louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06023888: Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation
Official title: A Prospective Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms With OctaRay in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: persistent atrial fibrillation
ablation
driver
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed to determine the efficacy of substrate ablation using waveform periodicity analysis, similarity analysis with OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification., plus phase mapping in persistent AF patients who required substrate modification.
Primary purpose: TREATMENT

Brief summary: STUDY DESIGN A prospective study.

OBJECTIVE A single center clinical trial on the analysis of intracardiac atrial electrogram waveform periodicity for catheter ablation of persistent atrial fibrillation with OCTARAY™ Mapping Catheter, as prospective randomized controlled study.

HYPOTHESIS:

The critical atrial substrates in maintaining persistent atrial fibrillation could be identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic mapping. Based on the previous study, atrial substrate with high-similarity electrogram regions correlated with procedural AF termination and better long-term AF-free (1). Therefore, we proposed that the degree of waveform similarity plus the beat-to-beat sequential morphology (2) (duration of how many similar waveforms can maintain in sequence) would be even better to characterize the atrial substrate and could be potentially critical atrial substrate in prediction of sources of AF. As additional substrate mapping provided benefits compared to PVI alone in patients with persistent AF, we hypothesize that waveform periodicity adjuvant to electrogram similarity and phase mapping could be used to guide radiofrequency ablation in real time. The used of the OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification.


Eligibility criteria: Inclusion Criteria:

* persistent atrial fibrillation
* refractory or intolerant to medication

Exclusion Criteria:

* Previous AF ablation
* LA thrombus
* Previous MAZE procedure
* Poor renal function
* Can't follow-up for one year

Primary outcomes:
measure: Recurrence of atrial arrhythmia
timeFrame: up to 6 month
measure: Recurrence of atrial arrhythmia
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT05048888: Symphony IL-6 Reference Range Study
Official title: Symphony IL-6 Reference Range Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Bluejay Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll approximately 120 apparently healthy individuals, split approximately between males and females, and covering an age range from approximately 18 to 85 years of age at the University of Texas Southwestern Medical Center, or from satellite facilities associated with the medical center. Subjects must meet all eligibility criteria to be in enrolled in the study. Whole blood specimens will be prospectively collected and tested using the Symphony IL-6 system.

Brief summary: Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device.

The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to provide informed consent
* \> 18 years of age
* Whole blood specimen collected in EDTA anticoagulant tubes
* Minimum volume of 100µL for Symphony IL-6 testing
* Specimen is available for testing within 12 hours from collection
* C-Reactive Protein (CRP) \< 10 mg/L

Exclusion Criteria:

* Subjects presenting with a fever
* Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
* Subjects otherwise self-reported as unhealthy
* Hemolyzed specimens

Primary outcomes:
measure: IL-6 Reference Range Study
timeFrame: Specimen is tested within 12 hours from collection
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT02368288: Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
Official title: Efficacies of Entecavir Add on Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 6 Months Treatment of Peginterferon Alpha 2a
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitic B
peginterferon
HBsAg
entecavir
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

Detailed description: HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will be enrolled randomized into two groups, in intervention group, patients will receive entecavir combine with peginterferon alpha 2a(PEG-IFN a-2a) treatment for 48 weeks and follow 24 weeks. Patients in control group will be continue treated with PEG-IFN a-2a for 48 weeks and followed 24 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of the combined therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

Eligibility criteria: Inclusion Criteria:

* HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon a-2a treatment

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: rate of HBeAg seroconversion
timeFrame: 48 weeks
Secondary outcomes:
measure: rate of HBsAg loss
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06783088: Quantification With Lutetium-177 on Cadmium-Zinc-Telluride Camera 3D
Official title: Quantification With Lutetium-177 on Cadmium-Zinc-Telluride Camera 3D
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have already benefited from at least one course of lutetium vipivotide tetraxetan and a recording on a 3D Cadmium Zinc Telluride camera made the day after treatment (image on Day N°1, Day 0 being the day of treatment administration)

Brief summary: The main of this study is to demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 keV (kiloelectronVolts) or 208 keV or a combination of the 2 energy peaks). A study on phantom will optimise the reconstruction parameters. These parameters will then be applied to a population of patients who have already benefited from a recording on a 3D CZT camera (retrospective data).

Detailed description: Lutetium 177 is a beta emitter - and is used in therapy. It also emits during its radioactive decay, two gamma photons of energy 113 and 208 keV allowing to produce images. The dosimetry committee of the European Association for Nuclear Medicine (EANM) recommends using only the peak at 208 keV to obtain so-called quantitative images using a conventional camera also called an Anger camera.

For several years, new semiconductor cameras (CZT cameras) have been available in nuclear medicine departments. They offer better performances particularly in terms of detection sensitivity and energy resolution. The nuclear medicine team has already carried out studies with Lutetium-177 with these semiconductor cameras on phantoms as well as dosimetry studies after treatment using Lutetium-177.

This study should demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 keV or 208 keV or a combination of the 2 energy peaks). A study on phantom will optimise the reconstruction parameters. These parameters will then be applied to a population of patients who have already benefited from a recording on a 3D CZT camera (Retrospective data).

Eligibility criteria: It is a retrospective study and the criteria to collect the imaging are:

Inclusion Criteria:

Patients treated by at least one cure of lutetium vipivotide tetraxetan with imaging

Exclusion Criteria:

Patient having sent an objection to the use of their data

Primary outcomes:
measure: Demonstrate that the quantification of images obtained with the 113 keV peak is equivalent to the quantification obtained with the 208 keV peak.
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02350088: Fast-track Surgery in the Treatment of Hirschsprung's Disease
Official title: Fast-track Surgery in the Treatment of Hirschsprung's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: fast-track surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2015-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Hirschsprung's disease

Detailed description: The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

Eligibility criteria: Inclusion Criteria:

1. surgical treatment for Hirschsprung's disease
2. The first procedure for Hirschsprung's disease
3. Age\<14 years

Exclusion Criteria:

1. conservative treatment for Hirschsprung's disease
2. The reoperation for Hirschsprung's disease
3. Age\>14 years

Primary outcomes:
measure: number of participants with recovery of boewl movements
timeFrame: one year
Secondary outcomes:
measure: Duration of the hospital stay
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhi Li, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01746888: Expanding Antimicrobial Stewardship
Official title: Expanding Antimicrobial Stewardship
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 437
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 65 years of age and older who present to the Emergency Department.

Brief summary: Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.


Eligibility criteria: Inclusion Criteria:

* 65 years of age

Exclusion Criteria:

* Patient incarcerated
* Chief complaint of suicidal or homicidal ideation
* Patient primarily evaluated by the trauma team

Primary outcomes:
measure: Presence of infection while in the Emergency Department
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Wexner Medical Center at The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey M Caterino, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806388: Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project
Official title: Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 5500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Any advanced cancer patient who would benefit from molecular profiling and is a potential clinical trial candidate as identified by treating physician.

Brief summary: This study aims to screen tumor molecular profile for better selection of anticancer treatment, in particular, allocation to clinical trials if available.

Detailed description: Molecular profiling will be performed on archival tumor tissue or freshly collected tumor tissue from re-biopsy. Blood, pleural fluid, FNA, and/or saliva may be collected to study the genetic makeup and also to compare the tumor molecular profile. Personalized therapy will be given based on molecular profile.

Eligibility criteria: Inclusion Criteria:

* Confirmed histological diagnosis of solid tumor
* Suitable for systematic treatment and clinical trials
* ECOG (Eastern cooperative oncology group) performance status \< 2
* Able to provide tumor tissue for molecular profiling
* Able to understand and sign the informed consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: The molecular and clinical epidemiology for cancer patients being considered for novel therapeutics
timeFrame: 5 years
Secondary outcomes:
measure: The proportion of patients who have actionable alterations and enrol into clinical trials
timeFrame: 5 years
measure: The correlation of molecular profiles with clinical outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Daniel SW Tan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chia S, Low JL, Zhang X, Kwang XL, Chong FT, Sharma A, Bertrand D, Toh SY, Leong HS, Thangavelu MT, Hwang JSG, Lim KH, Skanthakumar T, Tan HK, Su Y, Hui Choo S, Hentze H, Tan IBH, Lezhava A, Tan P, Tan DSW, Periyasamy G, Koh JLY, Gopalakrishna Iyer N, DasGupta R. Phenotype-driven precision oncology as a guide for clinical decisions one patient at a time. Nat Commun. 2017 Sep 5;8(1):435. doi: 10.1038/s41467-017-00451-5.
Clinical trial NCT04446988: Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Official title: Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacro-Iliac Spondylosis
Keywords: Sacroiliac
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
Primary purpose: TREATMENT

Brief summary: Sacroiliac joint injection in sacroiliitis

Detailed description: Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sacroiliitis.
* At least 3 positive physical examination maneuvers \[FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test\],
* Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
* Age from 18ys to 60ys.

Exclusion Criteria:

* Ages less than 18 or more than 85 years.
* Body Mass Index (BMI) above 35 kg/m2.
* A diagnosis of severe anxiety or depression and other psychological disorders.
* Allergy to local anesthetics or steroids and pregnancy.
* Multiple comorbidities (renal , hepatic, cardiac).
* Coagulation disorder as bleeding tendency and platelet dysfunction.
* Contraindication for prone position or radiological exposure.
* Patient refuse .
* Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).

Primary outcomes:
measure: Numeric Rating Scale (NRS) pain scores
timeFrame: 3 months
measure: Oswestry disability index score
timeFrame: 1 month
Secondary outcomes:
measure: Analgesic requirement
timeFrame: 1 month
measure: Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
timeFrame: 3 months
measure: Procedure time
timeFrame: Procedure
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: ASSIUT University Hospitals
Study officials:
affiliation: Minia University
name: Hany Ka Mickhael, Ass. pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.
Clinical trial NCT04160988: A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
Official title: A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Acer Being Health Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
First posted: 2019-11-13
Enrollment: 703
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

Brief summary: This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.


Eligibility criteria: Inclusion Criteria:

* Subjects enrolled in this study should meet all the following criteria.

  1. Subject with age ≥ 20 years old
  2. Subject with documented diagnosis of diabetes mellitus
  3. Subject with image taken by color fundus photography that meet the following requirement:

     * The resolution of image is 1024×1024 pixels or higher;
     * The angle view of image is 45 or 50 degree.
  4. Subject's image includes macula and optic nerve as judged by the ophthalmologist.

Exclusion Criteria:

* Subjects will be excluded if they meet any of the following criteria.

  1. The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
  2. The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.

Primary outcomes:
measure: Sensitivity
timeFrame: 2 months
measure: Specificity
timeFrame: 2 months
Secondary outcomes:
measure: Positive Predictive Values (PPV)
timeFrame: 2 months
measure: Negative Predictive Values (NPV)
timeFrame: 2 months
measure: Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR
timeFrame: 2 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: