louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03630562: Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
Official title: Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment.
* Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months
* Signature of informed consent
* Affiliation to the French social security system

Exclusion Criteria:

* Pregnant or nursing patient (a urinary pregnancy test will be performed)
* Systemic treatment with anti-VEGF
* Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye.
* Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis.
* Diabetes Mellitus
* High Myopia
* Simultaneous participation in another clinical research protocol in exudative AMD
* Person under guardianship, under curatorship, deprived of liberty

Primary outcomes:
measure: Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months
timeFrame: At Month 3
Secondary outcomes:
measure: Dose of VEGF in the aqueous humor of patients with exudative AMD
timeFrame: At Day 0, Month 1, Month 2, Month 3
measure: Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD
timeFrame: At Day 0, Month 1, Month 2, Month 3
measure: Measurement of visual acuity with Snellen chart
timeFrame: At Day 0, Month 1, Month 2, Month 3
measure: Measurement of visual acuity with ETDRS visual acuity chart
timeFrame: At Day 0, Month 1, Month 2, Month 3
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur 2 - Service d'Ophtalmologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Prof. Stéphanie BAILLIF, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724162: Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis
Official title: Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory; Change
Microcirculation
Keywords: cancer oesophagus
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only subjects selected for thoracolaparoscopic operation shall be included in this study.

Brief summary: The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.

Detailed description: - Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.

Eligibility criteria: Inclusion Criteria:

Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.

Exclusion Criteria: Patients who do not give written consent will not be included.

Primary outcomes:
measure: Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Department of vascular surgery, Oslo University Hospital
Study officials:
References:
Clinical trial NCT00231062: Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Official title: Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Keywords: sinusitis
rhinitis
sinus surgery
maxillary
ethmoid
sphenoid
frontal
FESS
sinuplasty
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2005-10-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

Detailed description: Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.

The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and greater
2. Both male and female patients eligible
3. Diagnosis of chronic sinusitis that is not responsive to medical management
4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)

Exclusion Criteria:

1. Extensive sinonasal polyps
2. Extensive previous sinonasal surgery
3. Extensive sinonasal osteoneogenesis
4. Cystic fibrosis
5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
8. Ciliary dysfunction
9. Pregnant females

Primary outcomes:
measure: Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
timeFrame: 24 weeks
measure: Number of Participants With Adverse Events Following Sinuplasty Procedure
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Participants Experiencing Relief of Sinus Symptoms
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Christopher Church, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756791: Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Official title: Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mastectomy; Lymphedema
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

Detailed description: To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.

Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.

There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years.
* Provision of signed informed consent prior to any study-specific procedure.
* Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.

Exclusion Criteria:

* Age \>80 years
* History of chronic pain or drug treatment abuse
* Depression, psychiatric morbidity or mal-adaptive coping behavior
* Neuropathy
* Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
* Chronic or acute skin infection of the lateral thorax
* Hypersensitivity to ropivacaine
* Severe hepatic or renal disease
* Refuse to participate to the study
* Pregnancy

Primary outcomes:
measure: The use of opioids in the postoperative period
timeFrame: 24 hours
Secondary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 24 hours
measure: Degree of arm mobilization
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT03296891: Point of Care Ultrasonography In The Management of Shock: A Pilot Study
Official title: Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock
Hypotension
Keywords: Ultrasonography
Point-of-care ultrasound
Resuscitation
Critical Care
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 50
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: This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC).


Eligibility criteria: Inclusion Criteria:

Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:

1. Lactate greater than or equal to 2.2 mmol/L
2. AKIN stage I or greater or Urine output less than 0.5 cc/hr
3. Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock
4. Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.

Exclusion Criteria:

1. Pregnant patients
2. Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours
3. Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products).
4. Patients post cardiac arrest who are not obeying commands

Primary outcomes:
measure: Recruitment rate
timeFrame: averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Successful randomization rate
timeFrame: 28 days
measure: Protocol adherence rate
timeFrame: 28 days
measure: Contamination rate
timeFrame: 28 days
measure: Revoked deferred consent rate
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Ventilator free days
timeFrame: 28 days
measure: Continuous renal replacement therapy free days
timeFrame: 28 days
measure: Vasoactive medication free days
timeFrame: 28 days
measure: Cumulative fluid balance
timeFrame: 7 days
measure: Acute Kidney Injury (AKIN) stage
timeFrame: 7 days
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Center - Critical Care Trauma Center
state: Ontario
Study officials:
References:
Clinical trial NCT04059991: Antibodies in Repeated Influenza Vaccination (ARIVA) Study
Official title: Antibodies in Repeated Influenza Vaccination (ARIVA) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Response Impaired
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: University of Oxford
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2019-08-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Viruses with high mutation rates, such influenza or HIV, pose a major challenge for vaccine design. The current influenza vaccination strategy of yearly vaccination with adapted strains aims to maximally diversify the antibody immune response to prevent viral escape. There is, however, growing evidence, that repeated vaccination with very similar viral proteins might limit, instead of broaden, diversification and thereby reduce vaccine efficacy.

The ARIVA Study prospectively studies the immunological impact of repeated influenza vaccination on viral variant recognition and antibody responses in healthy subjects cross-sectionally and over three consecutive vaccination seasons.


Eligibility criteria: Inclusion Criteria:

* influenza vaccination (QIIV) independent of the study
* age \>18 yo

Exclusion Criteria:

* no vaccination
* current acute illness

Primary outcomes:
measure: Influenza specific Antibody Responses
timeFrame: Change between baseline and 28 days post-vaccination will be compared
Secondary outcomes:
measure: Plasmablast generation
timeFrame: Day 7 post-vaccination
measure: BCR Repertoire composition
timeFrame: Cross sectional comparison of the BCR repertoire characteristics day 0 and day 28
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital Basel, Medical Outpatient Clinic
name: Christoph T Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185491: Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )
Official title: Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.


Eligibility criteria: Inclusion Criteria:

* Major (adult subject over 18), with no upper age limit
* Enrolled in a social security scheme or beneficiary of such a scheme
* Agreement to participate (informed, written consent)
* Established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion
* Regular user of a glucose monitoring system for at least 3 months.

Non inclusion Criteria:

* Known hemoglobinopathy
* Inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit.
* Stage 5 renal insufficiency (CKD-EPI less than 15 mL/min/1.73 m2)
* Pregnant or breast-feeding
* Major under guardianship, curatorship or safeguard of justice
* Any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study

Exclusion criteria:

* Treatment with corticosteroids in the 3 months preceding the visit
* Unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator
* Pregnancy started

Primary outcomes:
measure: Coefficient of variation of individual HGI distribution
timeFrame: 12 months
Secondary outcomes:
measure: Coefficient of variation of the individual distribution of the albumin glycation index
timeFrame: 12 months
measure: Glycation gap, determined from comparison between HbA1C measured and HbA1C derived from glycated albumin
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: La Rochelle
country: France
facility: CH de La Rochelle
city: Le Mans
country: France
facility: CH du Mans
city: Nantes
country: France
facility: CHU de Nantes
city: Poitiers
country: France
facility: CHU de Poitiers
city: Pontoise
country: France
facility: Hôpital NOVO
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Hélène AUFFRET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01237691: An Evaluation of California's Experiment With HOPE
Official title: Phase 1 Study of California's HOPE Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drugs of Abuse
Keywords: drug use
drug arrests
incarceration
Lead sponsor: Pepperdine University
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: University of California, Los Angeles
First posted: 2010-11-09
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group.

Detailed description: The California HOPE pilot program is being implemented under the authority granted in Penal Code 5058.1. The phase I evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by California parolees assigned to the study group compared with parole-as-usual.

Eligibility criteria: Inclusion Criteria:

* Assigned to the Sacramento Metro IV Parole Unit.
* Released from a term of return-to-custody for a violation for, or involving, the use of drugs.
* Have a maximum controlling discharge date at least one year from the date of release from the return-to-custody term.

Exclusion Criteria:

* History of convictions for crimes that require registration under Penal Code Section 290.

Primary outcomes:
measure: Days incarcerated
timeFrame: 24 months
Secondary outcomes:
measure: % positive drug tests
timeFrame: 24 months
measure: %Missed
timeFrame: 24 months
measure: Revocation rate
timeFrame: 24 months
measure: New arrests
timeFrame: 24 months
measure: Perceptions of risk of detection
timeFrame: 24 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento Metro IV Parole Unit.
state: California
Study officials:
affiliation: Pepperdine University
name: Angela Hawken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771091: Head-perineum Distance and Delivery Mode
Official title: Correlation Between Head Perineum Distance Measured by Trans-périneal Ultrasound and Delivery Mode in Patient in the Second Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancies
Obstetric Labor
Keywords: Head perineum distance
ultrasound measure
delivery mode
instrumental delivery
spontaneous delivery
pushing maternal efforts
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).

Detailed description: Head-perineum distance measured by transperineal ultrasound is a simple and well-known tool to help diagnose the fetal head engagement and predictive value to instrumental extraction succeeds.

It is performed in labor room and is a non-invasive test, realized on a healthy skin.

The investigators performed a systematical measure of head perineum distance at the beginning of the expulsive labor phase. The investigators made the hypothesis, based on our clinical experience, that starting expulsive labor phase with head perineum distance greater than forty five millimeters, lead to an increased risk of instrumental extraction and therefore an increase in materno-fetal morbidity and mortality.

The investigators sought to evaluate the optimal head perineum distance at the beginning of expulsive efforts.

Eligibility criteria: Inclusion Criteria:

* Single pregnancy
* In labor (spontaneous or induced)
* Term superior at 37 SA
* Delivery by summit presentation

Exclusion Criteria:

* Non single pregnancy
* Suspected malformative abnormalities in the unborn fetus
* Refusal of participation
* Minor patient
* Adult patient subject to legal protection or patient deprived of liberty
* Poor French language understanding

Primary outcomes:
measure: Delivery mode
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Maela Le Lous, MD
role: PRINCIPAL_INVESTIGATOR
References: