louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04599959: COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
Official title: COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the tests is to establish saliva collection with Salivette® Cortisol.


Eligibility criteria: Inclusion Criteria:

1. Informed consent form signed and dated before any samples have been taken.
2. Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
3. Male and/or female patients aged 18 years and over.

Primary outcomes:
measure: Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
timeFrame: At baseline (the test day), up to one day.
measure: Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany
timeFrame: At baseline (the test day), up to one day.
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Study officials:
References:
Clinical trial NCT04776759: Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
Official title: Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lone Atrial Fibrillation
Keywords: Atrial Fibrillation
Lone Atrial Fibrillation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 200
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients (i.e. \< or = to 35-year-old) at the time of first atrial fibrillation episode.

Brief summary: Atrial fibrillation is a rare cardiac arrhythmia in young (i.e. \<= 35-year-old) patients. Etiological factors, current management and mid- to long-term outcomes remain unknown.

Detailed description: Atrial Fibrillation in YOUNG patients (YOUNG-AF) is a prospective, observational, multicentric registry, including every consecutive patients aged \< 35-year-old with a diagnosis of atrial fibrillation. The registry will assess demographical, physical activity, toxicologic and genetic factors, as well as current management regarding anticoagulation, anti-arrhythmic drugs and catheter ablation. As an observational registry, patient will be managed with the guidelines-directed standard-of-care.

Eligibility criteria: Inclusion Criteria:

* First episode of atrial fibrillation
* Less than 35-year-old
* Diagnostic by 12-lead ECG or continuous monitoring (minimal duration 30 seconds)
* French Social Security number

Exclusion Criteria:

* Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)

Primary outcomes:
measure: Composite of mortality, thromboembolic event and heart failure
timeFrame: at 10-year
measure: Recurrent symptomatic atrial fibrillation.
timeFrame: at 10-year
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
References:
Clinical trial NCT01732159: Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery
Official title: Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgery Programmed
Keywords: Ambulatory surgery
Checklist
Cancellation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 4093
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the impact of a check list on the rate of late cancellation, i.e. the day before or the day of the ambulatory surgery.

Detailed description: The checklist is administered to the patients by phone between 7 and 3 days before the surgery. Each item of the checklist is associated with a decisional algorithm that allows take care for patients in case of any problem.

Eligibility criteria: Inclusion Criteria:

* Patient (adult or minor) for which ambulatory surgery is programmed in a multipurpose ASU
* Surgery under general anesthesia or loco
* Regional or neuroleptanalgesia3. Patient contacted by phone
* Patient does not oppose his participation in the study

Exclusion Criteria:

* Patient programmed for endoscopy in ASU non surgical
* Ambulatory surgery scheduled for orthogenic
* Ambulatory surgery scheduled for urgency
* Ambulatory surgery performed under local anesthesia

Primary outcomes:
measure: Decrease in the rate of late cancellation
timeFrame: At day 0 (the day of the surgery)
Secondary outcomes:
measure: Improvement of the organization of the ambulatory unit
timeFrame: At day 0 (the day of the surgery)
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital
name: Jean-Pierre BETHOUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaucher S, Boutron I, Marchand-Maillet F, Baron G, Douard R, Bethoux JP; AMBUPROG Group Investigators. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial. PLoS One. 2016 Feb 1;11(2):e0147194. doi: 10.1371/journal.pone.0147194. eCollection 2016.
Clinical trial NCT01694459: DEDICA (Dose of HEparin During Coronary Angioplasty) Trial
Official title: Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina
Angina, Unstable
Non-ST Elevation (NSTEMI) Myocardial Infarction
Keywords: angioplasty
heparin
trial
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2012-09-27
Enrollment: 1000
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: International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.

Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.

Detailed description: * Patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with ST-elevation myocardial infarction will be excluded.
* An ACT (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target ACT will be \> 300 sec. (as recommended by guidelines) while for the low-dose the target ACT will be \> 180 sec.

Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.

Eligibility criteria: Inclusion Criteria:

* Stable angina, unstable angina or Non-ST elevation myocardial infarction undergoing coronary angioplasty.
* Mandatory pretreatment with aspirin and clopidogrel

Exclusion Criteria:

* ST elevation myocardial infarction
* Coronary interventions with rotational atherectomy
* Coronary interventions on chronic total occlusions (CTO)

Primary outcomes:
measure: MACE + stent thrombosis + major bleeding (TIMI definition)
timeFrame: 30 days
Secondary outcomes:
measure: MACE
timeFrame: 30 days
measure: Major Bleeding
timeFrame: 30 days
measure: Stent thrombosis
timeFrame: 30 days
measure: CK-MB increase
timeFrame: 30 days
Other outcomes:
measure: Major bleeding
timeFrame: 30 days
Locations:
city: Rome
country: Italy
facility: University of Rome La Sapienza
Study officials:
affiliation: San Filippo Neri Hospital
name: Vincenzo Pasceri, MD
role: STUDY_CHAIR
affiliation: University of Roma La Sapienza
name: Francesco Pelliccia, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00571259: Prophylactic Antimicrobial Catheter Lock
Official title: Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacteremia
Keywords: Sodium citrate
Gentamicin
Prophylaxis
Hemodialysis
Central venous catheter
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

Detailed description: The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.

Eligibility criteria: Inclusion Criteria:

* Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
* Must be at least 18 years old
* Compliant with a dialysis treatment schedule
* Plans to continue hemodialysis treatment and follow-up at the investigational site
* Must be able to care for the exit site independently or have someone who is able to care for the site for them
* Must be able to sign the informed consent document

Exclusion Criteria:

* The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
* Active exit site or tunnel infection
* Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
* Known to have antibodies to heparin
* Allergy to pork heparin
* Allergy to gentamicin
* Subject is pregnant
* Known intravenous drug abuse

Primary outcomes:
measure: Rate of Device-related Bacteremia
timeFrame: 5 years
Secondary outcomes:
measure: Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
timeFrame: 5 years
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Satellite Healthcare, Inc
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Norman Coplon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433259: Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens
Official title: The Influence on Biometric Factors Changes by Different OK Lens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contact Lenses
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects fit with VST or CRT type lens are reviewed 1 day to 2 year after first wearing the lens. Ocular examinations were performed, including slit-lamp biomicroscope, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), corneal topography (Medmont E300W, Medmont Pty Ltd, Melbourne, Australia), corneal refractive power (autorefractometer, KR880, Topcon, JAPAN), corneal epithelial thickness (Optical Coherence Tomography, RTVue-XR), axial length using IOL-Master 700 (Carl Zeiss Meditec AG). To investigate corneal and retina changes caused by overnight OK lens.


Eligibility criteria: Inclusion Criteria:

* Normal subjects without any history of ocular surgeries or diseases (except for refractive errors) or systemic diseases that might affect contact lens wearing. The spherical error between -1.0 and -5.0 D, cylindrical error of at most 2.0 D, and a corrected distance visual acuity of 20/20 or better.

Exclusion Criteria:

* Subjects who had previously worn contact lens, were also excluded

Primary outcomes:
measure: change of Corneal Epithelium
timeFrame: up to 1 day, 1 week,1 month
Secondary outcomes:
measure: Axial length
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT05755659: Clinical on the Safety and Efficacy of Fosaprepitant Dimeglumine for Injection in the Prevention of CINV.
Official title: Clinical on the Safety and Effectiveness of Fosaprepitant Dimeglumine for Injection in the Prevention of Nausea and Vomiting Caused by Tumor Chemotherapy Drugs.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the safety of Fosaprepitant Dimeglumine Injection for the prevention of nausea and vomiting caused by tumor chemotherapy drugs, analyze the characteristics of the applicable population and clinical medication of Fosaprepitant Dimeglumine, evaluate the risk factors that may affect the efficacy of drug use, and compare the clinical benefits of different drug use modes.

Detailed description: This is a prospective, one arm, open, non-interference, multi center, observational, real world clinical study.

Study drug: Fosaprepitant Dimeglumine for injection. White or almost white lump or powder, containing 150mg (calculated as C23H22F7N4O6P). This product is a NK-1 receptor antagonist, which is administered jointly with other antiemetic drugs. It is suitable for adult patients to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetic chemotherapy drugs (HEC).

Eligibility criteria: Inclusion Criteria:

* Patients with nausea and vomiting caused by chemotherapy
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Hypersensitive to any component in this product
* Patients taking pimozide, terfenadine, astemizole and cisapride

Primary outcomes:
measure: Safety of Fosaprepitant Dimeglumine
timeFrame: 7 day
measure: Effectiveness of Fosaprepitant Dimeglumine
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shaanxi
Study officials:
affiliation: Digestive surgery
name: Hong Liu
role: STUDY_CHAIR
References:
Clinical trial NCT02844959: Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation
Official title: Assessment of Course of Inflammatory Biomarkers Concentrations After Pulmonary Veins Isolation as a Prognostic Factor of Atrial Fibrillation Treatment Effectiveness (ACtIVE-AF Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Biomarkers
Inflammatory Response
C-reactive protein
FGF2
MMP8
troponin I
body temperature
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 120
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: Study includes adult patients qualified for ablation due to atrial fibrillation.

Brief summary: The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial fibrillation recurrency after ablation. Inflammatory response will be assessed by double measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix metallopeptidase 8 (MMP8) and body temperature. Dynamics of change of troponin I will be measured additionally.

After ablation each patient will be monitored with ECG telemonitoring system for 7 days.


Eligibility criteria: Inclusion Criteria:

* signed consent;
* criteria for ablation of atrial fibrillation.

Exclusion Criteria:

* previous pulmonary veins isolation;
* ablation other than pulmonary veins isolation during the procedure;
* atrial fibrillation at the beginning of ablation procedure;
* usage of 'single shot' devices.

Primary outcomes:
measure: Atrial fibrillation within the first 7 days after ablation
timeFrame: within the first 7 days after ablation
Secondary outcomes:
measure: Atrial fibrillation within 6 months after ablation
timeFrame: 6 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cariology of Medcial University of Warsaw
state: Mazowieckie
Study officials:
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Marcin D Grabowski, PhD
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Paweł Balsam, PhD
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Piotr Lodziński, PhD
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Grzegorz Opolski, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03766659: EUS-FNB With MOSE vs EUS-FNA With ROSE
Official title: Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International multicenter prospective randomized comparative study.
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.

In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.

Detailed description: The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 80 years
* Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter

Exclusion Criteria:

* Coagulopathy
* Altered anatomy
* Contraindications for conscious sedation
* Pregnancy
* Those who cannot provide informed consent

Primary outcomes:
measure: Diagnostic yield
timeFrame: 1 month after Procedure
Secondary outcomes:
measure: morbidity rate
timeFrame: 1 month after Procedure
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery; The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT01097759: LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy
Official title: LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapsed Hemorrhoids
Keywords: hemorrhoids
prolapsed
hemorrhoidectomy
Hemorrhoidopexy
LigaSure
Stapled
Lead sponsor: Kuwait Oil Company Ahmadi Hospital
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2010-04-02
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.

Brief summary: This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

Detailed description: The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.

Eligibility criteria: Inclusion Criteria:

* Adult (above 18 years)
* With prolapsed hemorrhoids (grades III or IV)

Exclusion Criteria:

* Complicated hemorrhoid
* Coexisting perianal disease
* Previous perianal surgery
* Unfit for general anesthesia
* Pregnancy
* History of bleeding tendency

Primary outcomes:
measure: Assessment of postoperative pain
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of postoperative complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahmadi
country: Kuwait
facility: Ahmadi Hospital
Study officials:
affiliation: Professor of Surgery, Faculty of Medicine, Alexandria University
name: Mahmoud F Sakr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: