louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06873737: Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker
Official title: Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.

Detailed description: The aim of this study is to analyze the levels of circulating placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia to investigate the potential role of HLA-DR as early biomarker.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women
* Aged \> 18 years

Exclusion Criteria:

* age \< 18 years
* women unable to give informed consent
* infectious diseases
* twin pregnancies

Primary outcomes:
measure: Levels of circulating HLA-DR+ extracellular vesicles
timeFrame: During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Chiara Tersigni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854437: The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphatemia
Keywords: mg oxide
hyperphosphatemia
plasma phosphor level
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hemodialysis patients

Brief summary: Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

hemodialysis with duration\>3 months serum P level \>5.5 mg/dl serum Ca\>8 mg/dl.

Exclusion Criteria:

Mg level \>3 mg/dl

Primary outcomes:
measure: plasma phosphate level
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University Hemodialysis Center
state: Fars
Study officials:
References:
Clinical trial NCT06669637: Amplify EP Registry
Official title: Amplify EP Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Ablation
Radiofrequency
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2024-11-01
Enrollment: 1100
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: Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS

Brief summary: An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation


Eligibility criteria: Inclusion Criteria:

* Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.
* Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.
* De Novo or redo AF catheter ablation procedures.
* Able and willing to participate in baseline and all follow up evaluations.
* 18 years of age or older.

Exclusion Criteria:

* Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.
* In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.

Primary outcomes:
measure: Long term effectiveness
timeFrame: 12-month
Secondary outcomes:
measure: Acute success
timeFrame: at time of procedure
measure: Acute safety
timeFrame: 30 days
measure: Long term safety
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00797537: Ultrasound and X-ray in Detecting Articular Cartilage Calcification
Official title: Concordance Entre l'échographie du Genou et la Radiographie Standard Dans la détection Des Calcifications Dans le Cadre de la Chondrocalcinose Articulaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chondrocalcinosis
Articular Cartilage Calcification
Keywords: Inflammation of bone and cartilage
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 166
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective study with an echography of the 2 knees and radiography of the 2 knees (front and profile) for each patient. If found calcification on ultrasound further examination with ultrasound wrists, hips and shoulders.

Detailed description: Osteo-articular echography is currently recognized as an important development among rheumatologists.

Chondrocalcinosis, which can promote joint inflammation and cartilage degeneration, is highly prevalent in elderly subjects.

Osteo-articular echography is currently reconized as an important development among rheumatologists and can efficiently use to detect Chondrocalcinosis.

The aim of this study is to find a correlation between radiography and echography in detecting CPPD crystal deposition, on a sample of patients and more important with a new generation of ultrasound with a probe superficial performance.

166 patients will be enrolled in this trial and an echography and a radiography of the 2 knees (front and profile) will be done for each patient.

Ih the echography show a calcification, further exams with wrists, hips shoulders echographies will be conducted.

In case of liquid epanchement, analysis of the liquid will be carried in order to eliminate the differential diagnostic including septic arthritis

Eligibility criteria: Inclusion Criteria:

* patient\> 70 years
* articular pathology of the knee
* consent signed

Exclusion Criteria:

* Not covered by social security

Primary outcomes:
measure: Knee calcification detected by echography and radiography
timeFrame: Day 1
Secondary outcomes:
measure: Calcification description and other localisations finding
timeFrame: Day 1
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Rhumatologie
Study officials:
References:
Clinical trial NCT02200237: A Clinical Study for Inactivated Vaccine Against EV71
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Enterovirus 71 Human
Keywords: EV71 Vaccine
Lead sponsor: Medigen Vaccine Biologics Corp.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 366
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to \<12yrs.


Eligibility criteria: Main Inclusion Criteria:

1. Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
2. The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

1. Subject with previous known exposure to EV71.
2. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
4. Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Primary outcomes:
measure: To evaluate overall safety of EV71 vaccine in children, throughout the study period
timeFrame: 2 years after study initiation
Secondary outcomes:
measure: To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
timeFrame: 2 years from study initiation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang-Guang Memorial Hospital Lin-Kou
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hosptial
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Min Huang, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810532: NPO Before Sedation
Official title: Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.

Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).


Eligibility criteria: Inclusion Criteria:

* Children scheduled for elective echocardiography
* Aged under 3 years old

Exclusion Criteria:

* Comorbidity other than hear disease or chromosomal disease
* Patients with delayed gastric emptying
* Patients with structural abnormalities of the stomach or esophagus
* Difficult airway management
* Parents refuse to participate in the study
* Unable to achieve sedation
* Neonatal

Primary outcomes:
measure: Gastric astral cross-sectional area
timeFrame: 10 minutes before sedation
Secondary outcomes:
measure: Estimated gastric volume
timeFrame: 10 minutes before sedation
measure: Perlas grade
timeFrame: 10 minutes before sedation
measure: Quality of sdeation
timeFrame: 10 minutes after sedation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT00130832: Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Official title: Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Infections
Gastroenteritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-16
Enrollment: 735
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.


Eligibility criteria: Inclusion Criteria:

* Infants in good health

Exclusion Criteria:

* Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
* Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
* Any condition resulting in depressed immunity
* Any allergy to any vaccine component as stated in the package circulars
* Allergies to polymyxin B, neomycin or any other antibiotics
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment
* History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
* History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
* Prior receipt of a blood transfusion or blood products, including immunoglobulin
* Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
* Infants residing in a household with an immunocompromised person

Primary outcomes:
measure: Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3
timeFrame: Approximately 42 days Postdose 3
measure: GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
timeFrame: Approximately 42 days Postdose 3
measure: Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered
timeFrame: Approximately 42 days Postdose 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.
Clinical trial NCT05486832: Safety and Performance of the Cardiovalve TR Replacement System
Official title: Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid valve
Heart valve
Cardiovascular disease
Lead sponsor: Cardiovalve Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm, open label, multi center
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Detailed description: The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System

Eligibility criteria: Inclusion Criteria:

* Functional TR ≥3+
* Symptomatic, NYHA Class II-IVa
* Patient approved by the Subject Screening Committee

Exclusion Criteria:

* Cardiac anatomy deemed not suitable for the Cardiovalve TR system
* Hemodynamic instability
* Severe right ventricular failure
* Refractory heart failure requiring advanced intervention

Primary outcomes:
measure: Freedom from device or procedure-related adverse events
timeFrame: 30 days
measure: Reduction in TR grade
timeFrame: 30 days
Secondary outcomes:
measure: Six minute walk test
timeFrame: 30 days, 6 months, 12 months, annual for five years
measure: KCCQ
timeFrame: 30 days, 6 months, 12 months, annual for five years
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Universität Bochum
city: Berlin
country: Germany
facility: Charité university
city: Bonn
country: Germany
facility: Uniklinik Bonn
city: Hamburg
country: Germany
facility: Universitäres Herz
city: Köln
country: Germany
facility: Herzzentrum Uniklinik
city: Lübeck
country: Germany
facility: University Heart Center Lübeck
city: Regensburg
country: Germany
facility: Universitätsklinikum - Regensburg
Study officials:
References:
Clinical trial NCT00120432: Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Official title: Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eye Diseases
Keywords: single dose
mydriatic drug
pupillary dilation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2005-07-18
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
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

Detailed description: To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.

Eligibility criteria: Inclusion Criteria:

* aged between 20 and 80 years old
* dark iris
* require binocular indirect ophthalmoscopy for complete ocular examination
* signed written consent forms

Exclusion Criteria:

* history of ocular trauma
* history of intraocular surgery
* history of laser treatment
* previous eye drop instillation that may affect pupillary dilation
* ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis
* history of diabetes mellitus, severe hypertension and cardiovascular diseases

Primary outcomes:
measure: horizontal pupil diameter
timeFrame: 30 min
Secondary outcomes:
measure: systolic blood pressure
timeFrame: 30 min
measure: diastolic blood pressure
timeFrame: 30 min
measure: heart rate
timeFrame: 30 min
measure: adverse drug reaction
timeFrame: 30 min
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University
name: Yosanan Yospaiboon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.
Clinical trial NCT03778437: Facilitating Needle Alignment With Aiming Method
Official title: Aiming Method May Facilitate Needle Alignment in Ultrasound-guided Subclavian Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheters
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 474
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: PREVENTION

Brief summary: Although ultrasound-guided catheterization of the subclavian vein is becoming standard procedure in anesthetic practice, failure to align the needle and the transducer still can lead to possibly complications. In this study, we proposed a new alignment method, namely Aiming Method. The purpose of this study is to investigate whether the use of this aiming method improved resident volunteers' performance of ultrasound-guided SC insertion in real patients. Specifically, residents were asked to perform three different methods: landmark techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide techniques.


Eligibility criteria: Inclusion Criteria:

* 18 years to 70 years
* American Society of Anesthesiologists (ASA) Physical Status Ⅰ-Ⅲ
* Elective surgery patients requiring subclavian vein catheterization

Exclusion Criteria:

* Local anatomic abnormalities in subclavicular area
* Preexisting subclavian vein thrombosis or coagulation disorders
* Refusal of subclavian vein catheterization

Primary outcomes:
measure: Procedural time
timeFrame: 24 hours
measure: Number of skin breaks
timeFrame: 24 hours
Secondary outcomes:
measure: The incidence of arterial puncture
timeFrame: 24 hours
measure: The incidence of pneumothorax
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital
Study officials:
References: