louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03628989: Technology-Based Distractions During Minor Procedures
Official title: Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Procedural Anxiety
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 58
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.


Eligibility criteria: Inclusion Criteria:

* Age 17 and under
* Able to consent or have parental consent
* Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Non-English Speaking
* Patients who clinically unstable or requires urgent/emergent intervention
* (ASA) Physical status classification class 4 or higher
* Patient or parental preference for General Anesthesia

Primary outcomes:
measure: Measure anxiety score
timeFrame: Duration of procedure (usually no more than 2-4 hours)
Secondary outcomes:
measure: Parent and Child Satisfaction Questionnaire
timeFrame: Duration of procedure (usually no more than 2-4 hours)
measure: Virtual and Augmented Reality Feedback Survey
timeFrame: Duration of procedure (usually no more than 2-4 hours)
measure: Asses cumulative medication dosing and the duration of procedure
timeFrame: Duration of procedure (usually no more than 2-4 hours)
measure: Evaluation of Passive vs Active Interventions
timeFrame: Duration of procedure (usually no more than 2-4 hours)
Other outcomes:
measure: Fear assessment
timeFrame: Duration of procedure (usually no more than 2-4 hours)
measure: Pain Assessment
timeFrame: Duration of procedure (usually no more than 2-4 hours)
measure: Procedural Compliance
timeFrame: Duration of procedure (usually no more than 2-4 hours)
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Thomas J Caruso, MD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Samuel Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363189: Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
Official title: Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Reconstruction
Breast Cancer
Keywords: breast reconstruction
plastic surgery
microsurgery
free flap
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-05-05
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biological women undergoing breast reconstruction with a deep inferior epigastric artery perforator flap in Sahlgrenska university hospital.

Brief summary: Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Operated or will be operated with a DIEP flap in the department
* \>18 years of age

Exclusion Criteria:

* Inability to leave informed consent
* Inability to understand and speak Swedish (for the questionnaire)

Primary outcomes:
measure: Re-operations
timeFrame: 7 days
measure: Length of stay (LOS) in hospital
timeFrame: 7 days
Secondary outcomes:
measure: Patient reported satisfaction and quality of life
timeFrame: 12 months
measure: Surgical corrections
timeFrame: 5 years
measure: Costs
timeFrame: 5 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References:
Clinical trial NCT06332989: Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting
Official title: Comparison of Prehospital Stroke Screening Scales in the Ambulance Setting; a Multiregional, Multicenter Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Pre-hospital Triage
Stroke Treatment
Stroke Code
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Alrijne Ziekenhuis Leiderdorp
name: Groene Hart Ziekenhuis
name: Medical Center Haaglanden
name: HagaZiekenhuis
name: Reinier de Graaf Groep
name: Regionale Ambulance Voorziening Hollands Midden
First posted: 2024-03-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients for whom a stroke code was activated.

Brief summary: There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics

Detailed description: this is a multicenter multiregional cohort study including about 3000 stroke code patients. In all patients an application will be filled out before hospital arrival including items that enable us to reconstruct all previously published stroke scales.

Data from the application will be related to in hospital data of the same patient. In order to do this we will use a trusted third party for data coupling.

Eligibility criteria: Inclusion Criteria:

* patients for whom a stroke code is activated

Exclusion Criteria:

\< 18 years

Primary outcomes:
measure: final diagnosis
timeFrame: discharge or after 3 months
measure: treated with reperfusion therapy
timeFrame: first 24 hours after admission
measure: additional investigations
timeFrame: on admission
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University medical center
Study officials:
References:
Clinical trial NCT06426589: Exercise and Nutrition in the Mental Health of the Older Adult Population
Official title: Resistance Training and Mediterranean Diet in the Mental Health of the Older Adult Population: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life.

For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs.

The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system.

The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds


Eligibility criteria: Inclusion Criteria:

* Were 65 years or older were eligible for the study
* Had not been part of any resistance program in the last 12 months
* They could understand and follow the instructions, activities and protocols of the exercise program.

Exclusion Criteria:

* They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises.
* Had any vestibular disease or disorder
* Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics).

Primary outcomes:
measure: Adherence to the Mediterranean Diet
timeFrame: Up to twelve weeks
measure: Anxiety and depression
timeFrame: Up to twelve weeks
measure: Sleep quality
timeFrame: Up to twelve weeks
measure: Perceived stress
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Agustín Aibar Almazán
Study officials:
References:
Clinical trial NCT06791889: Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study
Official title: Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Bloodstream Infections
Critically Ill Intensive Care Unit Patients
Keywords: ddPCR
Sepsis
ICU
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU

Brief summary: The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.

Detailed description: This is a monocentric observational study. Patients admitted to the ICU with a first diagnosis of sepsis will be dynamically monitored for nucleic acid loads of pathogenic bacteria in the blood using ddPCR at different time points until the last blood sample is taken on day 28-30 or the patient is discharged from the ICU.

Eligibility criteria: Inclusion Criteria:

* Patients with first diagnosis of sepsis after ICU admission

Exclusion Criteria:

* Age under 18 years
* Do not meet Sepsis 3.0 diagnostic criteria
* Refusal to sign informed consent

Primary outcomes:
measure: Nucleic acid load of pathogenic bacteria at different time points
timeFrame: ''Nucleic acid load of pathogenic bacteria in the blood versus time'' could have a time frame of ''0, 2-3, 4-5, 6-7, 8-9, 10-12, 13-15, 20-22, 28-30 days post admission to the ICU with the first diagnosis of sepsis''.
Secondary outcomes:
measure: 28-day mortality
timeFrame: Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
References:
Clinical trial NCT06834789: A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)
Official title: A Phase 1 Study With AGN-151586 and OnabotulinumtoxinA in Subjects for Treatment of Glabellar Lines (GL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Glabellar Lines
Keywords: Glabellar Lines
AGN-151586
OnabotulinumtoxinA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 126
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 objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).


Eligibility criteria: Inclusion Criteria:

* Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
* Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.

Exclusion Criteria:

* Active infection or dermatological condition at the treatment injection sites.
* History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 10.4 months
measure: Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
timeFrame: Up to approximately 10.4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD /ID# 270771
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation /ID# 270827
state: California
city: Redondo Beach
country: United States
facility: Marcus Facial Plastic Surgery /ID# 270770
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 270831
state: Florida
city: Chestnut Hill
country: United States
facility: Skincare Physicians /ID# 271018
state: Massachusetts
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 270828
state: North Carolina
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research - Pflugerville /ID# 270834
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 270932
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337489: Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)
Official title: REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Keywords: coronavirus
remote monitoring
deterioration
escalation
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: CW+ Charity
First posted: 2020-04-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Returning traveller from a high-risk area into a London airport.
* Have mild symptoms indicative of Covid-19
* Unable to self-isolate

Brief summary: The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over.
* Able to provide written consent.

Exclusion Criteria:

* Any participants that withdraw their consent.
* A skin condition/reaction preventing wearing the wearable sensor.
* The presence of a permanent pacemaker or cardiac defibrillator.
* Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
* Inability to cooperate or communicate with the research team.

Primary outcomes:
measure: Deterioration Resulting in Healthcare Review
timeFrame: 1 year
Secondary outcomes:
measure: Hospitalisation
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Institute of Global Health Innovation
name: Ara Darzi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2). BMC Public Health. 2021 Apr 1;21(1):638. doi: 10.1186/s12889-021-10660-9.
citation: Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). Pilot Feasibility Stud. 2021 Mar 5;7(1):62. doi: 10.1186/s40814-021-00804-4.
Clinical trial NCT04268589: Virtual Reality Effect in Geriatric Individuals
Official title: Effect of Virtual Reality Application on Pain, Functional Independence and Depression in Geriatric Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Depression
Keywords: geriatric pain
geriatric depression
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine the effect of a virtual reality experience on pain, depression and functional adequacy in geriatric individuals living in a nursing home.

A virtual reality video with dance moves has been applied to the experimental group participants. Each video takes 3 minutes, and the elderly person has been put into practice at least 30 minutes after having breakfast in 3-minute periods and at least 30 minutes after dinner. In the morning and evening, 15 minutes, 2 times a day, a total of 9 days were applied for 3 weeks. The application lasted a total of 3 weeks. Scales were applied 1 week after the virtual reality application was completed and 1 month after the experimental group. The scales were filled in the control group at the same time.

Detailed description: It is recommended that the future studies be conducted with larger samples on pain, depression, life quality and functionality.

Eligibility criteria: Inclusion Criteria:

* Suffering from musculoskeletal pain in the last 3 years,
* Being energetic (Being independent in the daily life activities),
* Being able to stand up without help before 30 seconds and walk at least six meters without help,
* Individuals with blood sugar ranging between 90-200 mg/dl prior to the application,
* Individuals with blood pressure ranging between 130-70 mm/Hg prior to the application,
* Not having neurological and psychiatric diseases,
* No history of fall,
* Being literate,
* Not being visually-hearing impaired,
* Being able to communicate verbally.

Exclusion Criteria:

* Pependent patients
* Patients with psychiatric illness
* Patients with joint pain disease diagnosis

Primary outcomes:
measure: The visual analog scale (VAS)
timeFrame: nine days
measure: Geriatric Depression Scale
timeFrame: nine days
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Osmangazi University
Study officials:
affiliation: Kutahya University of Health Sciences
name: Gamze Unver
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk University
name: Halil Ibrahim Tuna
role: PRINCIPAL_INVESTIGATOR
affiliation: Osmangazi University
name: Guler Balci Alparslan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907189: Ambulation as a Factor on Oscillating Thermometry
Official title: Ambulation as a Factor on Oscillating Thermometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Neuropathy Peripheral
Lead sponsor: Podimetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study populations consists of patients at risk of diabetic foot ulcers and other inflammatory foot diseases with an existing prescription for monitoring with Podimetrics Remote Temperature Monitoring System.

Brief summary: This research study aims to better understand how the plantar temperature data collected by the Podimetrics RTM System corresponds to physical activity level in subjects.

Detailed description: Subjects with prescription for monitoring with Podimetrics RTM System will be assigned activity monitors to track physical activity. Data from the Podimetrics RTM System and the activity monitor will be assessed after one month of use to determine any correlation between the two data sets and adherence to the use of activity monitor.

Eligibility criteria: Inclusion Criteria: Study subjects must

* Be at least 18 years old
* Not be pregnant
* Provide informed consent
* Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System

Exclusion Criteria:

* Be younger than 18 years old
* Unable to understand English
* Unable to provide consent
* At the discretion of the investigator

Primary outcomes:
measure: Correlation of foot temperature data and daily activity in patients with emergent inflammation.
timeFrame: 1 month
Secondary outcomes:
measure: Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.
timeFrame: 1 month
Other outcomes:
measure: Usage rate for Podimetrics Mat
timeFrame: 1 month
measure: Usage rate for the activity monitor
timeFrame: 1 month
Locations:
city: Somerville
country: United States
facility: Podimetrics,Inc.
state: Massachusetts
Study officials:
affiliation: Podimetrics, Inc.
name: Brian Petersen, MS,MBA
role: PRINCIPAL_INVESTIGATOR
References: