louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04981223: Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Official title: Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.


Eligibility criteria: Inclusion Criteria:

* Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
* Agree to consent to the study

Exclusion Criteria:

* Does not agree to consent.

Primary outcomes:
measure: Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
timeFrame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
Secondary outcomes:
measure: Prostate Cancer Border Identification Post-Prostatectomy
timeFrame: 3 years
measure: Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
timeFrame: 1 year and 10 months
measure: Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
timeFrame: 1 year and 10 months
measure: Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
timeFrame: 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Geoffrey Sonn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou SR, Choi MH, Vesal S, Kinnaird A, Brisbane WG, Lughezzani G, Maffei D, Fasulo V, Albers P, Zhang L, Kornberg Z, Fan RE, Shao W, Rusu M, Sonn GA. Inter-reader Agreement for Prostate Cancer Detection Using Micro-ultrasound: A Multi-institutional Study. Eur Urol Open Sci. 2024 Jul 13;66:93-100. doi: 10.1016/j.euros.2024.06.017. eCollection 2024 Aug.
Clinical trial NCT03975023: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Official title: Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Traumatic Brain Injury
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
Collaborators: name: HealthTech Connex Inc.
First posted: 2019-06-05
Enrollment: 52
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 70 hockey players aged 14-25 years will be included in the study.

Brief summary: Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity.

The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.


Eligibility criteria: Inclusion Criteria:

* Any sex, 14-25 years old inclusively
* Attending the Creative Artists Agency LLC (CAA) hockey camp in July 2019
* Able to understand the informed consent/assent form, study procedures and willing to participate in study

NeuroCatch Platform-Specific Inclusion Criteria

* Able to remain seated and focused for 6 minutes
* Normal hearing capabilities

Exclusion Criteria:

• Unable to provide informed consent

NeuroCatch Platform-Specific Exclusion Criteria

* Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
* In-ear hearing aid or cochlear implant, hearing device
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device during hockey camp (July 7th - 13th 2019)
* Not proficient in English
* Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
* History of seizures
* Allergy to rubbing alcohol or EEG gel
* Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Primary outcomes:
measure: ERP response size
timeFrame: 1 week
measure: ERP response timing
timeFrame: 1 week
measure: Eye-tracking: target accuracy
timeFrame: 1 week
measure: Eye-tracking: speed
timeFrame: 1 week
Secondary outcomes:
measure: Cognitive tests
timeFrame: 1 year
measure: Balance
timeFrame: 1 week
Other outcomes:
measure: Trends between outcome measures and demographics will be explored
timeFrame: 1 year
Locations:
city: Cape Cañaveral
country: United States
facility: The Carrick Institute
state: Florida
Study officials:
References:
Clinical trial NCT01813123: A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Official title: A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse Prevention
Keywords: gender-specific
web-based
drug abuse
prevention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-03-18
Enrollment: 788
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions.

The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.


Eligibility criteria: Inclusion Criteria:

* resident of USA
* speaks English
* have private computer with Internet

Exclusion Criteria:

-

Primary outcomes:
measure: 30-day alcohol and drug use
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Social Work
state: New York
Study officials:
affiliation: Columbia University
name: Traci M Schwinn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06585423: Tolerability of an Anesthesia-free Tonometer Tip
Official title: Tolerability of an Anesthesia-free Tonometer Tip
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intraocular pressure (IOP) measurements using 3 different prototype tips. All standard equipment used to perform Goldmann Applanation Tonometry will be used with the only difference being the applanator tip. The 3 different prototypes are as follows and would be tested in random order:

1. - Medical grade acrylic tip covered by a sterile commercially available bandage contact lens (Air Optix, Night and Day Contacts, Alcon). The bandage contact lens will be changed between subjects and the underlying acrylic tip sterilized per standard clinical procedure (bleach soak followed by soak and rinse in sterile water).
2. - Medical grade acrylic tip coated with medical grade silicone of a thickness \&lt; 100 µm. This tip will be sterilized per standard clinical procedure between subjects
3. - Medical grade acrylic tip coated with medical grade silicone of a thickness \&gt; 100 µm. This tip will be sterilized per standard clinical procedure between subjects.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.


Eligibility criteria: Inclusion Criteria:

* Presenting for a routine eye exam
* ≥ 18 years of age
* Able and willing to give consent

Exclusion Criteria:

* History of corneal scarring
* Active infection of the eye
* History of alternated corneal sensitivity
* History of corneal surgery

Primary outcomes:
measure: Patient tolerability rating of different tips
timeFrame: Baseline
measure: Patient comfort rating of different tips
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
References:
Clinical trial NCT02689323: TMS Modulation of Insula-related Brain Networks
Official title: TMS Modulation of Insula-related Brain Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.


Eligibility criteria: Inclusion Criteria:

1. generally healthy
2. between the ages of 18-55
3. right-handed

Exclusion Criteria:

1. significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
2. current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
3. meet DSM-5 criteria for current substance use disorder other than nicotine
4. use of psychoactive medications that would result in a positive urine drug screen
5. Current use of medications known to lower the seizure threshold
6. positive breath alcohol concentration
7. presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
8. among women, a positive urine pregnancy test
9. vision that cannot be corrected to 20/40

Primary outcomes:
measure: Change in functional connectivity strength measured with functional magnetic resonance imaging
timeFrame: baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT03842423: Brachial Plexus Block in Children and Adolescents
Official title: Brachial Plexus Block in Children and Adolescents Requiring Surgery Following Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Fracture
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 2760
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the age of 18 who sustained an injury of the upper extremity requiring surgery and received brachial plexus anaesthesia.

Brief summary: This study involves a retrospective evaluation of brachial plexus anaesthesia in children and adolescents (patients under the age of 18) undergoing surgical procedures of the upper extremity following trauma. The investigators plan to recruit patients from our hospital patient database meeting our inclusion criteria. Observational period was defined between 1st of January 2002 and 31st of October 2018. Necessity to convert to general anaesthesia was defined as primary endpoint.


Eligibility criteria: Inclusion Criteria:

* Brachial plexus anaesthesia for surgical intervention of upper extremity injuries

Exclusion Criteria:

* age above 18

Primary outcomes:
measure: Conversion to general anaesthesia
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Zadrazil M, Opfermann P, Marhofer P, Westerlund AI, Haider T. Brachial plexus block with ultrasound guidance for upper-limb trauma surgery in children: a retrospective cohort study of 565 cases. Br J Anaesth. 2020 Jul;125(1):104-109. doi: 10.1016/j.bja.2020.03.012. Epub 2020 Apr 24.
Clinical trial NCT06879223: Effect of Oral Health Educational Program on the Oral Health Related Quality of Life in a Group of Children with Chronic Kidney Disease
Official title: Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life in a Group of Children with Chronic Kidney Disease: a Before and After Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Keywords: CKD OHRQL
OHEP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.


Eligibility criteria: Inclusion Criteria:

* Age 8-10 years old.
* Diagnosed with Chronic Kidney Disease

Exclusion Criteria:

* Children with other systemic diseases.
* Parents that refuse the participation of their children.

Primary outcomes:
measure: Oral health related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Developmental enamel defect.
timeFrame: 3 months
measure: Caries experience.
timeFrame: 3 months
measure: Caries experience
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unversity
Study officials:
References:
Clinical trial NCT03460223: Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis
Official title: Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Renal Cirrhosis
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney failure. The potential for stem cells to treat kidney failure was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function and alleviating renal injury in these patients. Therefore, the investigators propose a hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis patients, particularly reducing the decompensated conditions in these patients.

Detailed description: Kidney fibrosis represents the common pathway to end-stage kidney failure.The potential for stem cells to treat kidney failure was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, kidyney injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs (MSC) can improve the disease conditions in patients with kidney fibrosis. This study will also look at safety in these patients.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Glomerular sclerosis ratio ≤ 50%.
3. Renal tubulointerstitial fibrosis ratio ≤ 50%.
4. Negative pregnancy test.
5. Moderately active disease under standard treatment.

Exclusion Criteria:

1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.

Primary outcomes:
measure: BUN
timeFrame: 24 months
measure: Cr
timeFrame: 24 months
measure: eGFR
timeFrame: 24 months
measure: Cystatin C
timeFrame: 24 months
measure: Urine protein
timeFrame: 24 months
Secondary outcomes:
measure: Hb
timeFrame: 24 months
measure: Hct
timeFrame: 24 months
measure: Ca
timeFrame: 24 months
measure: P
timeFrame: 24 months
measure: ALT
timeFrame: 24 months
measure: PTH
timeFrame: 24 months
measure: VitD
timeFrame: 24 months
measure: ALB
timeFrame: 24 months
measure: TC
timeFrame: 24 months
measure: TG
timeFrame: 24 months
Other outcomes:
measure: Evaluation of renal fibrosis
timeFrame: 24 months
Locations:
Study officials:
affiliation: Nanjing Medical University
name: Jinhai Tang, M.D, PH.D
role: STUDY_CHAIR
References:
Clinical trial NCT04558723: Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Official title: Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-ischemic Dilated Cardiomyopathy
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2020-09-22
Enrollment: 760
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: Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.

Detailed description: The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.

Eligibility criteria: Inclusion Criteria:

* NIDCM (idiopathic or familial)\*
* LVEF ≤35% and presence of fibrosis on CMR
* Diagnostic CMR scan
* Age ≥18 years
* Written informed consent
* Ability to give informed consent

Exclusion Criteria:

* ICM \[previous myocardial infarction, previous percutaneous coronary intervention\]
* Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies \[e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy\], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies \[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\].
* Myocarditis
* Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
* Severe renal insufficiency (creatinine clearance \<30 mL/min)
* Current pacemaker or defibrillator in situ
* Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)
* Renal impairment defined as an eGFR \<30 milliliters
* Age \<18 years
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another randomized trial
* Life expectancy \<2 years

Primary outcomes:
measure: Death from any cause
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universität zu Lübeck
state: Schleswig-Holstein
Study officials:
affiliation: Medical Clinic II - University Heart Center Lübeck
name: Ingo Eitel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05146323: Optimization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging
Official title: Personalization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging With the Cardiofocal SmartZoom® Collimator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Myocardial SPECT
Sestamibi
SmartZoom
Cardiofocal collimator
Dose optimization
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with myocardial perfusion Imaging in the context of coronary heart disease

Brief summary: This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.


Eligibility criteria: Inclusion Criteria:

* Patient underwent stress-test 99 mTc-Sestamibi SPECT/CT myocardial perfusion Imaging on a Siemens Intevo Bold Anger camera with the cardiofocal SmartZoom® collimator

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of counts
timeFrame: Day 1
Secondary outcomes:
measure: Clinical evaluation
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References: