louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02740088: 18F-NaF Uptake and Aortic Stenosis Progression
Official title: Clinical Value of 18F-sodium Fluoride Uptake at the Aortic Valve for Prediction of the Progression in Patients With Moderate Aortic Stenosis: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed as "moderate aortic stenosis" by echocardiography

Brief summary: This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis.

Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.

Detailed description: Recent studies demonstrated 18F-sodium fluoride (NaF) uptake activity as a marker of early-stage calcification. Although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. Limited studies exist regarding the usefulness of 18F-NaF uptake at aortic valve for prediction of stenosis progression.

Patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. Enrolled participants will undergo baseline 18F-NaF PET/CT within 6 weeks of baseline echocardiography and followed up for 1 year. After 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography.

The objective of the study is to test whether baseline 18F-NaF uptake activity predict AS progression.

Eligibility criteria: Inclusion Criteria:

* over 20 years old
* moderate aortic stenosis

Exclusion Criteria:

* age \< 20 yrs
* pregnant women

Primary outcomes:
measure: mean PG
timeFrame: AS severity progression after 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ho-Joong Youn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295488: Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
Official title: Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hymenoptera Allergy
Keywords: hymenoptera puncture
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen..

The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test.

The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen.

Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years and below 75 years age
* Patient who presented a generalized allergic reaction after an puncture of a hymenoptera
* Patient with positive skin tests against the venom of a hymenoptera
* Patient with positive specific IgE against the venom of a hymenoptera • to which an indication of accelerated desensitization was chosen in day hospitalization
* Information and consent signed by the patient
* Patient affiliated to french social security system
* For women of childbearing age, taking an effective contraceptive.

Exclusion Criteria:

* Patients with the following diseases: Mastocytosis, systemic infection or hospitalization within 4 weeks before inclusion, chronic inflammatory disease, cancer, unbalanced asthma, immune deficiency
* Patients on beta-blocker, following another specific immunotherapy, or ongoing immunosuppressive therapy.
* Pregnant or lactating
* People placed under judicial protection
* Patient participating or having participated in another biomedical research within six months

Primary outcomes:
measure: Evolution of basophil activation test value
timeFrame: Day 1 - 3h30
Secondary outcomes:
measure: Correlation between results of activation basophil test results and tolerance
timeFrame: Day 1 - 5h30
measure: Evolution of basophil surface markers
timeFrame: Day 1 - 5h30
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: UH Rouen
name: Luc THIBERVILLE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541488: Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Number of participants with clinically relevant findings in physical examination
timeFrame: up to 14 days postdose
measure: Number of participants with clinically relevant findings in vital signs
timeFrame: up to 14 days postdose
measure: Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
timeFrame: up to 14 days postdose
measure: Number of participants with significant changes from baseline laboratory measurements
timeFrame: up to 14 days postdose
measure: Number of participants with adverse events
timeFrame: up to 14 days postdose
measure: Assessment of tolerability by investigator
timeFrame: up to 14 days postdose
Secondary outcomes:
measure: Cmax (maximum measured concentration of BI 1021958 in plasma)
timeFrame: up to 72h postdose
measure: area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
timeFrame: up to 72h postdose
measure: AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
timeFrame: up to 72h postdose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1310.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03894488: Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients
Official title: Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GVHD - Graft-Versus-Host Disease
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2019-03-28
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients receiving HSCT within the year at SCMC

Brief summary: This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* Age ≤ 18 years old;
* Receiving HSCT;
* Legal guardians fully understand and sign informed consent.

Exclusion Criteria:

* Receiving secondary transplantation;
* Cannot give informed consent or not willing to enroll the study.

Primary outcomes:
measure: Positive rate of FilmArray GI test before and post-HSCT
timeFrame: 31 days after HSCT
measure: Compare the FilmArray GI test results generated from the same patients in different time points
timeFrame: 31 days after HSCT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06848088: A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
Official title: Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Melanoma
Keywords: Advanced Skin Cancer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).

The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).


Eligibility criteria: Key Inclusion Criteria:

1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)

Key Exclusion Criteria:

None

Note: Other protocol-defined Inclusion/ Exclusion criteria may apply

Primary outcomes:
measure: Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613
timeFrame: Up to 4 years
Secondary outcomes:
measure: Progressive-Free Survival (PFS)
timeFrame: Up to 4 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 4 years
measure: Duration of Response (DOR)
timeFrame: Up to 4 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 4 years
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 4 years
measure: Severity of SAEs
timeFrame: Up to 4 years
measure: Incidence of treatment-related AEs
timeFrame: Up to 4 years
measure: Severity of treatment-related AEs
timeFrame: Up to 4 years
measure: Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: San Antonio
country: United States
facility: South Texas Oncology And Hematology
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT05648188: A2R and Ectonucleotidases Expression in Lung Cancer Circulating Tumor Cells
Official title: Assessing the Expression of A2R Receptors and CD39 and CD73 Ectonucleotidases on Circulating Tumour Cells of Non-small Cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 0
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: Patients operated for a localized NSCLC (IA-IIB stage) in Nice University Hospital, Thoracic Surgery service.

Brief summary: Early non-small cell lung cancer (NSCLC), treated by surgery or radiotherapy in the case of inoperability, relapses in almost 50% of cases. Circulating tumour cells (CTCs), which can be detected before surgery, represent a promising prognostic tool, but the markers characterising their aggressiveness remain to be determined. The NSCLC microenvironment, in which purinergic signalling is a key pathway, controls tumour development. Adenosine derived from the action of CD39 and CD73 ectonucleotidases hydrolysing extracellular ATP, induces immunosuppression of NSCLC by activating A2R receptors. The expression and prognostic relevance of A2R, CD39 and CD73 on CTCs is unknown. The objectives are to (i) compare the expression of A2R and CD39 and CD73 on primary tumour cells and CTCs of patients operated on for early NSCLC, (ii) correlate these data with molecular characteristics and clinical response, (iii) determine on lung cancer lines whether irradiation impacts on the expression of A2R, CD39 and CD73. This work could contribute to the identification of new theranostic biomarkers.


Eligibility criteria: i) Inclusion criteria:

* Patient of legal age (\>18 years), any gender,
* operated on for stage (IA to IIB) non-small cell lung cancer (NSCLC)

ii) Exclusion criteria:

* Patient with any other active cancer.
* Lack of evaluable material.

Primary outcomes:
measure: Ex vivo expression of A2R (adenosine receptor), CD39, CD73 and P2RX7 on NSCLC and CTC
timeFrame: At inclusion
Secondary outcomes:
measure: In vitro impact of radiation therapy on the A2R, CD39, CD73 expression by cells lineage
timeFrame: At inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Jonathan BENZAQUEN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274088: The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.
Official title: The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IOL, Cataract
Keywords: multifocal IOL, optical quality, angle alpha
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of the clinic

Brief summary: Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

Detailed description: In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Eligibility criteria: Inclusion Criteria:

* corneal astigmatism less than 1 diopter

Exclusion Criteria:

* ocular pathology others than cataract

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 Month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mihaltz K, Vecsei-Marlovits PV. The impact of visual axis position on the optical quality after implantation of multifocal intraocular lenses with different asphericity values. Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.
Clinical trial NCT02304588: Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
Official title: Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Foot
Lower Limb Ischemia
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.


Eligibility criteria: Inclusion Criteria:

* the age of 30-78 years old, men and women there is no limit.
* in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
* with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
* treatment on a voluntary basis, and sign the informed consent.

Exclusion Criteria:

* with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
* clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
* the prodrome of acute infectious diseases.
* participated in clinical subjects within three months before test.
* adherence is poor, can not complete the course.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Relative Wound Area Regression of 40% or More at 6 Week
timeFrame: 6 week
Other outcomes:
measure: Reduced pain
timeFrame: 6 months after treatment
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: xiaobing FU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069288: Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock
Official title: Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Septic Shock
Keywords: fludrocortisone
pharmacology
septic shock
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 0
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: Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.


Eligibility criteria: Inclusion Criteria:

* Patients over than 18 years old
* Septic shock
* Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
* Written informed consent

Exclusion Criteria:

* Corticotherapy
* Known allergy to Fludrocortisone
* Esophageal or gastric disease
* Pregnant woman
* Inclusion in another clinical trial

Primary outcomes:
measure: Norepinephrine-mean arterial pressure dose-response relationship
timeFrame: 1.5 h after administration
Secondary outcomes:
measure: Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
timeFrame: During 3 h after administration
measure: Central aortic pressures, Augmentation Index (Aix).
timeFrame: During 3 h after administration
measure: Arterial stiffness: Carotid-femoral Pulse Wave Velocity
timeFrame: During 3 h after administration
measure: Humeral diameter and distensibility
timeFrame: During 3 h after administration
measure: Gastric mucosal perfusion
timeFrame: During 3 h after administration
measure: Plasma electrolytes, blood glucose, serum creatinine
timeFrame: Each hour during 3 h after administration
measure: Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations
timeFrame: Each hour during 3 h after administration
measure: Urinary electrolytes excretion
timeFrame: Each hour during 3 h after administration
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Réanimation Chirurgicale - Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Bruno LAVIOLLE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Eric BELLISSANT, MD, PhD
role: STUDY_CHAIR
References: