louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02277015: Intubation During Pediatric Resuscitation
Official title: Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Endotracheal Intubation
Pediatric Manikin
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Intubation Time
timeFrame: 1 month
Secondary outcomes:
measure: Successful intubation
timeFrame: 1 month
measure: POGO score
timeFrame: 1 month
measure: VAS score
timeFrame: 1 month
measure: Preferred ETI device
timeFrame: 1 month
measure: First Pass Attempt
timeFrame: 1 month
measure: Overall Success
timeFrame: intraoperative
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05594615: Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
Official title: A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
* A positive urine drug screen at Screening or Day -1
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
* History of regular alcohol consumption
* Participation in a clinical trial within 30 days prior to the first dose of study drug
* History of drug allergy to midazolam, caffeine, or rosuvastatin

Primary outcomes:
measure: Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
timeFrame: Up to 17 Days
measure: AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
timeFrame: Up to 17 Days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 22 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON, plc.
state: Utah
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02933515: Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke
Official title: Merging Yoga and Group OT (MY-OT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: yoga
occupational therapy
stroke
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2016-10-14
Enrollment: 14
Sex: ALL
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The long-term goal of this project is to advance best practices in occupational therapy (OT) to manage fall risk factors and reduce fall rates in older adults with stroke. To address this long-term goal, this team previously developed and pilot-tested a therapeutic yoga intervention to improve balance, balance self-efficacy, and fear of falling and a group OT intervention to improve the management of fall risk factors and fear of falling. The success of both prior studies supports Merging Yoga and group OT to improve balance, balance self-efficacy, and fall risk factor management. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

Detailed description: 8 week intervention of yoga plus occupational therapy. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

Eligibility criteria: Inclusion Criteria:

* stroke \>6 months prior
* 59 years or older
* prior fall or Fear of Falling (FoF)
* completed all stroke rehabilitation
* able to stand with or without an assistive device
* impaired balance with a score of \<46 on the Berg Balance Scale
* able to speak English
* score \>4 out of 6 on the short Mini Mental Status Exam (Callahan, Unverzagt et al., 2002)
* able and willing to attend twice weekly sessions for 8 weeks.

Exclusion Criteria:

* people with life expectancy \<9 months;
* inability to attend sessions due to unresolved transportation issues;
* inability or refusal to provide informed consent

Primary outcomes:
measure: Change in balance using Berg Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in balance confidence using Activities Balance Confidence Scale
timeFrame: 8 weeks
measure: Change in falls management behaviors using the Falls Management Behavior Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02148315: School Gardens and Physical Activity
Official title: School Gardens and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
children
school
garden
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 234
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether school gardens affect children's physical activity.

Detailed description: New York State schools were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline data collection.

Eligibility criteria: Inclusion Criteria:

* schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
* schools did not already have a school garden

Exclusion Criteria:

-

Primary outcomes:
measure: change in physical activity
timeFrame: change from baseline to follow-ups at 6, 12, 18 months
Secondary outcomes:
measure: change in time spent outdoors
timeFrame: baseline to follow-ups at 6, 12, 18 months
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Schools in New York State
state: New York
Study officials:
affiliation: Cornell University
name: Nancy M Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells NM, Myers BM, Henderson CR Jr. Study protocol: effects of school gardens on children's physical activity. Arch Public Health. 2014 Dec 8;72(1):43. doi: 10.1186/2049-3258-72-43. eCollection 2014.
citation: Wells NM, Myers BM, Henderson CR Jr. School gardens and physical activity: a randomized controlled trial of low-income elementary schools. Prev Med. 2014 Dec;69 Suppl 1:S27-33. doi: 10.1016/j.ypmed.2014.10.012. Epub 2014 Oct 16.
Clinical trial NCT02184715: Effects of Virtual Reality System in Children With Developmental Delays
Official title: The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Developmental Delays
Keywords: virtual reality system, children, developmental delay
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 157
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.

Detailed description: Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.

Eligibility criteria: Inclusion Criteria:

* confirmed to have developmental delays
* provided informed consent
* 2 to 12 years old

Exclusion Criteria:

* failed to provide informed consent

Primary outcomes:
measure: health of children (Pediatric Quality of Life Inventory)
timeFrame: changes from baseline at one and two months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh RL, Lee WC, Lin JH. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial. PLoS One. 2016 Mar 16;11(3):e0149714. doi: 10.1371/journal.pone.0149714. eCollection 2016.
Clinical trial NCT06317415: Intervention on Non-prescription Antibiotic Use Among the Public
Official title: Effect of Health Education on Non-prescription Antibiotic Use Among the Public: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Prescription Drug Misuse
Antibiotic Use
Keywords: Cluster randomized trial
Non-prescription
antibiotic
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Fuyong People's Hospital, Bao 'an District, Shenzhen City, Guangdong
First posted: 2024-03-19
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75 years old;
* Local residents (residing for more than 6 months) with no plans for employment, study, or relocation in the next six months;
* Having normal cognitive, comprehension, and independent communication abilities, and voluntarily participating in this study;
* Able to use WeChat independently or with guidance from family members.

Exclusion Criteria:

* Unable to comprehend the purpose of the survey, unwilling to cooperate, or lacking willingness to provide honest answers to questions;
* Illiterate, severely physically disabled, or lacking necessary comprehension abilities;
* Healthcare professionals, such as doctors, nurses, pharmacists, etc.;
* Individuals with autoimmune diseases or hereditary diseases affecting the use of common medications;

Primary outcomes:
measure: Rate of non-prescription antibiotic use among the public
timeFrame: within one month
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuyong People's Hospital
state: Guangdong
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiaoxv Yin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04484285: Home Operations Utilizing Stimulation
Official title: Home Operations Utilizing Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.

Detailed description: The vagal nerve is a major component of the autonomic nervous system and mediates the physiological responses of major organs during moments of stress and learning, including brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been indicated to improve stress response and to enhance neuroplasticity by directly impacting brain structures critical for cognition. Historically, VNS methods required neurosurgery and were reserved for medically intractable epilepsy or other severe conditions. Today, vagal nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will utilize a home-operated stimulator in healthy young adult and healthy older populations to provide a proof of concept of practical home-use stimulation.

Eligibility criteria: Inclusion Criteria:

* Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
* Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

Exclusion Criteria:

* Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
* Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.

Primary outcomes:
measure: System Usability Scale
timeFrame: Day 7 reported
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida McKnight Brain Institute
state: Florida
Study officials:
References:
Clinical trial NCT00857285: Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
Official title: A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Taiwan Ltd.
First posted: 2009-03-06
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.


Eligibility criteria: Inclusion Criteria:

* Diastolic BP 95 mm Hg - 114 mm Hg inclusive
* No participation in any clinical trial for the last 3 months

Exclusion Criteria:

* Secondary hypertension
* Malignant hypertension
* Severe arterial hypertension
* Significant cardiovascular disease
* History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
* Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems

Primary outcomes:
measure: Mean Change of Sitting dBP From Baseline to Week 12
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung City
country: Taiwan
facility: Chung Shun Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06301685: Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder
Official title: Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autistic Disorder
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Detailed description: Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as Autistic Disorder.
* Aged between 3 years old and 6 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria:

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions

Primary outcomes:
measure: Childhood Autism Rating Scale
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Children's Communication Checklist
timeFrame: day 1 and day 10
measure: Social Interaction Assessment Scale
timeFrame: day 1 and day 10
measure: Children's Depression Inventory
timeFrame: day 1 and day 10
measure: Childhood Anxiety Sensitivity Index
timeFrame: day 1 and day 10
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: