louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03826667: PMCF Study on PEEK Suture Anchors for Shoulder Indications
Official title: Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue to Bone Fixation
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received PEEK Suture Anchors implanted in the shoulder

Brief summary: Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have undergone shoulder joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria:

1. Subjects who are \< 12 months post-operative.
2. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.

Primary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention
timeFrame: 12 months
measure: Visual Analog Scale (VAS) - Pain
timeFrame: 6 and 12 months
measure: Count of Participants With Range of Motion (ROM) Full Functional Arc
timeFrame: 6 and 12 months
measure: Range of Motion (ROM)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: OrthoArizona
state: Arizona
city: Denver
country: United States
facility: University of Colorado- Denver
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital/Orthopedic Institute
state: Florida
city: Lawrenceville
country: United States
facility: OrthoAtlanta
state: Georgia
city: Oklahoma City
country: United States
facility: Community Hospital
state: Oklahoma
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Baytown
country: United States
facility: Houston Methodist at Baytown
state: Texas
city: Houston
country: United States
facility: Texas Orthopedic Hospital - Houston
state: Texas
city: New Berlin
country: United States
facility: Aspen Orthopedics at New Berlin
state: Wisconsin
city: West Allis
country: United States
facility: Aspen Orthopedics at West Allis
state: Wisconsin
Study officials:
affiliation: Smith & Nephew, Inc.
name: Judth Horner
role: STUDY_CHAIR
References:
Clinical trial NCT03071367: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students
Official title: Title: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Activities
Keywords: Airway Management
Medical students
Intratracheal intubation
Educational Technology
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.


Eligibility criteria: Inclusion Criteria:

* Last year medical students at Universidad de los Andes
* Over 18 year old

Exclusion Criteria:

* Previous elective anesthesia rotation
* Motor deficit affecting the upper limbs

Primary outcomes:
measure: Airway management score
timeFrame: 28 days
Secondary outcomes:
measure: Successful intubation rate
timeFrame: 28 days
measure: Incidence of complications
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00711867: Comparison of Intraoperative Warming Devices
Official title: Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Dynatherm Medical Inc.
First posted: 2008-07-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.


Eligibility criteria: Inclusion Criteria:

* Initial total knee arthroplasty.
* Expected duration of surgery at least 2 hours.
* General anesthesia.
* American Society of Anesthesiologists (ASA) classification I-III.
* Age \>= 18 years.

Exclusion Criteria:

* Skin abrasion at the device application site.
* History of peripheral vascular disease.
* History of allergic skin conditions of the upper extremities.
* History of malignant hyperthermia.

Primary outcomes:
measure: Sublingual Temperature.
timeFrame: Within 10 minutes of arrival in PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kent Weinmeister, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trentman TL, Weinmeister KP, Hentz JG, Laney MB, Simula DV. Randomized non-inferiority trial of the vitalHEAT temperature management system vs the Bair Hugger warmer during total knee arthroplasty. Can J Anaesth. 2009 Dec;56(12):914-20. doi: 10.1007/s12630-009-9199-2. Epub 2009 Sep 25.
Clinical trial NCT06684067: Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.
Official title: A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Patient Navigation
Keywords: RCT
colorectal cancer screening
patient navigation
Malaysia
depression
anxiety
HADS
GHQ12
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2024-11-12
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question\[s\] it aims to answer are:

Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?

Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?

Participants in the intervention arm will receive:

* standard clinic instructions for the colonoscopy
* phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure
* a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital
* a direct line for phone calls to patient navigators for further guidance on overcoming barriers

Participants in the control arm will only receive:

* standard clinic instructions for the colonoscopy
* one phone call from the patient navigator to discuss the colonoscopy procedure


Eligibility criteria: Inclusion Criteria:

* Average risk for CRC
* More than 50 years of age
* Capacity for informed consent
* IFOBT positive

Exclusion Criteria:

* Moderate or high risk CRC
* Previous CRC screening
* Symptomatic

Primary outcomes:
measure: Colonoscopy completion rate
timeFrame: 90 days
Secondary outcomes:
measure: Mental health - anxiety and depression
timeFrame: 90 days
measure: Mental health - General psychological distress
timeFrame: 90 days
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Medicine, Universiti Malaya
state: Federal Territory
Study officials:
affiliation: Universiti Malaya
name: April C Roslani, Master of Surgery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06741267: The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment
Official title: The Assessment of the Feasibility and Operational Performance of Automated System Bronchoscopy in a Simulated Environment: a Multicenter, Randomized-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Compare Operational Performance of Three Technology in Lung Models
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Recruit 30 trainee physicians from 6 centers and compare their performance in operating lung models using automatic bronchoscopy, robotic bronchoscopy, and electromagnetic navigation bronchoscopy.


Eligibility criteria: Inclusion Criteria:

1. The recruited participants were respiratory internal medicine trainees undergoing further training.
2. They were willing to undertake relevant training and complete the experiment persistently -

Exclusion Criteria:

If the participant has any previous clinical or simulated experiences involving electromagnetic navigation bronchoscopy, robotic bronchoscopy system, or fluoroscopy bronchoscopy, they will be excluded.

-

Primary outcomes:
measure: Sampling time
timeFrame: During the bronchoscopy
Secondary outcomes:
measure: Total time
timeFrame: During the bronchoscopy
Other outcomes:
Locations:
city: Guangzhou
country: Chad
facility: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
state: Guangdong
Study officials:
References:
citation: Cold KM, Xie S, Nielsen AO, Clementsen PF, Konge L. Artificial Intelligence Improves Novices' Bronchoscopy Performance: A Randomized Controlled Trial in a Simulated Setting. Chest. 2024 Feb;165(2):405-413. doi: 10.1016/j.chest.2023.08.015. Epub 2023 Aug 23.
Clinical trial NCT01200667: uPHI: Wireless Body Area Network Core Technology
Official title: uPHI: Wireless Body Area Network Core Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asystole
Sinus Bradycardia
Sinus Tachycardia
Sinus Arrhythmia
Atril Fibrillation
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 380
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Emergency patient with chest pain.
* Emergency patients were implementation of 12-lead EKG during observation.
* Out-patient services of Cardiology with arrhythmia.
* Adults over 20 years old.

Brief summary: The application scenario is shown in the figure below: the user utilizes an ECG-based wireless sensor (WiBoC Chipset), and transmit those signals to a mobile-phone device that has an embedded expert system integrated. With the aid of 3G system, a remote healthcare monitoring center receives those uploaded signals and stores into the application server. According to the events from this server, the people on service responses to the emergency and takes the corresponding process.


Eligibility criteria: Inclusion Criteria:

* Emergency patient with chest pain.
* Emergency patients were implementation of 12-lead EKG during observation.
* Out-patient services of Cardiology with arrhythmia history.
* Adults over 20 years old.

Exclusion Criteria:

* The patient required the intervention of resuscitation and cardiac massage.
* Chest trauma
* On pacemaker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ray-Jade Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575067: Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-42cm)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: BP
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 85
Sex: ALL
Minimum age (years): 30
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resident of a community

Brief summary: The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-42 cm.


Eligibility criteria: Inclusion Criteria:

* cuff circumference: 22cm-42cm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05703867: Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration
Official title: Interventional Study of Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age-Related Macular Degeneration
Nonexudative Age-related Macular Degeneration
Lead sponsor: Jarding, John, OD
Sponsor class: INDIV
Collaborators: name: Professor Timothy Jackson, King's College
name: i-Lumen Scientific, Inc.
First posted: 2023-01-30
Enrollment: 404
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration.

Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.


Eligibility criteria: Inclusion Criteria:

* Adults aged at least 50 years with dry AMD in at least one eye

Exclusion Criteria:

* Eye diseases other than dry AMD
* Implanted electrical devices
* Seizure disorders

Primary outcomes:
measure: Mean logMAR BCVA
timeFrame: Week 1
Secondary outcomes:
measure: Proportion of improved, stable or worsened BCVA
timeFrame: Week 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01858467: Supreme LMA and Endotracheal Intubation Use in Caesarean Section
Official title: Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Keywords: Airway, Cesarean
Lead sponsor: QuanZhou Women and Children's Hospital
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
First posted: 2013-05-21
Enrollment: 920
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.

The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.

Detailed description: We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 50 years old
* ASA 1 or 2
* Fasted at least 6 hours
* Weight 40 to 75kg
* Normal airway assessment
* Singleton term pregnancy (\>36weeks)
* Elective Caesarean section

Exclusion Criteria:

* In labour
* Body mass index \>35
* Difficult airway (Mallampati 4 or abnormal airway assessment)
* Gastrooesophageal reflux disease

Primary outcomes:
measure: First attempt insertion success rate
timeFrame: 1 hour
Secondary outcomes:
measure: Time to effective airway placement
timeFrame: 1 hour
measure: Aspiration
timeFrame: 1 hour
measure: blood on SLMA on removal
timeFrame: 1 hour
measure: Sore Throat
timeFrame: 1 hour
measure: Patient satisfaction
timeFrame: 1 hour
measure: Regurgitation
timeFrame: 1 hour
measure: Seal pressure
timeFrame: 1 hour
measure: Gastric aspirate
timeFrame: 1 hour
measure: Neonatal outcomes
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Quanzhou Women's and Children's Hospital
name: Shi Y Li, MD
role: STUDY_DIRECTOR
References:
citation: Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.
Clinical trial NCT03811067: Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
Official title: Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Transversus abdominis plane block
Rectus sheath block
Cesarean delivery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. Many regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.


Eligibility criteria: Inclusion Criteria:

ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks

Exclusion Criteria:

obesity (body mass index \>35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy

Primary outcomes:
measure: Morphine consumption
timeFrame: Postoperative 24th hour.
measure: NRS score
timeFrame: Postoperative 24th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Hadi Ufuk MD Yörükoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03200067: Effects on the Personalized Rehabilitation Service in Patients With Cancer
Official title: Effects on the Personalized Rehabilitation Service in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Cancer Female
Lymphedema
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching).


Eligibility criteria: Inclusion Criteria:

* Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user

Exclusion Criteria:

* Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program

Primary outcomes:
measure: Patient health ability change
timeFrame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Secondary outcomes:
measure: Lab test result change
timeFrame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
measure: Patient satisfaction change on mobile service
timeFrame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
measure: Patient satisfaction change on healthcare management
timeFrame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Eunjoo Yang, PhD
role: STUDY_CHAIR
References: