizability and DES
timeFrame: Administered upon enrollment, prior to first hypnotizability test
measure: Hypnotizability and Tellegen
timeFrame: Administered upon enrollment, prior to first hypnotizability test
measure: Complications with phone-administered test
timeFrame: Through study completion, approximately 2 months.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University/Stanford Healthcare
state: California
Study officials:
References:
citation: Kittle J, Zhao E, Stimpson K, Weng Y, Spiegel D. Testing Hypnotizability by Phone: Development and Validation of the Remote Hypnotic Induction Profile (rHIP). Int J Clin Exp Hypn. 2021 Jan-Mar;69(1):94-111. doi: 10.1080/00207144.2021.1827937.
Clinical trial NCT02410083: Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent
Official title: Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ANEURYSM CORONARY ARTERY
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 448
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.


Eligibility criteria: Inclusion Criteria:

* Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
* Korean men and women between the age of 20 and 85
* Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.

Exclusion Criteria:

* Patients who were not treated with PCI or intended to treat with PCI but failed.
* Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
* Patients who had a history of alcohol abuse or intoxication.
* Patients who had hypersensitivity to clopidogrel or aspirin.
* Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) \> 3 times upper normal reference values.
* Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
* Patients who were pregnant, breastfeeding.
* Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
* Patients who medically, psychologically had investigational product administration's prohibition.
* Patients who were not participated in this clinical trial decided by other investigators.

Primary outcomes:
measure: % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
timeFrame: 8 weeks
Secondary outcomes:
measure: △ PRU = Post treatment PRU - Pre treatment PRU
timeFrame: 8 weeks
measure: △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122483: Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
Official title: Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic patients with a clinical suspicion of obstructive sleep apnea

Brief summary: This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Male
* 18-70 years old
* Presentation with symptoms suggestive of obstructive sleep apnea
* Diagnostic sleep study
* Blood draw

Exclusion Criteria:

* Prior (within past year) or current therapy for sleep apnea
* Use of opioid pain medication, steroids or allopurinol (within past 30 days)
* Use of chronic anti-inflammatory drugs (within past 7 days)
* Active cancer under current treatment or monitoring

Primary outcomes:
measure: Identification of OSA in high-risk individuals
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Sleep Center Orange County
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: SleepMed
state: South Carolina
Study officials:
affiliation: Beckman Coulter, Inc.
name: Paula C Southwick, PhD
role: STUDY_DIRECTOR
References:
citation: Fleming WE, Ferouz-Colborn A, Samoszuk MK, Azad A, Lu J, Riley JS, Cruz AB, Podolak S, Clark DJ, Bray KR, Southwick PC. Blood biomarkers of endocrine, immune, inflammatory, and metabolic systems in obstructive sleep apnea. Clin Biochem. 2016 Aug;49(12):854-61. doi: 10.1016/j.clinbiochem.2016.05.005. Epub 2016 May 13.
Clinical trial NCT00205283: Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Official title: Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agouron Pharmaceuticals
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.


Eligibility criteria: Inclusion Criteria:

* Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
* Patients willing to comply with the protocol
* Age greater than or equal to 18 years
* Virologically successful if already on an established regimen

Exclusion Criteria:

* Prior use of a protease inhibitor exclusive of nelfinavir
* Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
* Use of immunomodulators or vaccines for HIV disease
* Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
* Baseline ALT levels greater than five times the upper limit of normal

Primary outcomes:
measure: Virologic response
measure: Nelfinavir pharmacokinetics
Secondary outcomes:
measure: Impact of nelfinavir and M8 pharmacokinetics on virologic response
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Urban, MD
role: PRINCIPAL_INVESTIGATOR
References: