louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05037357: Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements
Official title: Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements at Multiple Centers in NPC Epidemic Regions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
plasma EBV DNA
Harmonization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wuzhou Red Cross Hospital
name: Zhongshan People's Hospital, Guangdong, China
First posted: 2021-09-08
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NPC patients or Plasma EBV DNA positive people

Brief summary: Plasma Epstein-Barr virus (EBV) DNA will be measured in native plasma samples of nasopharyngeal carcinoma (NPC) patients, respectively, by three medical centers and a qualified laboratory in Southern China, the highest endemic area of NPC. Passing-Bablok regression and difference plots will be used to compare results from each center to the all-method median and mean values. Agreement among methods will be evaluated against bias derived from a biological variation.

Detailed description: The investigators intend to collect EBV DNA positive plasma samples of NPC patients, distribute the samples to four test centers and compare the measurement results to obtain the current status of the agreement of plasma EBV DNA measuring at different centers with various measurement systems in the endemic regions of NPC. A series of statistical analyses including Cohen's Kappa, intraclass correlation coefficient, and Passing-Bablok regression will be adopted for the consistency test. A harmonization study by using the same calibrators will be conducted.

Eligibility criteria: Inclusion Criteria:

* Age between 18-70 years
* Histologically confirmed NPC or Non-NPC with positive plasma cell-free EBV DNA

Exclusion Criteria:

* unsatisfactory performance status: Karnofsky scale (KPS) \<= 70
* Any severe intercurrent disease
* Any contraindication of blood sampling

Primary outcomes:
measure: Plasma EBV DNA
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06007157: Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes
Official title: Effects of Sodium Glucose Cotransporter-2 Inhibitors on Salt-sensitivity in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Salt; Excess
Diabete Type 2
Keywords: Salt sensitivity
Sodium glucose cotransporter 2 inhibitors
Type 2 Diabetes
Blood Pressure
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: European Foundation for the Study of Diabetes
First posted: 2023-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.

Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:

* 24-h ambulatory blood pressure measurement;
* 24-h urine collection;
* bioimpedance analysis for body composition determination;
* blood and urine tests.

The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years;
* both males and females;
* type 2 diabetes.

Exclusion Criteria:

* type 1 diabetes;
* insulin treatment;
* uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \>95 mmHg);
* pregnancy;
* other acute or chronic conditions influencing blood pressure and glucose metabolism.

Primary outcomes:
measure: 24-hour Blood Pressure
timeFrame: 2 weeks
Secondary outcomes:
measure: Sodium excretion
timeFrame: 2 weeks
measure: Hydration state
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Andrea Natali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753557: Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Official title: A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C (CHC)
Keywords: Pegasys
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.


Eligibility criteria: Inclusion Criteria:

* Genotype 1 CHC
* treatment-naïve or relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia, or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: 48 weeks
Secondary outcomes:
measure: Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
timeFrame: 4 weeks
measure: Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
timeFrame: 24 weeks
measure: Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
timeFrame: 36 weeks
measure: Transition of Serum HCV RNA Levels
timeFrame: baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
measure: Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
timeFrame: From baseline to 24 weeks after completion of drug administration
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, M.D.
role: STUDY_DIRECTOR
References:
citation: Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.
Clinical trial NCT04126057: Myopia Assessment of Two Manufacturing Processes
Official title: Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Myopia
Keywords: Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 and 14 years old (inclusive) with myopia
* Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye
* Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D

Exclusion Criteria:

* Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.)
* Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)

Primary outcomes:
measure: Change in Axial Length Progression From Baseline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare PC
state: Missouri
city: New York
country: United States
facility: SUNY School of Optometry
state: New York
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
Study officials:
affiliation: SightGlass Vision, Inc.
name: Joseph Rappon, OD, MS, FAAO
role: STUDY_CHAIR
References:
Clinical trial NCT02577757: Establishing the Language Network With Independent Component Analysis of Resting State MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Languages
Keywords: Languages network
Functional MRI
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Detailed description: Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Eligibility criteria: Inclusion Criteria:

* Persons major and minor.
* Having given their written consent, or whose parents have given their written consent for minors.
* Affiliated with the social security system
* All patients eligible adults in awake surgery
* Affiliated with the social security system
* patient given their written consent

Exclusion Criteria

* Contraindications to MRI
* Pregnant or breastfeeding women

Primary outcomes:
measure: MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: UH ANGERS
name: ARAM TER MINASSIAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433157: Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
Official title: Clinical and Radiological Evaluation of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Teeth
Dental Caries
Dentin, Carious
Keywords: stainless stain crowns
Hall technique
children
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique

Detailed description: Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.

Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Eligibility criteria: Inclusion Criteria:

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients who have two first and/or second primary molars with caries affecting at least two surfaces
* Patients who are cooperative for the dental procedure

Exclusion Criteria:

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients with a systemic disease,
* Patients who have orthodontic treatment
* Teeth which have a short period of time for succedaneous teeth to erupt
* Teeth which need vital or non-vital endodontic treatment
* Patients and/or parents who does not accept the esthetic appearance of SSC

Primary outcomes:
measure: Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zafer C Cehreli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.
Clinical trial NCT02874157: Evaluation of Methods for Diagnosis of Cytomegalovirus Pneumonia in Mechanically Ventilated Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CMV Reactivation Diagnosis in ICU Patient
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 450
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: ICU patient undergoing invasive ventilation for more than 48h

Brief summary: Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL


Eligibility criteria: Inclusion Criteria:

* Patient in ICU with ventilator-associated pneumonia suspicion

Exclusion Criteria:

* ICU pateint undergoing invasive ventilation for less than 48 hour

Primary outcomes:
measure: Number of CMV positive reactivation in ICU patient for sensitivity of quantitative PCR ( qPCR ) on LBA and CMV in whole blood compared with pp65 antigenemia.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Laurent PAPAZIAN, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05173857: Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access
Official title: Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Kidney Diseases
Keywords: Haemodialysis
Fistula
Stenosis
Paclitaxel
Drug-eluting balloon
Angioplasty
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 42
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: Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes.

Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.


Eligibility criteria: Inclusion Criteria:

* Active dialysis with a mature upper extremity dysfunctional haemodialysis access
* Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
* Adult (\>18 years)
* Target vessel diameter 3-8mm

Exclusion Criteria:

* Thrombosed access
* In stent restenosis
* Pregnancy
* Age less than 18 years

Primary outcomes:
measure: Freedom from restenosis in treated vascular access
timeFrame: 12 months
measure: Stenosis or occlusion in treated vascular access
timeFrame: 12 months
measure: Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: