louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01157273: Evaluation of Physiological and Vocal Parameters in Volunteers of Both Genders Submitted to an Anxiogenic Task
Official title: Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Communication
Keywords: Behavior
Anxiety
Communication
Voice
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Associação Fundo de Incentivo a Psicofarmacologia
First posted: 2010-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty individuals participated in the study, being 18 (60.0%) female and 12 (40.0%) male. They were between 19 and 42 years old and their schooling ranged from fundamental school (primary and middle school) to post-graduation.

All the volunteers were in good health, had no history of psychiatric problems or alcohol and/or drug abuse, and did not report any vocal problems. Subjects excluded from the sample were chronic smokers; had paralysis or neurological diseases; had problems in the upper airways or allergic rhinitis at the moment of the experiment; used stimulant, psychotropic, anxiolytic, phytotherapic or antidepressant substances, and those who had ingested alcohol or coffee on the day of the experiment.

Brief summary: Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated Public Speaking (SPS) test, would change the responses of healthy individuals regarding physiological and vocal parameters. Method: The sample comprised 30 participants of both genders, 19-42 years old, with no history of psychiatric disorders. The score in the STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin conductance, temperature in the extremities, electromyogram of the frontal muscle and salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 45 years
* Volunteers with no psychiatric history and diagnosis of vocal problem
* Have a minimum of the average school

Exclusion Criteria:

* Chronic smokers
* Subjects with paralysis or neurological diseases
* Compromised upper airway at the time of the experiment
* User stimulants, psychotropic drugs, herbal medicines, tranquilizers, antidepressants
* Have drunk coffee or alcohol on the day of the experiment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: José Roberto Leite
Study officials:
affiliation: Universidade Federal da Paraíba
name: Anna Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00251173: Project Health Link: Connecting Patients With Services
Official title: Services Interventions for Injured ED Substance Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2005-11-09
Enrollment: 755
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary outcome variables for this trial include receiving an assessment and referral and treatment entry. Other outcomes include degree of treatment completion, substance-related measures, health service utilization, health status changes, and psychosocial factors.


Eligibility criteria: Inclusion Criteria:

* (1) adults age 19-60 presenting to the Hurley Medical Center ED within 24 hours of an injury; (2) ability to provide informed consent.

Additional inclusion criteria for intervention study: meets criteria for substance abuse or dependence for stimulants (cocaine powder, crack cocaine, methamphetamine, amphetamine), cannabis (marijuana, hashish), and or opioids (noninjected heroin, other opioids such as hydrocodone and oxycodone) in the previous year.

Exclusion Criteria:

* (1) adult patients who do not understand English; (2) prisoners; (3) adults classified by medical staff as "Level 1 trauma"; (4) adults deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence); (5) patients treated in the ED for suicide attempts and sexual assaults; (6) patients who have been in treatment for substance abuse in the past six months; (7) patients who are triaged to psychiatric emergency services; and (8) patients who report injecting heroin or other opiates in the past year.

Primary outcomes:
measure: receipt of assessment
timeFrame: 3 and 6 months post-baseline
measure: treatment entry
timeFrame: 3 and 6 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frederic C Blow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877031: Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion
Official title: Needle Guidance With Virtual Reality Augmented Ultrasound Versus Ultrasound Guidance Alone For Central Line Insertion: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line Complication
Keywords: central line
ultrasound guided central line insertion
virtual reality
augmented reality
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2013-06-13
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.

Detailed description: The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.

The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Require a central line inserted in the left jugular vein
* Undergoing surgery

Exclusion Criteria:

* Contraindication to left jugular vein insertion (absent vein, infection at site)
* Permanent or temporary pacemaker
* Emergency surgery

Primary outcomes:
measure: Time taken to insert needle
timeFrame: within 15 minutes
Secondary outcomes:
measure: Attempts
timeFrame: 15 minutes
measure: Carotid Puncture
timeFrame: within 24 hours
measure: Pneumothorax
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Daniel Bainbridge, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694031: Survival Study in Patients Undergoing On-line Hemodiafiltration
Official title: A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Keywords: Mortality
Convective therapies
On-line Hemodiafiltration
Dialysis Adequacy
Age 18 or older
Undergoing hemodialysis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Societat Catalana de Nefrologia
First posted: 2008-06-10
Enrollment: 906
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: Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Currently undergoing hemodialysis
* Clinical stability
* Stable vascular access

Exclusion Criteria:

* Chronic inflammatory diseases
* Liver cirrhosis
* Malignancies
* Chronic immunosuppressant or antiinflammatory use
* Dialysis through temporary catheter or single puncture

Primary outcomes:
measure: Survival
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: CSU Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
citation: Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. doi: 10.5301/jn.2010.386.
citation: Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.
Clinical trial NCT01509131: Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
Official title: Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Promefarm S.r.l.
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.


Eligibility criteria: Inclusion Criteria:

* Out-patients undergoing a complete colonoscopy
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Hypersensitivity to any of the ingredients
* History of anaphylaxis to drugs or allergic reactions in general
* Known or suspected gastrointestinal obstruction or perforation
* Toxic megacolon; major colonic resection
* Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
* Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
* Unwillingness to co-operate and to comply with the requirements of the trial

Primary outcomes:
measure: Evaluation of the quality of bowel preparation by BBPS
timeFrame: 20 minutes
Secondary outcomes:
measure: Difference in mucosal visibility between the two groups
timeFrame: 20 minutes
measure: Number of patients with adverse events
timeFrame: 24 hours
measure: Difference in tolerability between the two groups
timeFrame: 24 hours
measure: Difference in patients acceptability between the two groups
timeFrame: 24 hours
measure: Difference in patients compliance between the two groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Rozzano
country: Italy
facility: IRCCS Humanitas
state: Milano
city: Brescia
country: Italy
facility: Spedali Civili
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Roma
country: Italy
facility: Nuovo Regina Margherita
Study officials:
affiliation: IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spedali Civili di Brescia, Brescia - Italy
name: Renzo Cestari, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nuovo Regina Margherita, Roma - Italy
name: Cesare Hassan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy
name: Angelo Andriulli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Careggi, Firenze - Italy
name: Vito Annese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04010331: Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Official title: A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Keywords: Nokyong
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the efficacy and Safety of Nokyong Mixture Extract(CME-PI) on Promotion of Immunity

Detailed description: This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Nokyong Mixture Extract(CME-PI) group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.

Eligibility criteria: Inclusion Criteria:

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before the screening
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Primary outcomes:
measure: Changes of Natural Killer cell activity
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of Cytokines
timeFrame: 8 weeks
measure: Changes of Upper respiratory infection questionnaire score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT04180631: Quantitative US for Hepatic Steatosis
Official title: Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Steatosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medison
First posted: 2019-11-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.


Eligibility criteria: Inclusion Criteria:

* patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
* Signed informed consent

Exclusion Criteria:

* chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
* chronic alcoholics
* serum alanine transaminase (ALT)\>5 times the upper limit of normal within 3 months
* previous liver surgery
* acute hepatitis or bile duct obstruction

Primary outcomes:
measure: Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
timeFrame: 3 months
Secondary outcomes:
measure: Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
timeFrame: 3 months
measure: Correlation between S-shearwave elastography and MR elastography
timeFrame: 3 months
measure: Intra-observer agreement of quantitative ultrasound imaging parameter
timeFrame: same 1 day
measure: Development and validation of deep learning model for prediction of hepatic steatosis
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeon Min Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT05851131: Surveying Knowledge, Attitudes, and Practices of Primary Care Physicians in Turkey Regarding Osteoporosis Management.
Official title: Surveying Knowledge, Attitudes, and Practices of Primary Care Physicians in Turkey Regarding Osteoporosis Management.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family physician assistants, family physician specialists and general practitioners working in Turkey.

Brief summary: This study aims to assess the knowledge of primary care physicians on the diagnosis and treatment of osteoporosis.

Detailed description: Multiple choice questions will be used to assess information related to the diagnosis and treatment of osteoporosis, including knowledge of various medications, their mechanisms of action and side effects, and recommended dosage of vitamin D supplementation. The participating physicians will also be asked about their sources of knowledge acquisition and how they keep updated on this topic, as well as their self-evaluation of knowledge. Furthermore, background information will be collected, including professional and demographic characteristics. A questionnaire previously used in other studies will be adapted for the study based on the 'Updated approach for the management of osteoporosis in Turkey: a consensus report'.

Eligibility criteria: Inclusion Criteria:

* Giving consent.
* Working as a family physician assistant, family physician specialist or general practitioner in Turkey.

Exclusion Criteria:

* Not giving consent.
* Having any physical or mental illness that may prevent reading, understanding and filling out the form.

Primary outcomes:
measure: Knowledge levels, attitudes and practices of primary care physicians in Turkey
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: