louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06353659: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU
Official title: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intensive Care Unit
Acute Kidney Injury
Ultrasound
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 60
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: Through literature review, the latest meta-analysis results showed that the area under the curve of CEUS parameters for diagnosing AKI was 0.84 and the width of the confidence interval was 0.22. When α=0.05, the sample size N=54 was obtained by PASS software. Considering the 10% shedding rate, 60 patients were expected to be enrolled in this study.

Brief summary: The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury.

Detailed description: The main questions it aims to answer are:

1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation。
2. To explore the relationship between renal microcirculation and systemic hemodynamics。
3. To explore the value of quantitative evaluation of renal microcirculation changes by contrast-enhanced ultrasound in the diagnosis of acute kidney injury

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* First admission to ICU \< 24h after admission and expected ICU stay ≥48 hours
* Acute kidney injury risk factors (KDIGO 2012)
* Contrast-enhanced ultrasound

Exclusion Criteria:

* Known severe chronic kidney disease (CKD≥ stage 4) or undergoing hemodialysis treatment
* Kidney transplantation or renal malignancy
* Terminal stage of malignant tumor
* Pregnancy
* Renal artery stenosis or renal vein thrombosis
* The quality of CEUS images is poor, and quantitative analysis cannot be performed

Primary outcomes:
measure: Acute kidney injury (according to KDIGO 2012 criteria)
timeFrame: Through study completion, an average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasound, Peking University Third Hospital
name: Ligang Cui, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00393159: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Official title: The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Otitis Media
Conductive Hearing Loss
Keywords: Effusion
Otitis
Media
Ear
Popper
Children
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.


Eligibility criteria: Inclusion Criteria:

* Serous Otitis Media for More Then 3 months
* Conductive Hearing Loss of More Then 15 decibels.
* Tympanometry type B or C.

Exclusion Criteria:

* No History of Tympanostomy Tube Insertion or Adenoidectomy
* No Cranio or Facial Malformations
* No Acute Upper Respiratory Tract Infection or Acute Otitis Media

Primary outcomes:
measure: Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
measure: Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
Secondary outcomes:
measure: Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
measure: Rate of referrals for tympanostomy tube insertion at 3 months
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Yael Oestreicher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02820259: Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
Official title: Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Concentration of Tacrolimus
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: liver-transplanted patients who receive tacrolimus

Brief summary: The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years) of both sexes,
* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
* Not having expressed their opposition to participation in the study

Exclusion Criteria:

* Bilio-enteric anastomosis,
* Associated transplantation of another organ
* Contraindications to TCR administration
* Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.

Primary outcomes:
measure: coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC
timeFrame: during the first 7 days after its initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier universitaire de Rennes
Study officials:
References:
citation: Rayar M, Tron C, Locher C, Chebaro A, Beaurepaire JM, Blondeau M, Cusumano C, Bardou-Jacquet E, Houssel-Debry P, Camus C, Petitcollin A, Verdier MC, Lakehal M, Desfourneaux V, Sulpice L, Meunier B, Bellissant E, Boudjema K, Lemaitre F. Tacrolimus Concentrations Measured in Excreted Bile in Liver Transplant Recipients: The STABILE Study. Clin Ther. 2018 Dec;40(12):2088-2098. doi: 10.1016/j.clinthera.2018.10.015. Epub 2018 Nov 19.
Clinical trial NCT00569959: Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
Official title: Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Normal Glucose Metabolism
Hyperlipidemia
Keywords: fasting lipid measures
non-fasting lipid measures
clinical decision-making
LDL-Cholesterol
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2007-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will examine whether fasting and non-fasting lipid measures can provide similar clinical information in order to guide lipid management by primary physicians. It will compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.


Eligibility criteria: Inclusion Criteria:

* Park Nicollet Health Services patients due for routine lipid measures

Exclusion Criteria:

* Unwilling or unable to provide consent

Primary outcomes:
measure: LDL-Cholesterol
timeFrame: Fasting 12+ hours vs. Non-fasting
Secondary outcomes:
measure: Other lipid parameters
timeFrame: Fasting 12+ hours vs. non-fasting
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Park Nicollet Internal and Family Medicine Clinics
state: Minnesota
Study officials:
affiliation: Park Nicollet Health Services
name: William Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06603259: The Galleri® Community Research Program
Official title: The Galleri® Community Research Program
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Data Collection
Keywords: observational
Galleri test
Multi-cancer early detection
data collection
Lead sponsor: GRAIL, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: up to 250 participants who have received test results following the Galleri test in the real world setting.

Brief summary: GRAIL, the company that developed the Galleri test and is sponsoring this study, would like to learn more from individuals who have received the Galleri multi-cancer early detection test.

The purpose of this study is to understand how health information can be accurately collected from the medical records of individuals who have received the Galleri test in a real world setting. The collected information may include relevant medical and cancer history, diagnostic test results, including the Galleri test result. This will help GRAIL build a future larger study for individuals who have taken the Galleri test. This future study is important for understanding patient journeys after a Galleri test (including any diagnostic testing done and any diagnoses made), for improving the Galleri test, and to contribute to other research on cancer screening.


Eligibility criteria: Inclusion Criteria:

* Have received the Galleri test prescribed by a provider per clinical care
* Capable of giving signed and legally effective informed consent. Consent provided by a legally authorized representative is not permitted in this protocol.
* Have signed HIPAA authorization(s)\* form for their medical records to be released and used for this study.

Exclusion Criteria:

* Patients are excluded from the study if the patient is a GRAIL employee or contractor.
* Patients who have received the Galleri test in a GRAIL-sponsored research setting (i.e., clinical trial) are excluded.

Primary outcomes:
measure: Quality of data retrieved from participants who have received the Galleri test
timeFrame: From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
Secondary outcomes:
measure: Data retrieval methods will be described.
timeFrame: From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
measure: Describe the process of recruiting and consenting patients, and the retrieval of records in a narrative summary.
timeFrame: From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: GRAIL
state: California
Study officials:
affiliation: GRAIL, Inc.
name: Mai Tran, MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448859: Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality
Official title: The Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality at Assisted Reproductive Technology Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Disorders
Keywords: infertility
assisted reproductive technology
embryo quality
oocyte denudation
intracytoplasmic sperm injection
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oocytes are derived from patients enrolled in IVF

Brief summary: An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.

Detailed description: This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.

Eligibility criteria: Inclusion Criteria:

* oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection

Exclusion Criteria:

* oocytes from patients \>40 years old
* oocytes from primary infertility \>5 years
* endometriosis
* polycystic ovarian syndrome

Primary outcomes:
measure: Oocyte denudation time
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitas Padjadjaran
name: Dian Tjahyadi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isiklar A, Mercan R, Balaban B, Alatas C, Aksoy S, Urman B. Impact of oocyte pre-incubation time on fertilization, embryo quality and pregnancy rate after intracytoplasmic sperm injection. Reprod Biomed Online. 2004 Jun;8(6):682-6. doi: 10.1016/s1472-6483(10)61649-5.
Clinical trial NCT01749059: The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
Official title: The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 6147
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates known to have a congenital heart defect at the time of screening.

Brief summary: The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.


Eligibility criteria: Inclusion Criteria:

1. Documentation of informed consent and authorization.
2. Full term and late preterm newborns (EGA 35-44 weeks)
3. On room air
4. Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
5. Parents agree to follow-up contact post discharge

Exclusion Criteria:

1. On supplemental oxygen
2. Admitted to the Neonatal Intensive Care Unit
3. Parents do not agree to follow-up
4. Greater than 30 days of age

Primary outcomes:
measure: True Positive Rate
timeFrame: One year follow-up
measure: False Positive Rate
timeFrame: One year follow-up
measure: True Negative Rate
timeFrame: One year follow-up
measure: False Negative Rate
timeFrame: One year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Trenton
country: United States
facility: Capital Health Regional Medical Center - Pediatrix Medical Group
state: New Jersey
Study officials:
affiliation: Pediatrix
name: Reese H Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573959: Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
Official title: Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Disease
Inflammatory Bowel Diseases
Crohn Disease
Ulcer
Celiac Disease
Keywords: Intestinal Disease
Inflammatory Bowel Diseases
Crohn Disease
Ulcer
Celiac Disease
Angioectasia
Polyp
Lead sponsor: Capso Vision, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Generic Devices Consulting, Inc.
First posted: 2020-10-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

Detailed description: The purpose of the study is validate the an updated version of the CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

The system to be validated consists of an updated version of the CapsoCam® SV-3 video capsule endoscope, the CapsoView® CVV Software, the CapsoAccess ® Capsule Data Access System (CDAS3) and the CapsoRetrieve® Capsule Retrieval Kit for the collection of the excreted CapsoCam capsule.

The captured CapsoCam® SV-3 capsule images of the small bowel will be downloaded via the CapsoAccess® Capsule Data Access System (CDAS3) to a computer and proprietary CapsoView® CVV Software is used to review capsule images. The CapsoView® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* Willing and able to provide written informed consent
* Completion of pre-study questionnaire
* Approval of study principal investigator

Exclusion Criteria:

* Subjects with abdominal pain of unknown origin
* Difficulty Swallowing
* Known or suspected gastrointestinal disease
* Diarrhea or constipation
* Anemia of unknown origin
* Rectal or other gastrointestinal bleeding
* Pregnancy

Primary outcomes:
measure: Ability to capture images
timeFrame: 2 weeks
measure: Ability to download images
timeFrame: 2 weeks
measure: Diagnostic Quality of Images
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saratoga
country: United States
facility: CapsoVision, Inc.
state: California
Study officials:
affiliation: CapsoVision Research Center
name: David Shields, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958759: Functional Inspiratory Muscle Training in Chronic Kidney Disease
Official title: The Effects of Functional Inspiratory Muscle Training on Respiratory and Peripheral Muscle Functions in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Respiratory muscle
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease not receiving dialysis
* Access to the online program
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskeletal problem
* Having decompensated diabetes
* Having uncontrolled hypertension

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: 10 minutes
measure: Respiratory muscle endurance
timeFrame: 10 minutes
measure: Pulmonary function
timeFrame: 5 minutes
measure: Peripheral muscle strength
timeFrame: 5 minutes
measure: Endurance of trunk muscles
timeFrame: 10 minutes
measure: Lower extremity muscle endurance
timeFrame: 1 minutes
measure: Functional capacity
timeFrame: 10 minutes
measure: Diaphragm thickness and mobility
timeFrame: 20 minutes
Secondary outcomes:
measure: Balance
timeFrame: 5 minutes
measure: Static balance
timeFrame: 5 minutes
measure: Posture
timeFrame: 5 minutes
measure: Qol
timeFrame: 10 minutes
measure: Cognitive function
timeFrame: 5 minutes
measure: Fatigue
timeFrame: 5 minutes
measure: Physical activity
timeFrame: 5 minutes
measure: Endothelial function
timeFrame: 10 minutes
measure: Aortic stiffness
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Merve Firat, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Tolga Yildirim, MD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Deniz İnal-İnce, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Melda Saglam, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Calik-Kutukcu, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Selin Ardali-Duzgun, MD
role: STUDY_CHAIR
References: