louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03429712: Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications
Official title: Patient- and Task-specific Radiation Dose Optimization for Pediatric Abdominopelvic CT Applications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Split Dose CT
Keywords: CT Scan
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 19
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Radiation dose reduction has been a primary driver of technology development in multi-detector computed tomography (MDCT). The optimization of radiation dose for patient and task specific computed tomography (CT) applications continues to be an ongoing challenge, especially in pediatric patients where the desire to reduce radiation dose to lowest possible levels leads to both positive and negative effects. A novel research tool on the Siemens dual source (Flash® and Force ®) CT scanners allows one to assess multiple tube current levels from a single CT acquisition without incurring additional dose to the patient. Tube current is a primary contributor to radiation dose and image noise, which are inversely related. This is achieved by independently adjusting the current of each tube, while maintaining same kV in each x-ray tube. Moreover, Duke's medical physics team has developed a method based on mathematical expressions that allows the creation of incremental dose levels from the acquired image data sets. This innovative and powerful tool can be used to compare diagnostic accuracy, detectability, and many more relevant clinical features amongst multiple tube current levels with the attainment of a single CT acquisition.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Image Noise
timeFrame: Up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniele Marin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622712: Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device
Official title: Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Inguinal Hernia
Keywords: inguinal hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medri
First posted: 2012-06-19
Enrollment: 235
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.

Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.


Eligibility criteria: Inclusion Criteria:

* elective repair for a primary unilateral inguinal hernia OR
* elective repair for a recurrent unilateral inguinal hernia after non-mesh repair

Exclusion Criteria:

Primary outcomes:
measure: Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Pain assessment.
timeFrame: after 1 year
measure: Discomfort assessment.
timeFrame: after 1 year
measure: Use of oral analgetics.
timeFrame: after 1 year
measure: Wound morbidity.
timeFrame: after 4 weeks
measure: Recurrence of hernia.
timeFrame: after 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04994912: First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
Official title: Title of Study: A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.

Detailed description: To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers

To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female 18 to ≤ 55 years old at the time of consent.
2. Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.

Exclusion Criteria:

1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments.
2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.

Primary outcomes:
measure: safety assessment
timeFrame: Day 1
measure: safety assessment
timeFrame: Day 1
measure: safety assessment
timeFrame: Day 1
Secondary outcomes:
measure: PK assessment
timeFrame: Day 1
measure: PK assessment
timeFrame: Day 1
measure: PK assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
Study officials:
References:
Clinical trial NCT06834412: A Study Evaluating the Value of 68Ga-Pentixafor PET Imaging in the Staging of Hematological Tumor, and Comparing It with 18F-FDG PET/CT Imaging
Official title: [68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematological Malignancies
Keywords: 68Ga-Pentixafor
hematological malignancies
18F-FDG
staging
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: before-after study in the same patient
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.


Eligibility criteria: Inclusion Criteria:

Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.

Exclusion Criteria:

Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase \> 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs

Primary outcomes:
measure: Maximum Standardized uptake value (SUVmax)
timeFrame: 1 day from injection of the tracer
measure: Mean Standardized Uptake Value(SUVmean) of liver
timeFrame: 1 day from injection of the tracer
measure: Mean Standardized uptake value (SUVmean)
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT05365412: Clinicopathological Characteristics of Colon Cancer in Young Age
Official title: Clinicopathological Characteristics of Colon Cancer in Young Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colo-rectal Cancer
Molecular Pathway Deregulation
Keywords: colorectal cancer
prognosis
sex difference
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 1400
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: Patients treated after being diagnosed with colorectal cancer, and agreed to participate

Brief summary: A Study on the Characteristics of Colorectal Cancer by Age and sex.

Detailed description: The investigators aimed to investigate the prognosis according to sex and age by analyzing the clinical, pathophysiological, and molecular characteristics of colorectal cancer (CRC), and to find the factors influencing the prognosis of CRC.

Eligibility criteria: Inclusion Criteria:

* Patients treated after being diagnosed with colorectal cancer

Exclusion Criteria:

* Patients under age of 18 years, or patients who cannot choose whether to participate or not
* Patients who refuse to participate in the study

Primary outcomes:
measure: Survival (overall/disease-specific) according to sex, molecular profiles and sex hormone receptors
timeFrame: From date of enrollment until the date of death from colorectal cancer or from any cause, assessed up to 120 months
Secondary outcomes:
measure: Disease-free survival according to sex, molecular profiles and sex hormone receptors
timeFrame: From date of enrollment until the date of first documented recurrence of colorectal cancer, assessed up to 120 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02444312: Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study
Official title: A Randomised Controlled Trial of Benefit Finding in Caregivers: The Building Resources in Caregivers (BRiC) Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Psychological Distress
Keywords: Caregiving
Benefit Finding
Writing Intervention
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Carolan Research Institute
name: Care Alliance Ireland
First posted: 2015-05-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial that will compare the effects of a brief benefit -finding writing intervention with an active control condition on quality of life and psychological health among informal caregivers.

Detailed description: A double-blind, randomized controlled parallel group study design with an equal 1:1 allocation ratio will be employed. This study will compare the effect of a brief benefit finding writing intervention with a control condition among caregivers. Caregivers currently caring for people with mental and physical disabilities will be randomised into a two-week, a) a benefit writing group or b) a control writing group. Caregivers will complete self-report measures relating to their care-recipient and themselves (e.g., illness type, and sociodemographics) and psychometric measures of benefit finding (primary outcome), psychological distress and quality of life(secondary outcomes). These will be assessed via online software at baseline, immediate post-test and at 3 month follow-up. Additionally, expectations and fidelity indices will be assessed and qualitative commentary on participation experiences gathered.

Eligibility criteria: Inclusion Criteria:

* Must be over the age of 18
* Must identify as caring for a family member, friend or relative
* Must be living in Ireland

Exclusion Criteria:

* If the person cared for is living in institutional care

Primary outcomes:
measure: Benefit Finding (Adapted version of the 17-item Benefit Finding Scale; Antoni et al., 2001)
timeFrame: Baseline, immediate post-intervention (two weeks), and 3 months
Secondary outcomes:
measure: Caregiver Quality of Life (40 item Adult Carer Quality of Life Questionnaire; Joseph, Becker, Elwick, & Silburn, 2012)
timeFrame: Baseline, immediate post-intervention (two weeks), and 3 months
measure: Psychological Distress (Hospital and Anxiety Depression Scale; Zigmond & Snaith, 1983)
timeFrame: Baseline, immediate post-intervention (two weeks), and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Limerick, Department of Psychology
name: Stephen Gallagher, PhD
role: STUDY_DIRECTOR
affiliation: University of Limerick
name: Charles Brand, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Limerick
name: Brenda H O' Connell, B.A
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05010512: Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Official title: Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Ametropia
Myopia
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Detailed description: Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Eligibility criteria: Key Inclusion Criteria:

* Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
* At least 3 months of contact lens wearing experience;
* Less than or equal to 0.75 diopter (D) astigmatism in each eye;
* Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
* Monovision and/or multifocal lens wearer;
* Routinely sleeps in habitual contact lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance VA (logMAR) With Study Lenses
timeFrame: Day 8 (-0/+3), each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Alcon Investigator 6355
state: Florida
city: Tallahassee
country: United States
facility: Alcon Investigator 6418
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigator 3950
state: Illinois
city: Franklin Park
country: United States
facility: Alcon Investigator 6614
state: Illinois
city: Eden Prairie
country: United States
facility: Alcon Investigator 6583
state: Minnesota
city: Wyomissing
country: United States
facility: Alcon Investigator 3382
state: Pennsylvania
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigator 2786
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06335212: Peripheral Defocus Profile of Multifocal Minus Contact Lenses
Official title: Peripheral Defocus Profile of Multifocal Minus Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Refractive Errors
Contact Lens
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults between 18 and 30 years of age.

Brief summary: Purpose: Numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. It has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. As such, multifocal soft contact lenses (MFCLs) have been utilized for myopia control in school-aged children, with variable efficacies. One potential explanation is that the actual peripheral myopic defocus an eye experiences during MFCL wear may not be identical to the Add power and not sufficient to reduce myopia progression. Our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (SVCLs) and MFCLs of different Add powers.

Methods: Subjects with -1.00 D to -10.00 D of myopia (SE, determined with manifest refraction) were custom fit with both single vision (SV) and MFCLs (+2.00 and +4.00 D Add; provided by Specialeyes) in both eyes. These Specialeyes MFCLs had an aspheric design with a standard total optical zone of 8.0mm. Cycloplegic central autorefraction was conducted with both Grand Seiko WAM-5500 open-field auto-refractor (Grand Seiko Co Ltd) and OPD OPD-Scan III Wavefront Aberrometer (Marco) on the subjects in the following conditions: (1) no CLs, (2) SVCLs, (3) MFCLs (+2.00D Add), and (4) MFCLs (+4.00D Add). Relative peripheral power profiles were measured using the OPD under the same 4 conditions after cycloplegia. Data in the right eye was used for analysis.


Eligibility criteria: Inclusion Criteria:

* 18-30 years of age
* spherical equivalent (determined with subjective refraction) between -1.00 and -10.00 D in each eye, spherical power between -0.75 and -10.00 D and cylindrical power ≤ 1.50 D
* monocular best corrected visual acuity 20/25 or better
* no previous contact lens experience required
* no history of ocular pathology, binocular vision anomalies, or refractive surgery.

Exclusion Criteria:

-

Primary outcomes:
measure: refractive power
timeFrame: Relative pupil limited optical power profile was measured once within one month from their first visit when the subjects were uncorrected or wearing contact lenses of various designs
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York, College of Optometry
state: New York
Study officials:
References:
Clinical trial NCT03068481: Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
Official title: A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
Primary purpose: OTHER

Brief summary: The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594.

The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer part

  * Healthy Japanese males aged 20 to 35 years, inclusive
* Patient part

  * Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  * Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
  * Male patients with Parkinson's disease aged 20 to 74 years inclusive, post-menopausal female patients with Parkinson's disease aged 50 to 74 years inclusive

Exclusion Criteria:

* Healthy volunteer part

  * Subjects with any abnormal findings in physical examination vital signs, 12-lead ECG, clinical laboratory tests, ophthalmic examinations and electroencephalography
* Patient part

  * Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
* Healthy volunteer part and patient part

  * Subjects who do not agree to avoid dangerous works such as driving, mechanical operation and high-place work until completion of the follow-up examination

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Up to 15 days after last administration
measure: Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
timeFrame: Up to 336 hours after last administration
measure: Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
timeFrame: Up to 336 hours after last administration
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)
timeFrame: Up to 336 hours after last administration
Other outcomes:
Locations:
city: Kyushu And Other Regions
country: Japan
Study officials:
References: