louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06305364: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Official title: Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Gastrointestinal Microbiome
Keywords: Artificial Intelligence
Lead sponsor: Jubaan Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.


Eligibility criteria: Inclusion Criteria:

1. Males or females
2. Age: 18-75 years, inclusive
3. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:

   1. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
   2. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).
4. Able to comprehend and provide informed consent.

Exclusion Criteria:

1. Subject who is not a suitable candidate for a colonoscopy
2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
4. Patients with a disability to extend their tongue.
5. Patients with tongue piercings.

Primary outcomes:
measure: Primary Safety Endpoint - Number of device related adverse events and serious adverse events
timeFrame: 1 day
measure: Primary Efficacy Endpoint - Gixam's diagnostic accuracy
timeFrame: 14 days (till pathology report is received)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Westside GI
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian / Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Jubaan Ltd.
name: Daniella Bleistein
role: STUDY_DIRECTOR
References:
Clinical trial NCT01731964: Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Official title: Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Age Related Macular Degeneration
Keywords: Macular Degeneration
Visual Impairment
Implantable Telescope
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Detailed description: Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Baseline measurements will include successful use of an external telescope.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Eligibility criteria: Inclusion Criteria:

Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvment. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator.

Exclusion Criteria:

Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any introcular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Primary outcomes:
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Isaac Avni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05106764: Early Detection of Fabry Disease
Official title: Early Detection of Fabry Disease (FD): Using Real-World Data for the Development of Advanced Natural Language Processing Methods: Retrospective Database Analysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fabry Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from all in-patient or out- patient datasets of the participating hospital in the last 10 years will be used to test the forecasting power of the algorithm.

Brief summary: The main aim of this study is early detection of FD using real-world data for the development of advanced natural language processing methods and to develop a predictive algorithm and to measure the performance of the algorithm in identifying participants with FD.

This study is about using data from hospital Electronic Health Record database from the last 10 years to describe the ranking of participants with FD using multilevel likelihood ratios and to validate the algorithm using positive controls. No investigational medicinal product or device will be tested in this study. Hospital electronic health record data will be analyzed for a period of up to 6 months.


Eligibility criteria: Inclusion criteria:

* In-patient or out-patient datasets of the participating hospital in the last 10 years
* Participants at any age Positive controls: a subset of all participant hospital records that includes the participants with confirmed FD.

Primary outcomes:
measure: Percentage of Participants With Positive Predictive Value (PPV) at Different Cut-off Values (top 10, 20, 50, 100 and 200)
timeFrame: Up to End of the study (approximately 6 months)
Secondary outcomes:
measure: Percentage of Participants Based on Ranking With Known FD Using Multilevel Likelihood Ratios For Algorithm Validation Purposes
timeFrame: Up to End of the study (approximately 6 months)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Kinder- und Jugendklinik
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Neurologische Klinik
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz Villa Metabolica Zentrum für Kinder- und Jugendmedizin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03746964: Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients with Ascending Aortic Aneurysm
Official title: Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients with Ascending Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient with Ascending Aortic Aneurysm with Surgical Indication for Replacement
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 200
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: Patient in preoperative consultation in the cardiovascular and thoracic surgery department.

Brief summary: The biomechanical properties of the aorta are currently poorly understood. A better understanding would optimize surgical indications and monitoring techniques for patients with thoracic aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

* Person who has given oral consent
* Patient with ascending aortic aneurysm with surgical indication for replacement
* Age \> 18 years old
* Scheduled surgery

Exclusion Criteria:

* Person not affiliated to the national health insurance system
* Protected adult
* Pregnant or breastfeeding woman
* MRI Contraindication
* Emergency surgical procedure

Primary outcomes:
measure: aortic compliance by cardiac MRI
timeFrame: Before surgery
measure: In-vitro testing of the elasticity of the aortic wall fragment collected during surgery.
timeFrame: through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT02604264: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Official title: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Pursuit Vascular, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fresenius Medical Care North America
First posted: 2015-11-13
Enrollment: 2912
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: To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.


Eligibility criteria: Inclusion Criteria:

* All patients dialyzing with a central venous catheter

Exclusion Criteria:

* Known allergy to chlorhexidine

Primary outcomes:
measure: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Frenova Renal Research
state: Massachusetts
Study officials:
affiliation: Fresenius Medical Care North America
name: Jeffrey Hymes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hymes JL, Mooney A, Van Zandt C, Lynch L, Ziebol R, Killion D. Dialysis Catheter-Related Bloodstream Infections: A Cluster-Randomized Trial of the ClearGuard HD Antimicrobial Barrier Cap. Am J Kidney Dis. 2017 Feb;69(2):220-227. doi: 10.1053/j.ajkd.2016.09.014. Epub 2016 Nov 10.
citation: Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
Clinical trial NCT04511364: CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
Official title: Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporosis
Keywords: local osteo-enhancement procedure
hip fracture/prevention and control
calcium phosphate
calcium sulphate
LOEP
CONFIRM Extension
Lead sponsor: AgNovos Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.

To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).

Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.


Eligibility criteria: Inclusion Criteria:

* Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
* Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
* Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

* Subject was withdrawn from CONFIRM.
* Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.

Primary outcomes:
measure: Change in DXA score at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Change in DXA score at 60 months
timeFrame: 60 months
measure: Hip fracture incidence
timeFrame: 60 months
measure: Radiologic bone formation
timeFrame: 60 months
Other outcomes:
measure: Safety evaluation
timeFrame: 60 months
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: AZ Nikolaas
name: Jo De Schepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pajor A, Grof J, Idei M, Menyhart J, Zsolnai B. Utero-inhibin: a new substance inhibiting uterine contraction, isolated from amniotic fluid. Acta Physiol Acad Sci Hung. 1982;59(4):325-8.
citation: Harsoulis P, Ekonomou A, Leontsini M, Efthimiou E, Gerasimidis T, Vlotidis J, Sbarounis C. Fine needle aspiration biopsy cytology in the diagnosis of thyroid cancer. Acta Endocrinol Suppl (Copenh). 1984;265:50-1. doi: 10.1530/acta.0.107s0050. No abstract available.
Clinical trial NCT02158364: Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Specified Drug-use Survey of Vaccinees After the Second Vaccination
Official title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Specified Drug-use Survey of Vaccinees After the Second Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measles/Rubella
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 3331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Measles/rubella

Brief summary: The purpose of this survey is to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the second vaccination.

Detailed description: This survey was designed to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence safety after the second vaccination.

Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection \[Japanese Pharmacopoeia\]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.

In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."

Eligibility criteria: Inclusion Criteria:

-

Vaccinees who meet both of the following conditions \[1\] and \[2\]:

1. Vaccinees who have a prior history of receiving measles and/or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine "Takeda" as the second vaccination
2. Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine "Takeda"

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With Serious Adverse Drug Reactions (ADRs)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00673764: The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* Must not have worn contact lenses for 12 hours prior to Day 1

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Time at Best Corrected Visual Acuity
timeFrame: 15 minutes, 45 minutes, and 90 minutes post-dose
Secondary outcomes:
measure: Functional Blink Rate Time (Time Between Blinks)
timeFrame: 15 minutes, 45 minutes, and 90 minutes post-dose
Other outcomes:
Locations:
city: North Andover
country: United States
facility: North Andover
state: Massachusetts
Study officials:
References:
Clinical trial NCT00283764: Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device
Official title: A Phase 3, 12-Week, Parallel-Design Study Comparing The Safety, Efficacy, and Ease Of Use Of Xalatan When Self-Administered By Subjects With Open-Angle Glaucoma Or Ocular Hypertension Using Either A Conventional Dropper Bottle Or A Forced-Flow Delivery Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 0
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: Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes

Exclusion Criteria:

* History of closed/barely open anterior chamber angle or a history of angle closure

Primary outcomes:
measure: Intra-ocular pressure (IOP) level in the study eye.
Secondary outcomes:
measure: Successful eyedrop self-deliveries
measure: Ease of eyedrop administration
measure: Change in safety assessments throughout the study period
measure: Subject preference for the method of drop delivery
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02236364: Noninvasive Blood Glucose Monitoring Method Based on Imaging of the Eye
Official title: Blood Glucose Monitoring Based on Imaging of the Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Toledo
Sponsor class: OTHER
Collaborators: name: University of Toledo
First posted: 2014-09-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator

Exclusion Criteria:

* Patients with any disease or abnormality of the eye
* Patients who are mentally incapacitated, cognitively impaired or with severe psychological disorders and cannot sign consent on their own

Primary outcomes:
measure: Photographic Images of the eye
timeFrame: 60 day period
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
References: