louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01274078: Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Official title: Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factors Cardiovascular Disease
Inflammation
Exercise
Sedentary Life
Keywords: inflammation
lipids
CRP
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 32
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: About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being "couch potatoes". All participants are also randomized to also consume 150 g of blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a week during the 4 week period. The exercise period and the "couch" period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* significant disease and disabilities that hinder running

Primary outcomes:
measure: markers for cardiovascular disease
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
Study officials:
References:
Clinical trial NCT02735278: Are There Different Objective Fixation Disparity Values for Two Different Test Paradigms
Official title: Are There Different Objective Fixation Disparity Values for Two Different Test Paradigms: Similar to Reading Dot Presentation and Text Reading? - How This Phenomenon Can be Explained
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vision Disparity
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults without binocular problems

Brief summary: In optometry, binocular coordination is measured subjectively. The result is subjective fixation disparity. In research different experiments have proven, that subjective and objective fixation disparity are different. A binocular eyetracker has to be calibrated. There are two well known calibration methods: associated and dissociated calibration. Objective fixation disparity is measured in arcMin. Therefore, the precision of the eyetracker plays a crucial role. Now, the investigators try to compare dissociated calibration with polarized filters and associated calibration under different test paradigms.


Eligibility criteria: Inclusion Criteria:

* VA without glasses/contact lenses 0.63
* Accurate accommodation on 57cm

Exclusion Criteria:

* Tiredness at day of investigation
* Presbyopia
* Alcohol or drug abuse
* No eye related pathology
* No strabism
* No known epilepsy-attack in family

Primary outcomes:
measure: Fixation disparity in arcMin during a reading and reading related dot paradigm
timeFrame: Through study completion, up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06321978: Mepilex Border Flex Utilization Pilot Spain
Official title: Observational Study to Describe the Utilization of Foam Dressings in Routine Clinical Practice, for the Treatment of Patients With Chronic Wounds in Primary Healthcare Centers in Spain.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wound
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is addressed to adult patients with chronic wounds- wounds that have not reduced in size by more than 40% to 50% or healed within a month, and who are already being treated with a foam dressing. The patient must be deemed by HPC to be treated with Mepilex® Border Flex according to the indications of the dressing.

Brief summary: The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older.
* The patient has been deemed by the HCP to change dressing to Mepilex® Border Flex.
* Patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that Mepilex® Border Flex, according to its intended use at baseline visit for minimum 4 weeks.
* Patients with an expectation of wound follow-up of at least 4 weeks.
* Patients agree only to have the dressing changed by the HCP.
* Patients capable of signing the Informed Consent Form and answer the questions being asked.

Exclusion Criteria:

* Patients with any applicable contraindication or sensibilization to any of the dressing compounds
* Patients with pressure ulcers (PU) stage I, deep tissue injuries or terminal wounds (e.g., fungating wounds)
* Patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area.
* Hospice patients
* Patients participating in other studies interfering with this study.

Primary outcomes:
measure: Dressing use
timeFrame: 4 weeks
Secondary outcomes:
measure: Wound characteristics
timeFrame: 4 weeks
measure: Wound management
timeFrame: 4 weeks
measure: Technical Performance (HCP evaluation)
timeFrame: 4 weeks
measure: Patient Experience (PRO)
timeFrame: 4 weeks
measure: Costs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: CS Ciudad Expo - Mairena de Aljarafe
state: Andalusia
Study officials:
References:
Clinical trial NCT00092378: A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Bunionectomy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 251
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 purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

Detailed description: The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Eligibility criteria: Inclusion Criteria:

* Bunion removal

Exclusion Criteria:

* Any known allergies to the study design

Primary outcomes:
measure: Overall analgesic effect over 8 hours
Secondary outcomes:
measure: Time to onset of analgesic effect.
measure: The use of supplemental analgesia on Days 2-3.
measure: Peak analgesic effect on Day 1.
measure: Overall safety and tolerability.
measure: The analgesic effect on Days 2-3.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069.
Clinical trial NCT02308878: Mobile Health Cognitive Stimulation in Heroin Users
Official title: Executive Functioning in Heroin Users Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Keywords: Opioid Abuse Disorder
Cognitive Therapy
Executive Function
Mobile Health
Rehabilitation
Lead sponsor: Universidade Lusófona de Humanidades e Tecnologias
Sponsor class: OTHER
Collaborators: name: Universidade Lusófona de Humanidades e Tecnologias
name: Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
First posted: 2014-12-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.


Eligibility criteria: Inclusion Criteria:

* Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study.

Exclusion Criteria:

* Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.

Primary outcomes:
measure: Change in the results of Frontal Assessment Battery - FAB
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sintra
country: Portugal
facility: Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
state: Lisboa
Study officials:
References:
Clinical trial NCT01059578: First Study in Humans With GSK206136
Official title: A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK206136 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin-1 Receptor Occupancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder and Anxiety Disorders
Keywords: Nk1 Antagonist and SSRI
Safety
First Time in Humans
Healthy Subjects
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology


Eligibility criteria: Inclusion Criteria:

* Healthy males aged 18-45 years, limited to 25-40 years of age for PET section

Exclusion Criteria:

* The subject has a positive: drug/alcohol, Hepatitis, HIV screen..
* The subject has a history of psychiatric illness suicidal attempts or behaviour.
* Abuse of alcohol.
* Clinically significant laboratory, ECG abnormality;
* The subject has recently received an investigational.
* Use of prescription or non-prescription drugs,
* History or presence of allergy to the study drug or drugs of this class,
* Donation of more than 500 mL blood within the 90 days before dosing.
* An unwillingness of male subjects to comply with contraceptive requirements
* Average daily caffeine intake exceeding Protocol requirements.

Primary outcomes:
measure: Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2
timeFrame: 12 weeks
Secondary outcomes:
measure: Brain receptor occupancy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03738371: Formation of Health Professionals Through in Situ Simulation to Improve Performances During the Initial Step of Thrombectomy for Ischemic Strokes
Official title: Optimization of Performances During Thrombectomy Through In Situ Simulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Time
Benefit of in Situ Simulation for This Kind of Training
Installation of the Patient Until the Percutaneous
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: health professionals

Brief summary: The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.

The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).


Eligibility criteria: Inclusion Criteria:

* voluntary professionals

Primary outcomes:
measure: Performance of the team
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital neurologique, Centre Hospitalier Universitaire
Study officials:
affiliation: Hospices Civils de Lyon
name: Lionel BAPTESTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811571: A Study of the Effectiveness of an Early Intervention on Adolescent Hazardous Gaming
Official title: A Study of the Effectiveness of a Mobile-based Early Intervention on Adolescent Hazardous Gaming
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gaming Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators established a mobile-based early intervention on adolescent hazardous gaming and verified its effectiveness.

Detailed description: Hazardous gaming is the precursor of gaming disorder. Early intervention on hazardous gaming is an effective strategy to prevent gaming disorder. Currently, there are few evidence-based early interventions, particularly the technology-based approaches with the advantage of user-friendliness. This study developed a mobile-based early intervention program based on cognitive-behavioral therapy (CBT) for adolescent hazardous gaming. In order to verify the effectiveness of the intervention, adolescent participants were recruited and divided into two groups. The intervention group received the one-month intervention, while the control group did not. Both groups accepted the assessments at baseline and two months after the intervention. Comparative analysis was carried out between the two groups and two time points, primarily on the severity of gaming disorder, gaming hours, gaming frequency, anxiety, depression and self-esteem.

Eligibility criteria: Inclusion Criteria:

* (1) Clinical diagnosis of hazardous gaming defined in the ICD-11 (2) Fully comprehending the research's purpose and procedures and signing the informed consent

Exclusion Criteria:

* (1)Serious physical illness or intellectual disability (2) Clinical diagnosis of gaming disorder (3) Not completing all the interventions or assessments

Primary outcomes:
measure: the severity of gaming disorder
timeFrame: baseline, two months after intervention
Secondary outcomes:
measure: average daily gaming hours
timeFrame: baseline, two months after intervention
measure: frequency of gaming sessions
timeFrame: baseline, two months after intervention
measure: anxiety severity
timeFrame: baseline, two months after intervention
measure: depression severity
timeFrame: baseline, two months after intervention
measure: self-esteem
timeFrame: baseline, two months after intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Na Zhong, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06831578: Compare the Perioperative Analgesic Effect of Ultrasound Guided Thoracic Paravertebral Block and Ultrasound Guided Serratus Anterior Block in Patients Undergoing Thoracotomy
Official title: Analgesic Efficacy of Ultrasound-guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Plane Block in Patients Undergoing Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Thoracotomy
Thoracotomy Analgesia
Keywords: analgesia
thoracotomy
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consenting patients will be assigned randomly (1:1) into two groups. Both groups will receive general anesthesia and after induction an ultrasound guided serratu anterior plan block will be performed for one group and an ultrasound guided paravertebral plan block will be performed for the other. In both groups a loading dose of the local anesthetic (LA) solution( 20 ml of 0.25% bupivacaine ) will be injected before the surgical procedure
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.

Detailed description: randomized, comparative study General anesthesia will be conducted

Eligibility criteria: Inclusion Criteria:

* : Patients 20 to 60 years old
* ASA physical status of class II and III.

Exclusion Criteria:

Patients with severe respiratory disease

* preexisting neurologic deficit
* allergy to any of the study drug
* kypho-scoliosis
* presence of local infection
* on current chronic analgesic therapy, having history of opioid dependence'
* patient refusal
* inablity to communicate with the investigators
* who will require postoperative mechanical ventilation .

Primary outcomes:
measure: postoperative pain
timeFrame: postoperative up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shebeen elkom
country: Egypt
facility: Menoufia university hospital
state: Menoufia
city: Shebin elkom
country: Egypt
facility: Menoufia faculty of medicine hospital
Study officials:
References:
Clinical trial NCT03725371: Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
Official title: Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conduct Disorder
ADHD
Oppositional Defiant Disorder
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 133
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves children and adolescents diagnosed with disruptive behaviour disorder (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention deficit / hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive type or ADHD predominantly hyperactive-impulsive type).

Brief summary: This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about participants' level of aggression through the Reactive-Proactive Aggression Questionnaire (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their RPQ scores and clinical diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Subjects between ages 7 and 16 years
2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
3. Subjects with willingness to participate in a randomized, double-blind controlled trial
4. Subjects with complete written, informed parental consent and child assent
5. Subjects with IQ of 70 or more

Exclusion Criteria:

1. Subjects who have IQ in the below 70
2. Subjects who are younger than 7 years old or older than 16 years old
3. Those without written parental consent
4. Those with brain pathology such as serious head injury, epilepsy, etc.

Primary outcomes:
measure: Heart Rate
timeFrame: 7 minutes
measure: Skin Conductance Response
timeFrame: 4 minutes
measure: Skin Conductance Response
timeFrame: 4 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Daniel Fung
role: STUDY_DIRECTOR
References: