louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03220412: Viewing Movie Violence & Interest in Guns
Official title: Exposure to Gun Violence in Movies Increases Interest in Real Guns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychology, Social
Adolescent Behavior
Keywords: adolescent
gun
violence
media
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 104
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to watch a movie containing guns, or a movie not containing guns.
Primary purpose: OTHER

Brief summary: More American children die by accidental gun use than children in other developed countries. One factor that can influence children's interest in guns is exposure to media containing guns. The objective of this study is to test whether children who see a movie containing guns will handle a real gun longer and will pull the trigger more times than children who see the same movie without guns.

Detailed description: A recent analysis of top selling films found that the depiction of guns in violent scenes in PG-13 films that target youth has increased from the level of G and PG files in 1985 when the rating was introduced, to the level of R films by 2005, to exceed the level of R films since 2012. By definition, a PG-13 movie is supposed to have less violence than an R-rated movie. The Motion Picture Association of America says on its website that the violence in a PG-13 movie "does not reach the restricted R category." Our study shows that it does. By including guns in violent scenes, film producers may be inadvertently increasing aggression in youth via a weapons effect. This experiment directly tests this hypothesis.

Eligibility criteria: Inclusion Criteria:

Age 8-12yrs, had not participated in study prior, was able to schedule participation with a known peer (8-12yo).

Exclusion Criteria:

Younger than 8yo, older than 12yo, had participated in study prior, could not schedule participation with a known peer (8-12yo)

Primary outcomes:
measure: Trigger Pulls
timeFrame: 20 minutes after intervention
measure: Seconds Holding Gun
timeFrame: 20 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Ohio State Universit
name: Brad J Bushman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dillon KP, Bushman BJ. Effects of Exposure to Gun Violence in Movies on Children's Interest in Real Guns. JAMA Pediatr. 2017 Nov 1;171(11):1057-1062. doi: 10.1001/jamapediatrics.2017.2229.
Clinical trial NCT05875012: Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia
Official title: Effect of Action Observation Physical Training on Quality of Upper Limb and Functional Independence in Children With Hemiplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: HCP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 30 children with a diagnosis of hemiplegic cerebral palsy

Detailed description: children aged 6-9 years were randomized into 2 groups, control group and study group

Eligibility criteria: Inclusion Criteria:

* manual ability classification system level II or III, Modified ashwarth scale 1+ or 2

Exclusion Criteria:

* visual or auditory problems ,fixed deformities

Primary outcomes:
measure: Quality of Upper Extremity skills test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
state: DOkki
Study officials:
References:
Clinical trial NCT01148212: Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)
Official title: Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Best Comfort and Lowest Skin Irritation
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: 15 healthy volunteers

Brief summary: Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes) in four different protocols:

saline-soaked sponges electrode with electrode gel tap-water-soaked sponges tap-water-soaked-sponges + sham stimulation

Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity


Eligibility criteria: Inclusion Criteria:

* no neurological or psychiatric illness
* written informed consent

Exclusion Criteria:

* dermatologic diseases
* medication with corticoids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilian-University, Dept. of Psychiatry
Study officials:
affiliation: Ludwig-Maximilian-University
name: Ulrich Palm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilian-University
name: Frank Padberg, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00715312: Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study
Official title: Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Inflammation
LDL
Oleic acid
Palmitic acid
trans fatty acid
C-reactive protein
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
First posted: 2008-07-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Rationale: The effect of positional distribution of dietary fatty acids on markers of inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid that are associated with reduced risk of cardiovascular disease is not widely studied.

Hypothesis: There would be difference detected in the concentrations of markers of inflammation and blood lipid metabolites in human volunteers fed controlled diets.

Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean oil in random order until all three diets has consumed by each person.

Main study parameters: LDL-cholesterol


Eligibility criteria: Inclusion Criteria:

* Healthy and free from any disease and absence of family history for arteriosclerosis or hypertension
* Not on any medication or supplements or weight loss program
* Non smokers and alcoholics

Exclusion Criteria:

* Having some health-related problems e.g fever, flu, allergy, chronic diseases
* On some treatment or medication
* Smokers and alcoholics

Primary outcomes:
measure: LDL-cholesterol
timeFrame: 5 weeks
Secondary outcomes:
measure: C-reactive protein
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysia Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Teng Kim Tiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03055312: Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer
Official title: A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metastatic Triple Negative Breast Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast

Detailed description: This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).

Eligibility criteria: Inclusion Criteria:

* Age: 18-70 years old, female
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
* For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
* Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
* After Recurrence has not received cancer treatment
* Life expectancy of at least 6 months
* Signed and dated an informed consent form

Exclusion Criteria:

* ECOG score ≧2
* Only brain metastasis or meningeal metastasis
* Receiving other anti-tumor treatment
* Heart,lung,liver,kidney,bone marrow,and other functions badness

Primary outcomes:
measure: Clinical benefit rate for 16 weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: progression-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-Yu Yuan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01091012: Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
Official title: Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Hypertension
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.


Eligibility criteria: Inclusion Criteria:

* Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure\> 50 mmHg,
* normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.

Exclusion Criteria:

* Patients with other cardiac and noncardiac diseases will be excluded.

Primary outcomes:
measure: Effectiveness
timeFrame: one day per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall Hebron Hospital
Study officials:
affiliation: Vall Hebron Hospital
name: Enric Domingo, Promotor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00699712: Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
Official title: Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Decompensated Heart Failure
Keywords: ADHF
AHF
HF
Lead sponsor: Nile Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Momentum Research, Inc.
First posted: 2008-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure


Eligibility criteria: Key Inclusion Criteria:

* Hospitalization for AHF
* In need of hemodynamic monitoring

Key Exclusion Criteria:

* Administration of intravenous radiographic contrast agent within 7 days prior to screening or planned IV contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
* Current or planned treatment with any IV therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
* Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
* Significant pulmonary disease
* Known valvular heart disease
* Any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
* Major surgery within 30 days of screening
* Other major disability or disease with expected survival less than 6 months.
* Major neurologic event, including cerebrovascular events, in the 60 days prior to screening
* Clinical diagnosis of acute coronary syndrome within 45 days of screening
* Troponin T ≥ 3 times the upper limit of normal at screening
* Significant arrhythmias
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
* Liver function abnormality
* Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening

Primary outcomes:
measure: Changes in cardiac output and wedge pressure
timeFrame: 8 hours
Secondary outcomes:
measure: Changes in additional hemodynamic measures
timeFrame: 8 hours
measure: Diuresis and natriuresis during and after administration of study drug
timeFrame: 36 hour
measure: Safety of CD-NP
timeFrame: 30 Days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences
state: Russia
Study officials:
affiliation: Nile Therapeutics Inc.
name: Hsiao Lieu, MD
role: STUDY_DIRECTOR
affiliation: Momentum Research, Inc.
name: Gad Cotter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01306812: Survey of Adolescent Living in Vestmanland
Official title: Risk Factors for Alcohol Abuse and Deviant Behaviour - Biochemical and Molecular Studies in Adolescents From Swedish County
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Abuse
Criminalism
Depression
Keywords: Adolescent
Alcohol
Criminology
Genes
Environment
Mono amine Oxidase
Serotonin
Social Support
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2011-03-02
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 16 and 19-year-olds school students in county of Vestmanland.

Brief summary: The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and psychosocial risk in relation to depressive symptoms among adolescents The interaction of MAO-A genotype and psychosocial risk, in relation to female adolescent criminality


Eligibility criteria: Inclusion Criteria:

All students present in school class during survey

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vasteras
country: Sweden
facility: Central Hospital
Study officials:
References:
Clinical trial NCT05810012: Comparison of Analgesic Efficacy of PENB Block with FICB in Post Operative Hip Fracture Patients
Official title: Comparison of Analgesic Efficacy of Ultrasound Guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block in Patients of Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-operative Pain Management
Hip Fracture Surgery
Lead sponsor: Pain Medicine Department
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 30
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 was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Patients in Group P were given pericapsular nerve group (PENG) block while those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as a secondary outcome.


Eligibility criteria: Inclusion Criteria:

* surgical correction of fracture neck of femur under spinal anaesthesia

Exclusion Criteria:

* allergy to local anaesthetics
* bleeding disorders
* morbid obesity with BMI more than 35
* patients of chronic pain
* drug addiction
* psychiatric issues

Primary outcomes:
measure: Pain score using Numeric Rating scale
timeFrame: 24 hours
Secondary outcomes:
measure: Total Tramadol consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pain Medicine Department
Study officials:
affiliation: Pain Medicine Department
name: Moazzam Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02631512: Evaluation of Woulgan in Diabetic Foot Ulcer
Official title: Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot Ulcers
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2015-12-16
Enrollment: 62
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 aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.


Eligibility criteria: Inclusion Criteria:

* Type I or II diabetes mellitus.
* Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
* Ankle-brachial pressure index above 0.7.

Exclusion Criteria:

* Ulcers due to non-diabetic etiology.
* Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status.
* Ulcers older than 1 year.
* Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.

Primary outcomes:
measure: Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.
timeFrame: Until 8 weeks from start of treatment
Secondary outcomes:
measure: Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events
timeFrame: Until 8 weeks from start of treatment
measure: Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS).
timeFrame: Until 8 weeks from start of treatment
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skaane University Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Skane University Hospital
name: Magnus Londahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224912: Internet Delivered Self-Help CBT for Insomnia
Official title: Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Insomnia
Intervention
Self-help
Internet
Lead sponsor: Utrecht University
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility criteria: Inclusion Criteria:

* Insomnia
* Access to the internet

Exclusion Criteria:

* Alcohol or substance abuse
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder

Primary outcomes:
measure: Sleep diary
timeFrame: baseline
measure: Sleep diary
timeFrame: 4-week follow-up
measure: Sleep diary
timeFrame: 18-week follow-up
measure: Sleep diary
timeFrame: 48-week follow-up
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 4-week follow-up
measure: Anxiety
timeFrame: 18-week follow-up
measure: Anxiety
timeFrame: 48-week follow-up
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: 4 week follow-up
measure: Depression
timeFrame: 18-week follow-up
measure: Depression
timeFrame: 48-week follow-up
measure: Sleep medication
timeFrame: Baseline
measure: Sleep medication
timeFrame: 4-week follow-up
measure: Sleep medication
timeFrame: 18-week follow-up
measure: Sleep medication
timeFrame: 48-week follow-up
measure: Insomnia Severity
timeFrame: Baseline
measure: Insomnia severity
timeFrame: four-week follow-up
measure: Insomnia severity
timeFrame: 18-week follow-up
measure: Insomnia severity
timeFrame: 48-week follow-up
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
affiliation: Utrecht University
name: Jaap Lancee, MSc
role: PRINCIPAL_INVESTIGATOR
References: