louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01373632: Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
Official title: Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: significant stenosis (>70% of lumen stenosis)
epicardial coronary arteries
clinical ischemic
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 570
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: Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* male or un-pregnant female
* stenosis \> 70% in one of major the epicardial coronary arteries
* no contra-indications of stent implantation
* singed the informed consent

Exclusion Criteria:

* acute myocardial infarction within one week
* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
* no history of stent implantation within last one-year
* received other brand coronary stent during index procedure
* with no achievement of informed consent

Primary outcomes:
measure: in-stent late lumen loss at 9 months' angiographic follow-up
timeFrame: 9 months
Secondary outcomes:
measure: target vessel failure
timeFrame: 2 years after index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
citation: Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.
citation: Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.
Clinical trial NCT06313632: Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy
Official title: A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pleural Disease
Postoperative Pain
Keywords: Thoracoscopy
Pleuroscopy
Regional Anesthesia
Erector Spinae Plane Block
Pain Control
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 33
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: PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.

Detailed description: This is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (ESP) block with Bupivacaine in reducing pain after medical thoracoscopy (MT). The study aims to compare the effectiveness of ESP block with monitored anesthesia care (MAC) vs MAC alone for patients undergoing MT. Patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.

Eligibility criteria: Inclusion criteria:

* Referral for medical thoracoscopy
* Age ≥ 18

Exclusion criteria:

* Inability to provide informed consent.
* Study subject has any disease or condition that interferes with safe completion of the study including:

  * Allergic reaction to Bupivacaine.
  * Need for pleurodesis.
  * Allergies to lidocaine or other local anesthetics.
  * Pregnancy.
  * Advanced liver disease where the clinician deems the procedure unsafe.

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 2 hours after the intervention
Secondary outcomes:
measure: Change in the Numerical Rating Scale
timeFrame: At 2 hours post-intervention and 24 hours post-intervention
measure: Type of Analgesic use
timeFrame: within the first 24 hours after the intervention
measure: Number of Analgesic use
timeFrame: within the first 24 hours after the intervention
measure: Dosage of Analgesic use
timeFrame: within the first 24 hours after the intervention
measure: Quality of Recovery-15 (QoR-15) Survey Score
timeFrame: within the first 24 hours after the intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West Hospital
state: New York
Study officials:
affiliation: Principal Investigator
name: Udit Chaddha, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06513832: Asthma Navigator Intervention to Improve Health Equity in Children
Official title: Asthma Navigator Intervention to Improve Health Equity in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma self-management
Asthma in Children
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Clinical & Translational Science Alliance (CTSA)
First posted: 2024-07-22
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:

* To identify the factors related to differential experiences of asthma self-management
* To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.

Detailed description: Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.

At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.

Eligibility criteria: Inclusion Criteria:

* Admitted to the PICU for asthma

Exclusion Criteria:

* Cystic fibrosis
* Immune deficiency
* Prematurity \<35 weeks
* Gestation and congenital airway deformities
* Non-English speaker

Primary outcomes:
measure: Future unscheduled healthcare utilization for asthma exacerbation
timeFrame: Baseline, end of study (average of 52 weeks)
Secondary outcomes:
Other outcomes:
measure: Hospitalization occurrence
timeFrame: Baseline, end of study (average of 52 weeks)
measure: Clinic follow-up
timeFrame: Baseline, end of study (average of 52 weeks)
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Anne Fitzpatrick, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810432: Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Official title: Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 40
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy participants as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
* Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

* Have known allergies to evacetrapib, related compounds or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
timeFrame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib
timeFrame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
timeFrame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03361332: The Sense of Agency
Official title: Behavioural and Neurofunctional Correlates of the Sense of Agency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Motor Activity
Motor Tic Disorders
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls and patients with Gilles de la Tourette Syndrome

Brief summary: The ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Despite a large number of behavioural studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the SoA and the distinction between causality and the SoA proper. Here, the investigators use an implicit measurement of the SoA and its modulations during fMRI: the intentional binding phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological correlates are modulated by the presence of a movement disorders, such as Gilles de la Tourette Syndrome.


Eligibility criteria: Inclusion Criteria:

* Age included between 18 and 65 years
* Right handed
* No contraindication to the fMRI exam

Exclusion Criteria:

* Contraindication to the fMRI exam

Primary outcomes:
measure: BOLD signal changes
timeFrame: April 2017 - October 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT04861532: Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
Official title: Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MRI Image Enhancement
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medic Vision Imaging Solutions
First posted: 2021-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Total number of subjects expected to participate in this study is up to 100. This study will be performed at multiple sites and data will be collected from different MRI scanners of variable field strength using several MRI protocols. To provide sufficient statistical power for the investigation of each subgroup, we need a large sample size.

Children, pregnant women and prisoners that are considered vulnerable population by federal regulation will not be included in this study. In addition, decisional incapacity subject will be excluded.

Brief summary: The purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Then post-processing will be applied on new protocols to enhance the image quality. Finally a comparison of image quality will be performed to compare the image quality of images obtained by conventional protocols with those obtained with the New Protocols.


Eligibility criteria: Inclusion Criteria:

* Volunteers for clinical MRI examination
* Patients undergoing clinical MRI examination
* Capable to provide an informed written consent form

Exclusion Criteria:

* Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).
* Age \<18 years old
* Pregnancy
* Claustrophobia

Primary outcomes:
measure: Image Signal to Noise Ratio (SNR)
timeFrame: Through study completion, an average of 2 months.
measure: Image Resolution
timeFrame: Through study completion, an average of 2 months.
measure: Artifacts
timeFrame: Through study completion, an average of 2 months.
measure: MRI contrast
timeFrame: Through study completion, an average of 2 months.
measure: Diagnostic quality
timeFrame: Through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe
state: Select One
Study officials:
affiliation: Medic Vision Imaging Solutions Ltd
name: Libi Mori
role: STUDY_DIRECTOR
affiliation: Hillel Yaffe Medical Center
name: Roni Shreter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04559932: Paediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-based Education Program for Community Health Care Providers
Official title: Paediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-based Education Program for Community Health Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of HomeCare RN Respiratory Education
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 44
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will evaluate a new course developed for nurses that provide care to children with breathing technology including breathing tubes and home breathing machines. The investigators plan to assess the nurses' knowledge and comfort of their ability to care for these medical technologies prior to the course as well as their ability to retain their knowledge 6 weeks and 6 months after course completion.

Detailed description: A structured program evaluation considering a hierarchy of outcomes is essential to determine whether the tracheostomy module is associated with improved knowledge and skills for CHPs (community health providers). This investigators proposed study is guided by the evaluation of knowledge acquisition and self-efficacy as a theoretical framework 24. CHPs' sense of self-efficacy or perceived capability in caring for this population is important to foster to potentially mitigate significant morbidity and mortality, while ultimately striving for safe, high-quality clinical care for these medically complex children.

Eligibility criteria: Inclusion Criteria:

* Course registrants for the competency-based tracheostomy education course from VHA Home Healthcare agency
* Consent to study participation
* English speaking

Exclusion Criteria:

• Previously attended the competency-based tracheostomy course at SickKids

Primary outcomes:
measure: The difference in the immediate knowledge retention scores of tracheostomy course participants versus controls at 6 week follow-up
timeFrame: 6 weeks
Secondary outcomes:
measure: The difference in the sustained knowledge retention scores of course participants versus controls at 6 month follow-up
timeFrame: 6 weeks and 6 months
measure: The difference in the self-efficacy scores of course participants versus controls at 6 weeks and 6 month follow-up
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Shi JY, Orkin J, Walsh CM, Chu S, Keilty K, McKay S, Mocanu C, Qazi A, Ambreen M, Amin R. Pediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-Based Education Program for Community Health Care Providers. Front Pediatr. 2022 May 31;10:885405. doi: 10.3389/fped.2022.885405. eCollection 2022.
Clinical trial NCT00817232: Effectiveness of Microcurrent for Treatment of Tennis Elbow
Official title: Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tennis Elbow
Keywords: tennis elbow
microcurrent
tissue healing
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 24
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: Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.

A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.


Eligibility criteria: Inclusion Criteria:

* symptoms of tennis elbow for at least 3 months
* clinical diagnosis of tennis elbow

Exclusion Criteria:

* significant symptom improvement in previous month
* receipt of any active treatment for the condition in the previous month
* currently under the care of another health professional for tennis elbow
* current cervical radiculopathy
* other pathology affecting distal upper limb

Primary outcomes:
measure: Tendon pathology as indicated by sonography
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Patient-Rated Global Change Score
timeFrame: 3 weeks, 6 weeks, 4 months
Secondary outcomes:
measure: Pain Free Grip Strength
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Patient-rated Tennis Elbow Questionnaire
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Patient-Specific Functional Scale
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Adverse events
timeFrame: 3 weeks, 6 weeks, 4 months
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: Hertfordshire
Study officials:
References: