louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01323439: Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Official title: Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Keywords: Patients presenting with an intracranial aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
Collaborators: name: University of Florida
First posted: 2011-03-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment

Brief summary: This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

Detailed description: This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
* Information on data collection provided to the patient or legally authorized representative and signed informed consent.
* Aneurysm diameter ≤10mm .
* Age range of 18 - 90.

Exclusion Criteria:

* Aneurysm previously treated.
* Aneurysm AVM related or dissecting.
* Participation in a clinical investigation of other aneurysm treating or related devices.
* Any condition that would preclude the conduct of protocol follow-up.
* Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.

Primary outcomes:
measure: Anatomic occlusion of the aneurysm
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Safety during the procedure
timeFrame: Discharge, up to two years
measure: Safety post-procedure
timeFrame: 3-6 months follow-up
measure: Detachment system performance
timeFrame: During procedure
measure: Stability of embolization
timeFrame: 3-6 months follow-up
measure: Packing efficacy
timeFrame: 36- months follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT00035139: Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
Official title: Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Injuries
Keywords: pediatric traumatic brain injury
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Murray Fellowship
First posted: 2002-05-03
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among children and young adults. Deficits in attention and memory are common and persist for years after moderate or severe TBI. The similarity between these symptoms and those of children with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of methylphenidate in improving recovery of animals with brain injuries, support the need to study methylphenidate effects in children with TBI. This investigation of methylphenidate in children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different dosages of methylphenidate on attention and reaction time when the medication is administered to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to improve the rate of recovery of cognitive, memory, and attentional skills in children with TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.

Detailed description: During the first phase of the study which is of 8-days duration subjects will receive placebo on some days and methylphenidate on others. During this phase of the study the effects of the medication on children's performance on a computerized test of attention will be assessed. Individuals who do not have significant methylphenidate side effects during the first phase of the study will then participate in the second phase of the study. During the second phase subjects will receive either methylphenidate or placebo for 8 weeks. Neuropsychological measures of attention, memory, behavioral inhibition, cognitive flexibility, and motor performance will be obtained at baseline and after the 8 week medication trial in order to assess methylphenidate effects on the rate of recovery. Recovery will also be assessed using an interview measure of adaptive behavior and cognitive functioning. A stimulant medication side effect rating scale will be used to monitor for common methylphenidate adverse effects throughout both phases of the study

Eligibility criteria: Moderate to severe traumatic brain injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital Of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04546139: Feasibility of Smartphone-based Measurement on Badminton Footwork
Official title: Feasibility of Smartphone-based Measurement on Badminton Footwork
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Physical Therapy
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people who familiar with badminton six points foot work.

Brief summary: To evaluate the feasibility of a smartphone-based measurement on badminton footwork. The performance of footwork will be collected utilizing a smartphone app and further investigate the validity, reliability and discrimination of the measurement.


Eligibility criteria: Inclusion Criteria:

* adults familiar with badminton six points foot work.

Primary outcomes:
measure: inertial data of footwork performance
timeFrame: a week
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT03876639: Topical Application of Highly Concentrated Water-in-oil Emulsions
Official title: Topical Application of Highly Concentrated Water-in-oil Emulsions: Physiological Skin Parameters and Skin Penetration in Vivo - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Physiology
Dermal Administration
Emulsions
Keywords: Water-in-oil emulsion
Confocal Raman spectroscopy
Skin parameters
Tape stripping
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2019-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 I. determine the effect of repetitive application of newly developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal water loss and other physiological skin parameters and II. investigate the skin penetration of the model drug fluorescein sodium in tape stripping studies to determine the in vivo penetration profile from the water-in-oil emulsions.

Detailed description: Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant volar forearm of voluntary participants. Several physiological skin parameters will be monitored in weekly intervals during the application period. Additional measurements will be carried out immediately before the start of the application and after a treatment-free recovery period of 2 weeks. The untreated forearm will be used as a reference.

Subsequent to the observational study, tape stripping experiments with fluorescein sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.

Eligibility criteria: Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged between 18 and 65 years

Exclusion Criteria:

* Pregnancy
* Chronic skin conditions

Primary outcomes:
measure: Change in transepidermal water loss
timeFrame: 6 weeks
measure: Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT02510339: Tibial Shaft Nailing Treated With Suprapatellar Nailing
Official title: The Incidence of Associated Intra-articular Knee Pathology With Concomitant Tibial Shaft Fractures Treated With Suprapatellar Nailing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Broken Leg
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 16
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: The study population will include skeletally mature patients of Level One Orthopaedics, presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft.

Brief summary: The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.

Detailed description: Suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. Additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. An undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. Long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature.

The primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint.

As a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to Orlando Regional Medical Center.

Eligibility criteria: Inclusion Criteria:

1. skeletally mature
2. open or closed fractures of the tibial shaft

Exclusion Criteria:

1. concomitant tibial plateau or tibial pilon injuries
2. a knee dislocation
3. skeletally immature
4. those who will undergo standard (infra-patellar) tibial nailing

Primary outcomes:
measure: Consequences of suprapatellar tibial nailing
timeFrame: One year
Secondary outcomes:
measure: Incidences of intra-articular knee pathology
timeFrame: One year.
measure: Functional assessment
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Orlando Health IRB corporate manager
name: Tara Roberts, BS
role: STUDY_CHAIR
References:
Clinical trial NCT05623839: A Study of LY3305677 in Participants With Obesity Or Overweight
Official title: A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-11-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Week 20
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677
timeFrame: Predose up to 72 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677
timeFrame: Predose up to 72 hours postdose
measure: Pharmacodynamics (PD): Percentage change in Body Weight
timeFrame: Baseline through Week 20
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
city: Salt Lake City
country: United States
facility: ICON Early Phase Services Lenexa Center
state: Utah
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 NCT01522339: Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Official title: Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety of a Customized NICU MRI System
Keywords: NICU
MRI
Neonatal
Safety
Efficacy
Cincinnati
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the safety of a customized MRI scanner and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the Neonatal Intensive Care Unit (NICU) at Cincinnati Children's Hospital Medical Center (CCHMC).

Detailed description: The current practice of transferring infants from the Neonatal Intensive Care Unit (NICU) to radiology departments and imaging in adult-sized magnetic resonance imaging (MRI) scanners is associated with significant safety and image quality issues. For these reasons, the potential of MRI for diagnosing disease in neonates has yet to be fully realized. The overreaching goal of our research effort is to bring high-performance MRI into the NICU so that neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates. The purpose of this initial study is to determine the safety of the customized scanner installed in the NICU at Cincinnati Children's Hospital Medical Center (CCHMC) and gather preliminary data on image quality in a group of 10 medically stable infants admitted to the CCHMC NICU.

Eligibility criteria: Inclusion Criteria:

* Any infant admitted to the NICU at CCHMC
* Medically stable as per the opinion of the attending neonatologist currently on service
* Parental consent obtained

Exclusion Criteria:

* Infants too large to fit in the customized NICU MRI system comfortably (expected to be infants \>4.5 kg)
* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology

Primary outcomes:
measure: Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
timeFrame: Day 1
Secondary outcomes:
measure: MRI Image Quality
timeFrame: Post MRI Scan for Each Infant
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: NICU, Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Charles L Dumoulin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03870139: Cerebral and Peripheral Electrical Stimulation on Isometric Quadriceps Strength
Official title: Effects of Peripheral and Cerebral Electrical Stimulation on Maximal Isometric Strength of Knee Extensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Volunteers
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking.

This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.

Exclusion Criteria:

* Musculoskeletal or neurological disorder
* Under medication

Primary outcomes:
measure: Isometric quadriceps strength
timeFrame: Pre and Post-test (immediately after tDCS)
Secondary outcomes:
measure: Isometric quadriceps strength
timeFrame: During stimulation
measure: Isometric quadriceps strength
timeFrame: 10 minutes post-stimulation
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: Piauí
Study officials:
References:
Clinical trial NCT05722639: Evaluation of Accuracy and Consistency of the X-Trodes System
Official title: Evaluation of Accuracy and Consistency of the X-Trodes System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Equipment and Supplies
Keywords: Electrophysiology
Electrooculography
Electromyography
Electrocardiogram
Device
Acquisition
Lead sponsor: B-Cube
Sponsor class: OTHER
Collaborators: name: X-Trodes
First posted: 2023-02-10
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals ages 21 and over who are able to come to the study site and sit for about 30 minutes while two electrophysiology devices are capturing EEG, EOG, EMG, ECG signals from their body. Subjects should have no beard (to ease the signal capturing), not be pregnant, not suffer from sleep apnea, and comfortable with the study protocol (i.e., sign a consent form).

Brief summary: The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.

Detailed description: The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices (in measuring electroencephalography , electrooculography, electromyography, and electrocardiogram signals).

Subjects will wear both devices simultaneously while signals are captured in resting state. Following, an evaluation of the similarity of signals between the two devices will be conducted. The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device.

Eligibility criteria: Inclusion Criteria:

To be included in the study, subjects must meet all the following inclusion criteria:

* Adults (age 21 - 99)
* Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years
* Produce interpretable electrophysiological signals by the acquisition devices

Exclusion Criteria:

* Did not sign the informed consent
* Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area)
* Diagnosed as suffering from sleep apnea
* Pregnant or lactating women

Primary outcomes:
measure: Signals alignment between two devices
timeFrame: Within 3 months from the completion of data collection.
measure: Assessment of agreement among raters
timeFrame: Within 3 months from the completion of data collection.
Secondary outcomes:
Other outcomes:
measure: Subjects descriptive statistics
timeFrame: 1 month after completion of data collection.
measure: Signal descriptive statistics
timeFrame: 1 month after completion of data collection.
measure: Study descriptive statistics
timeFrame: 1 month after completion of data collection.
Locations:
city: Chicago
country: United States
facility: B-Cube
state: Illinois
Study officials:
References: