louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06857266: Remote Video-Delivered Suturing Education with Smartphones
Official title: Remote Video-Delivered Suturing Education with Smartphones: a Non-Inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Skill Training
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated to see if the students receiving video-delivered feedback improved just as much as students receiving in-person feedback.

Detailed description: Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated by blinded assessors to determine improvement using the University of Bergen suturing skills assessment tool (UBAT) and Objective Structured Assessment of Technical Skills (OSATS). Study arms were compared to the control arm in a non-inferiority analysis. Participants and feedback providers completed questionnaires regarding feasibility and utility of their feedback modality.

Eligibility criteria: Inclusion Criteria:

* First and second year students at McMaster University's Degroote School of Medicine

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in University of Bergen suturing skills Assessment Tool score
timeFrame: At 48 hours after feedback given to student
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT00268866: Danish Quality Assurance Project on Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Outpatient Lung Clinics
Official title: Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 1820
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics

Detailed description: Study Hypothesis:

Comparison(s):

none

Eligibility criteria: Inclusion Criteria:

* Outpatient with the diagnosis or referral diagnosis of COPD.
* COPD must be the primary reason for this outpatient contact (for both new patients and controls).

Exclusion Criteria:

* Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy).
* Asthma without the presence of COPD

Primary outcomes:
measure: To optimise the diagnosis and treatment of COPD via a quality assurance project
measure: Increase the knowledge and use of diagnostic tools and treatment options
measure: Increase focus on COPD comorbidity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: B.I. Denmark A/S
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT01680666: A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population
Official title: A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Need for Central Venous Access
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.


Eligibility criteria: Inclusion Criteria:

* All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia

Exclusion Criteria:

* Preoperative proof of non-patency of central veins
* coagulopathy
* access site surgeon

Primary outcomes:
measure: Success of Central Venous Cannulation at First Attempt
timeFrame: Up to 410 seconds
Secondary outcomes:
measure: Success of Central Venous Cannulation Within First Three Attempts
timeFrame: Up to 410 seconds
measure: Patients With Arterial Punctures
timeFrame: Up to 410 seconds
measure: Patients With Complications
timeFrame: Up to 410 seconds
measure: Time to Successful Cannulation
timeFrame: Up to 410 seconds
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
citation: Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.
Clinical trial NCT05490966: Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
Official title: Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tightness
Keywords: multifidus
erector spinae
muscle stiffness
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.

Detailed description: Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave elastography.

Eligibility criteria: Inclusion Criteria:

* Physically active at least 3 hours a week

Exclusion Criteria:

* Low back pain in the past 6 months
* History of chronic low back pain
* History of spinal or pelvic operation
* Hypermobility, more than 4 points on Beighton scale
* Cardiovascular or systemic diseases
* Pregnancy

Primary outcomes:
measure: Change of trunk extensors muscle stiffness
timeFrame: 1 hour
Secondary outcomes:
measure: Change of muscle electromyography mean amplitude
timeFrame: 1 hour
Other outcomes:
measure: Change in lumbar range of motion
timeFrame: 1 hour
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Matej Voglar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520466: Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease
Official title: Effect of Cocoa Flavanol-containing Drink on Coronary Vascular Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Coronary Heart Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)


Eligibility criteria: Inclusion Criteria:

Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention

* Age 20 - 80
* Written obtained informed consent

Exclusion Criteria:

* Acute ST-elevation myocardial infarction
* Acute non-ST-elevation myocardial infarction (enzyme positive)
* Ventricular tachy-arrythmias or AV-Block \>I°
* Renal insufficiency (GFR MDRD \< 30ml/min) or liver disease (ALT or AST \>150 IU)
* Pregnancy
* Known allergy to compounds of cocoa product
* Known allergy to contrast media
* Known allergy to nuts
* Intolerance to coffein and theobromin
* Acute infectious disease
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
* Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts
* No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)
* Extreme eating habits (as assessed by a questionnaire)
* Alcohol or drug abuse
* Lactose intolerance

Primary outcomes:
measure: coronary endothelial function as assessed as response to cold pressor test
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Cardiovascular Center Cardiology Univeristy Hospital of Zurich
city: Zurich
country: Switzerland
facility: Universisty Hospital of Zurich, Cardiovascular Center Cardiology
Study officials:
affiliation: University Hospital Zurich, Cardiovascular Center Cardiology
name: Thomas F Lüscher, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076866: Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism
Official title: Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Disease
Rheumatoid Arthritis
Spondyloarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with a inflammatory disease (rheumatoid arthritis and spondyloarthritis) follow-up in the rheumatologic department

Brief summary: It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

Detailed description: All subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (VS, CRP, ACPA, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), BMO Measure

Eligibility criteria: Inclusion Criteria:

* More than 18 years
* Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria

Exclusion Criteria:

* Patient under guardianship

Primary outcomes:
measure: therapeutic maintenance at 20 years of follow-up
timeFrame: 20 years
Secondary outcomes:
measure: evolution of lipidics parameters at 20 years of follow-up
timeFrame: 20 years
Other outcomes:
measure: evolution of BMD at 20 years of follow-up
timeFrame: 20 years
Locations:
city: Nice
country: France
facility: rheumatology department CHU nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: christian roux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044666: Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Official title: Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Keywords: Critical Limb Ischemia
Amputation
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)


Eligibility criteria: Inclusion Criteria:

* Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB
* Patient is unable to be treated by endovascular or surgical means

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has had a previous surgery within 30 days of the study procedure
* Patient has a planned surgical or interventional procedure within 30 days after the study procedure
* Patient has a life expectancy of less than 1 year
* Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.
* Additional restrictions as specified in the protocol

Primary outcomes:
measure: Frequency and types of adverse events
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Kong Teng Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02863666: Verification of Prediction Algorithm
Official title: Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shortness of Breath Episode
Tachycardia
Bradycardia
Difficulty Breathing
Keywords: Cariopulmonary, cardiac arrest
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 673
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: Subjects presenting to the emergency department with cardiopulmonary related complaints

Brief summary: Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

Detailed description: A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician.

Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.

Eligibility criteria: Inclusion Criteria:

18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system.

Exclusion Criteria:

Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State

Primary outcomes:
measure: Number of Subjects With a Cardiopulmonary Event
timeFrame: Within 72 hours of presentation to ED
Secondary outcomes:
measure: Cumulative Number of Cardiopulmonary Events in a Single Subject
timeFrame: Within 72 hours of presentation to ED
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Kurz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296966: A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
Official title: A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 40
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 purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age of either gender and any race.
* Provide written informed consent and sign the HIPAA form.
* Be willing and able to follow all instructions and attend all study visits.

Exclusion Criteria:

* Use of any of the disallowed medications during the washout and study period.

Primary outcomes:
measure: Schirmer's Tear Test
timeFrame: Measured over a 4-week treatment period
Secondary outcomes:
measure: Ocular Staining
timeFrame: Measured over a 4-week treatment period
measure: Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)
timeFrame: Measured over a 4-week treatment period
Other outcomes:
Locations:
city: Andover
country: United States
facility: Vanda Investigational Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT05383066: Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
Official title: Follow-up Registration Management of Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 490
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: This project is a non-interventional, prospective, multicenter, case follow-up registration management, aiming to observe and explore the impact of real-world anti-angiogenesis targeted therapy on the survival prognosis of patients with advanced liver cancer, and summarize the treatment experience of a wide range of people. Therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis targeted therapy in patients with advanced liver cancer.

Brief summary: To observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people.

Detailed description: This project is a non-interventional, prospective, multicenter, case follow-up registry management, aiming to observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people. Therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis combined with PD-1/PD-L1 therapy in patients with advanced liver cancer. 490 patients are planned for follow-up, and enrollment is expected for this program to last for 2 years, starting in December 2021 and ending with the last patient enrollment in December 2023. The treatment period was 24 months, and the patient follow-up was 24 months after the last patient was enrolled.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients;
3. doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy;
4. patients voluntarily join the program and sign informed consent.

Exclusion criteria:

The above selection criteria are not met

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 3-4 weeks
measure: Objective Response Rate
timeFrame: 3-4 weeks
measure: disease control rate
timeFrame: 3-4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03750266: 3D Animation and Models to Aid Management of Fetal CDH
Official title: The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 30
Sex: FEMALE
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: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study

Brief summary: We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.


Eligibility criteria: Inclusion Criteria:

* Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.
* Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI.
* Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study.

Exclusion Criteria:

* Not able to give informed consent due to any reason including poor understanding of English
* Under 18 years of age.
* Unable to complete the fetal MRI process due to either metal implants or claustrophobia.

Primary outcomes:
measure: Patient demographics
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Jessop Wing Hospital
state: South Yorkshire
Study officials:
References: