louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04777019: Computer Aided Polyp Detection (C3PO) Trial
Official title: Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Polyp
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 1000
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: Currently, the most commonly used quality marker in conventional colonoscopy (CC) is adenoma detection rate (ADR), which has been shown to inversely correlate with the incidence of CRC.3 Although colonoscopy is generally considered to be the most accurate screening modality, a substantial number of polyps are still missed. Hence population scheduled for a colonoscopy at either of the institution were part of the project.

Brief summary: Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.

Detailed description: Details regarding polyp size and location, morphology including Paris classification, optical assessment, and bowel preparation were prospectively collected and recorded in the online Redcap software. Final results of polyp histology were also collected. The video library was then independently reviewed for quality assessment by 3 experienced gastroenterologists. Videos that passed the initial quality assessment were then independently evaluated using the Discovery-AI system.

Aim of the study was to evaluate overall performance of Discovery-AI system for polyps of various size, morphology and pathology utilizing a prospectively developed video library.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
* Over 18 years of age

Exclusion Criteria:

* None if they qualify based on inclusion criteria
* Pregnant patients
* Inmate or prisoners
* Unable to provide informed consent

Primary outcomes:
measure: To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
References:
Clinical trial NCT00095719: Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Official title: A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia
Alzheimer's Disease
Keywords: Acute agitation in patients diagnosed with Dementia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-11-09
Enrollment: 125
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.


Eligibility criteria: Inclusion Criteria:

* Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia.

Exclusion Criteria:

* Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.

Primary outcomes:
measure: tolerability
Secondary outcomes:
measure: safety assessments
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Local Institution
state: California
city: Hamden
country: United States
facility: Local Institution
state: Connecticut
city: Hialeah
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: North Miami
country: United States
facility: Local Institution
state: Florida
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: New York
country: United States
facility: Local Institution
state: New York
city: Staten Island
country: United States
facility: Local Institution
state: New York
city: Dayton
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Hershey
country: United States
facility: Local Institution
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Midvale
country: United States
facility: Local Institution
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00760019: Inflammation and Vascular Function in Atherosclerosis
Official title: Inflammation and Vascular Function in Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atherosclerosis
Keywords: vascular inflammation
endothelium-dependent flow-mediated blood vessel function
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.

Detailed description: To test the hypothesis that inhibition of I \[kappa\] B kinase \[beta\] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.

Eligibility criteria: Inclusion Criteria:

* Non-smoking adult subjects with known atherosclerosis

Exclusion Criteria:

* Uncontrolled hypertension (\> 140/90 mmHg)
* Untreated hypercholesterolemia (LDL \> 160 mg/dL)
* Diabetes mellitus
* Alanine Aminotransferase \> 150
* Creatinine \> 1.4 mg/dL
* Concommitant use of warfarin

Primary outcomes:
measure: Flow-mediated, Endothelium-dependent Vasodilation
timeFrame: Upon completion of 4 weeks of salsalate and placebo treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Joshua A. Beckman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nohria A, Kinlay S, Buck JS, Redline W, Copeland-Halperin R, Kim S, Beckman JA. The effect of salsalate therapy on endothelial function in a broad range of subjects. J Am Heart Assoc. 2014 Jan 3;3(1):e000609. doi: 10.1161/JAHA.113.000609.
Clinical trial NCT00373919: The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagectomy
Postoperative Complications
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2006-09-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy.

Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence.

Design: This is a prospective, randomized, double blind, placebo controlled study.

Number of patients: 30.

Inclusion Criteria:

* Patients after trans-hiatal esophagectomy

Exclusion Criteria:

* Allergy to erythromycin
* Use of phenothiazine
* QT prolongation
* Liver function test (LFT) abnormalities
* Myasthenia gravis
* Cardiomyopathy


Eligibility criteria: Inclusion Criteria:

* Patients after trans-hiatal esophagectomy

Exclusion Criteria:

* Allergy to erythromycin
* Use of phenothiazine
* QT prolongation
* Liver function test (LFT) abnormalities
* Myasthenia gravis
* Cardiomyopathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaplan Medical Center
name: Koram Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03547219: Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Official title: Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Adolescent
Keywords: Depression
Adolescent
Biomarker
Inflammation
Brain-derived neurotrophic factor (BDNF)
Functional MRI
Antidepressant
Machine learning
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2018-06-06
Enrollment: 152
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of this study are to (1) identify inflammatory/neurotrophic and neurodevelopmental markers that predict antidepressant response and suicidal risk in depressed youth and (2) predict their treatment response and the occurrence of suicidal events at the individual level using machine learning approach.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of major depressive disorder(MDD) according to criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* current episode at least 4 weeks in duration at baseline
* with a score of at least 40 on the Children's Depression Rating Scale-Revised (CDRS-R), and CGI-Severity ≥4 at baseline

Exclusion Criteria:

* intelligence quotient (IQ) lower than 70
* psychotic features or first-degree relatives with a history of bipolar I disorder
* alcohol or substance abuse within the past 6 months
* history of schizophrenia, bipolar disorder, eating disorder, or autism
* history of neurological diseases including convulsive disorders or brain damage
* concurrent medications with psychotropic effects (other than stimulants for ADHD)
* chronic medical conditions (e.g., asthma, inflammatory bowel disease, diabetes) and/or chronic medication with psychotropic effects (e.g., anticonvulsants) or chronic use of NSAIDS or other drugs with known impact on inflammatory pathways.

Primary outcomes:
measure: the change from baseline in CDRS-R at week 8 or upon termination
timeFrame: baseline and 8 weeks or upon termination
Secondary outcomes:
measure: CGI-I at 8 weeks or upon termination
timeFrame: baseline and 8 weeks or upon termination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: N/A = Not Applicable
Study officials:
affiliation: Seoul National University and Seoul National University Hospital
name: Jae-Won Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi CH, Lee J, Lee KH, Hong SB, Kim SH, Han JY, Kim JW, Cho SC, Kim JW. Effects of Antidepressant Treatment on Symptom Measures of Attention in Adolescents with Depression: A Preliminary Open-Label Study. J Child Adolesc Psychopharmacol. 2021 May;31(4):288-293. doi: 10.1089/cap.2020.0101. Epub 2021 Jan 8.
Clinical trial NCT04315519: Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus
Official title: Investigation of the Effect of Blood Flow Restricted Aerobic Exercise on Cardiorespiratory Fitness and Blood Glucose in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Blood Flow Restricted Exercise
Type 2 Diabetes
Aerobic Exercise
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.

Detailed description: The aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .

Eligibility criteria: Inclusion Criteria:

* Having Type 2 Diabetes
* Not have been recruited any exercise programme for 6 months
* Volunteering to participate in the study

Exclusion Criteria:

* Nephropathy
* Retinopathy
* Have had myocardial infarction at least 6 months ago
* Stable or unstable angina pectoris
* The presence of peripheral artery disease
* Resting blood pressure above 160/100 mmHg
* Body mass index over 35 kg / m2
* History of deep vein thrombosis, pulmonary embolism or stroke

Primary outcomes:
measure: Blood Glucose
timeFrame: up to 12 months
measure: HbA1c
timeFrame: up to 12 months
measure: Blood Glucose in Oral glucose Tolerance Test
timeFrame: Up to 12 months
measure: Cardiorespiratory Fitness
timeFrame: Up to 12 months
Secondary outcomes:
measure: The Strength of Quadriceps Muscle
timeFrame: Up to 12 months
measure: Fat Free Mass
timeFrame: Up to 12 months
measure: The Strength of Hamstring Muscle
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02564419: Brain Machine Interface (BMI) in Subjects Living With Quadriplegia
Official title: Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2015-09-30
Enrollment: 1
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be

1. either processed in the Activa PC+S; or
2. off-loaded via the Nexus D communication device (Medtronic) to a computer.


Eligibility criteria: Inclusion Criteria:

* AIS Grades A \& B
* Level of Injury C5 or C6
* Local Community dwelling
* Stable chronic injury
* Stable health status and upper extremities
* Completion of Clinical Protocol 01

Exclusion Criteria:

* Coagulopathy
* Anticoagulation
* Pregnancy

Primary outcomes:
measure: AIS Motor Score
timeFrame: Up to 2 years
measure: AIS Sensory Score
timeFrame: Up to 2 years
measure: SF-36 scores
timeFrame: Up to 2 years
measure: Muscle Force Test
timeFrame: Up to 2 years
measure: Range of Motion
timeFrame: Up to 2 years
measure: SCIM III (Spinal Cord Independence Measure)
timeFrame: Up to 2 years
measure: JTT Hand Function Test
timeFrame: Up to 2 years
measure: Pinch Grip Strength
timeFrame: Up to 2 years
measure: Modified Ashworth Scale
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine/Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Jonathan R Jagid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis KC, Meschede-Krasa B, Cajigas I, Prins NW, Alver C, Gallo S, Bhatia S, Abel JH, Naeem JA, Fisher L, Raza F, Rifai WR, Morrison M, Ivan ME, Brown EN, Jagid JR, Prasad A. Design-development of an at-home modular brain-computer interface (BCI) platform in a case study of cervical spinal cord injury. J Neuroeng Rehabil. 2022 Jun 3;19(1):53. doi: 10.1186/s12984-022-01026-2.
Clinical trial NCT06985719: Effectiveness of Adapted Physical Activity Programs in Preventing Falls in People Aged Over 65
Official title: Effectiveness of Adapted Physical Activity Programs in Preventing Falls in People Aged Over 65: a Prospective Multicenter Study Carried Out Within the Maisons Sport Santé of Ile de France Departement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adapted Physical Activity
Lead sponsor: Centre Médical Porte Verte
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to target people aged over 65, considered to be at risk of falling.

Several methods have been validated in the existing literature to screen these patients. The chosen method is the Global Guide for Falls Prevention

Brief summary: The objective of this study is to evaluate the effectiveness of Adapted Physical Activity (APA) programs offered by Sport-Health Centers (MSS) in reducing the risk of falls in the elderly.

Detailed description: The effectiveness of adapted physical activity in preventing falls will be assessed by the evolution of SPPB before and after APA.

Evaluate the impact of APA on physical tests such as the UGT, the single-legged support test, to predict the risk of falling.

- Evaluate the impact of APA on risk factors associated with the risk of falling, such as fear of falling, overall perception of one's health, and depression.

All tests will be assessed at baseline and at the final visit 3 months after APA

Eligibility criteria: Inclusion Criteria:

* People at risk of falling People practicing an APA program for 3 months Persons who have given their consent to participate in the study

Exclusion Criteria:

* Patient refusal to participate in the study Absolute or relative contraindication to APA Persons under guardianship Non-affiliation to a social security scheme

Primary outcomes:
measure: SPPB Short Physical Performance Battery
timeFrame: Twice throughout study at baseline and 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06896019: The Association Mechanism Between the Microbiome and the Development of Community Pneumonia Was Studied Based on the Analysis of Pulmonary Microbiota - Host Interaction Network
Official title: The Association Mechanism Between the Microbiome and the Development of Community Pneumonia Was Studied Based on the Analysis of Pulmonary Microbiota - Host Interaction Network
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Community Pneumonia
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with community-acquired pneumonia

Brief summary: 1. The difference of lung flora between the healthy group and the CAP group was compared, and the core flora involved in the development of CAP was identified.
2. To predict the metabolites associated with CAP.
3. Identification of genes related to immune response in CAP.
4. Construct the pulmonary microbiota - host interaction network with metabolites as the link.


Eligibility criteria: Inclusion Criteria:

* According to the CAP clinical diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China (2016 edition), cases eligible for community-acquired pneumonia were included and screened.

Exclusion Criteria:

* Alveolar lavage fluid samples without electronic bronchoscopy were excluded for mNGS etiological examination of the case.

Primary outcomes:
measure: Community Pneumonia
timeFrame: 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sent Memorial Hospital
state: Guangdong
Study officials:
References: