louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06037343: Deep Learning Image Reconstruction for Abdominal CT of Hepatocellular Carcinoma Compared With 3-TESLA MRI
Official title: Deep Learning Image Reconstruction for Abdominal CT of Hepatocellular Carcinoma Compared With 3-TESLA MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
DLIR CT
ASIR reconstruction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults undergoing a CT and a MRI for detection or following of an HCC during the same week

Brief summary: New algorithms for processing CT acquisitions, based on artificial intelligence, have been reported to improve acquisition quality. Thats' why it's possible to imagine that new scan post-processing algorithms enable better detection and characterization of hepatocellular carcinoma lesions than with standard reconstructions. DLIR reconstructions could even match with MRI detection.

The aim of the study is to compare the detection and characterization of hepatic lesions according to the LI-RADS classification in CT with DLIR artificial intelligence reconstruction, compared with ASIR-V reconstruction and the gold standard of MRI.


Eligibility criteria: Inclusion Criteria:

* undergoing CT and MRI scans in the same week, with protocols dedicated to the detection of HCC lesions

Exclusion Criteria:

* imaging with radiological artefact

Primary outcomes:
measure: Lesion size in mm
timeFrame: Through study completion, an average of 1 year
measure: Hypervascular appearance of lesion
timeFrame: Through study completion an average of 1 year
measure: Hypervascular capsule
timeFrame: Through study completion an average of 1 year
Secondary outcomes:
measure: Infiltrative nature Classification of the hepatic lesion by LI-RADS in MRI
timeFrame: Through study completion an average of 1 year
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT06745843: Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study
Official title: Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Keywords: health literacy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Gelre Hospitals
First posted: 2024-12-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to investigate digital health literacy in liver cirrhosis patients.

Participants will fill in two questionnaires by email or mail.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
* Age 18 years or older
* Treated at Gastroenterology department

Exclusion Criteria:

* Objection to be approached for scientific studies requests, documented in electronic patient record

Primary outcomes:
measure: Digital Health Literacy Instrument 2.0 scores
timeFrame: At time of enrollment, single point in time.
measure: Number of right answers on digital health visualization questionnaire.
timeFrame: At time of enrollment, single point in time.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University Medical Center
name: Tom Gevers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06569043: Appetite Responses to Breakfast Bar Product
Official title: Appetite Responses to Breakfast Bar Product: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Consumer
Lead sponsor: General Mills
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-70 years
* Habitual snack bar consumers (at least several times per month)
* Body mass index 18.5-29.9 kg/m2 (based on self-reported weight and height)
* Understand and willing to follow the study procedures
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
* Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day
* Willing to provide informed consent to participate in the study

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivities, or intolerance to any food or food ingredients
* Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medications that affect appetite, metabolism or blood pressure
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with an eating disorder
* Restraint eaters as determined by a score \>4 from the Dutch Eating Behavior Questionnaire
* Lost or gained 5 or more pounds in the past 3-months
* On a weight loss diet or undergoing intermittent fasting
* COVID-19 infection within the past 3 months
* Subjects who do not eat bar products

Primary outcomes:
measure: Visual Analogue Scale for Hunger 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Fullness 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Satiation 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Desire to Eat 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Prospective Consumption 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Satisfaction 0-240 minutes
timeFrame: 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Remote
state: Minnesota
Study officials:
References:
Clinical trial NCT03774043: Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI
Official title: Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.


Eligibility criteria: Inclusion Criteria:

1. Spinal cord lesion at level of C3 to T1
2. Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
3. Individuals must be at least 6 months status post injury
4. Individuals must be between the ages of 18-70 years inclusive, male or female
5. Spinal cord injury must be secondary to a non-progressive etiology
6. Individuals must be medically stable.
7. Able to comply with protocol/study requirements
8. Not currently (\>2 weeks) taking any medications for spasticity management.

Exclusion Criteria:

1. Recent change in the use of narcotic, anti-inflammatory or pain medication
2. Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
3. History of sleep apnea
4. Active participation in another movement research study or therapy program
5. Anti-spasticity drug injection less than 3 months, prior to beginning treatment
6. Musculoskeletal pain that interferes with participation in study
7. Women who are currently, may be or planning on becoming pregnant

Primary outcomes:
measure: Change in grip strength
timeFrame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
measure: Pinch Strength
timeFrame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
measure: 9 Hole Peg Test
timeFrame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
measure: Box and Blocks test
timeFrame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT03971838: Diabetes Prevention Programming for Women With a History of Gestational Diabetes
Official title: Diabetes Prevention Programming for Women With a History of Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate.

Detailed description: The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. There are two potential types of participants:

1. Women and their children 10+ can consent to participate in the diabetes prevention programming offered through Dr. Hannon's center (called Encourage). Researchers will collect data at three time points, baseline, 4-6 months, and 12 months.
2. Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.

Eligibility criteria: Inclusion Criteria:

* History of gestational diabetes in a previous pregnancy
* Age 18+

Exclusion Criteria:

·Currently pregnant

Primary outcomes:
measure: Enrollment and participation rates in a diabetes prevention intervention
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
References:
Clinical trial NCT05292638: Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
Official title: A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glabellar Lines
Lead sponsor: CKD Bio Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active-controlled
Primary purpose: TREATMENT

Brief summary: A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.


Eligibility criteria: Inclusion Criteria:

* Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)

Exclusion Criteria:

* Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
* History of facial nerve paralysis or ptosis
* Significant facial asymmetry
* Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
* Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
* Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: up to week 12
Secondary outcomes:
measure: Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit
timeFrame: Week 4, 8, 12
measure: Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit
timeFrame: Week 4, 8, 12
measure: Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit
timeFrame: Week 4, 8, 12
measure: Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit
timeFrame: Week 4, 8, 12
measure: Subject-assessed satisfaction scale at each follow-up visit
timeFrame: Week 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: beomjoon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05998538: Patients With Higher BMI Produces More Postoperative Drainage Volume and Length of Stay in Cross-Sectional Study
Official title: Patients With Higher BMI Produces More Postoperative Drainage Volume and Longer Length of Stay in Cross-Sectional Study: a Comparison of Total vs Partial Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical records of patients who underwent primary TKA and UKA between December 2019 and October 2022

Brief summary: Partial knee arthroplasty theoretically produces less blood loss compared to total knee arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the most commonly impacted medial knee. This study compared the postoperative drainage volume and length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.

Detailed description: Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps sparing muscle approach, persistence of cruciate ligaments, and less femorotibial dislocation.7 However, studies investigating drainage volume in UKA are still limited. In this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated several parameters that contributed the production. This study has not received any funding or grant.

Eligibility criteria: Inclusion Criteria:

* grade 4 Osteoarthritis

Exclusion Criteria:

* previous trauma
* infection
* blood coagulation disorder

Primary outcomes:
measure: Drainage Volume
timeFrame: 3-5 days post op
Secondary outcomes:
measure: LOS
timeFrame: pre-op until drainage removed, 3-6 days post op
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Pondok Indah Hospital
Study officials:
affiliation: Indonesia University
name: Ismail H Dilogo, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04799938: Effect of Exercise on GDF-15 Levels in Prediabetic Patients
Official title: Effect of Exercise on GDF-15 Levels in Prediabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Keywords: GDF-15
Physical Exercise
Prediabetes
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercise intervention will be applied to intervention group All participiants will be applied to standard recommendations
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate whether there is a change in GDF-15 levels in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program with guide-based exercise programs.

Detailed description: GDF-15, which has anorexigenic effects, increases with exercise. In prediabetic patients, GDF-15 is higher than healthy controls. The effect of exercise on GDF-15 levels in prediabetic patients is unknown.

The aim of this study is to evaluate whether there is a change in GDF-15 levels after the application of guideline-based exercise programs in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program.

Eligibility criteria: Inclusion Criteria:

* Body mass index 30-34.9 kg / m2
* Sedentary life-style (Physical activity below 300 kcal / day will be assessed by Minnesota Leisure Physical Activity Questionnaire)
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by face-to-face interview by the researchers)
* Having the same weight for 6 months before participating in the study (± 2.5 kg)
* Those diagnosed with prediabetes by oral glucose tolerance test and / or HbA1c measurement will be included.

Exclusion Criteria:

* Serious medical condition (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having cardiovascular disease
* Having diabetes
* Using metformin
* Taking hormone replacement therapy
* less than 1 year life expectancy
* HIV positivity
* Substance use
* Functional dependence
* Cognitive weakness
* Those with other diseases that will affect the study result (respiratory diseases, muscle diseases, etc.)
* Those who use drugs or supplements that will affect the results of the study

Primary outcomes:
measure: Level of Growth Diferantiation Factor-15
timeFrame: 12 weeks
Secondary outcomes:
measure: Level of VO2max
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Han Training and Research Hospital
Study officials:
affiliation: Sultan Abdülhamid Han Training and Rsearch Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651638: A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype
Official title: A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK and safety profile of ARQ 197
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype

Detailed description: This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197

Eligibility criteria: Inclusion Criteria:

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Exclusion Criteria:

* Subject must provide written informed consent prior to any study related procedures
* Subjects must be between the ages of 18 and 65 years old
* Male participants must be surgically sterilized
* Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
* Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Primary outcomes:
measure: To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
timeFrame: May 2008
Secondary outcomes:
measure: To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197
timeFrame: May 2008
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Indiana
Study officials:
affiliation: Covance Clinical Research Unit
name: Ronald Kimberlin, MD
role: PRINCIPAL_INVESTIGATOR
References: