louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01304706: Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
3. Ability and willingness to comply with the treatment and follow up procedures.
4. Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

1. Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent \> 8 diopters), macular degeneration)
4. Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)
5. Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
6. History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
7. History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
8. Any lens opacity which significantly impairs vision, in the opinion of the investigator.
9. Peripheral retinal detachment in prospective area of insertion
10. Participation in another clinical trial within 12 weeks before the screening visit or during the study

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alpharetta
country: United States
state: Georgia
Study officials:
References:
Clinical trial NCT03514706: Effect of PCV and VCV on Extravascular Lung Water
Official title: The Ultrasound Estimation of Extravascular Lung Water in Volume Controlled Versus Pressure Controlled Ventilation After One Lung Ventilation in Thoracoscopic Surgery. A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extravascular Lung Water
Keywords: Extravascular lung water
one lung ventilation
volume controlled ventilation
pressure controlled ventilation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adult patients scheduled for elective thoracic surgery with one lung ventilation will be included in the study. Patients will be randomly allocated into one of two groups:

Group V: will receive volume controlled mechanical ventilation. Group P: will receive pressure controlled mechanical ventilation.
Primary purpose: SCREENING

Brief summary: Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow pattern. However, this high peak inspiratory flow rate might also provoke lung injury via shearing and traction forces on the alveoli. Extravascular lung water describes water within the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by B-lines provides a reliable and easy alternative.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged (18-60 years), undergoing elective thoracoscopic surgery with one lung ventilation

Exclusion Criteria:

* Emergency surgeries.
* Left Ventricular ejection fraction less than 40%.
* Any patient known to have pulmonary hypertension
* Patients with preoperative congestive heart failure, cardiogenic shock, preoperative pulmonary edema
* Hepatic patients (liver functions double the upper reference range)
* Morbid obesity (BMI \> 40).
* Renally impaired patients with creatinine more than 2 mg/dl.
* Any patient with respiratory dysfunction (FEV1\<60% of the expected).
* Any patient with previous thoracic surgery.
* One lung ventilation more than 2 hours

Primary outcomes:
measure: Lung ultrasound score
timeFrame: change of lung ultrasound scores introperatively during double lung and single lung ventilation and after 2 hours postoperatively compared to baseline scores before anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Ainy faculty of medicine. Cairo University
Study officials:
affiliation: Kasr Al-Ainy Faculty of Medicine
name: Hisham Hosny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06365606: Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
Official title: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis Infection
Syphilis
Keywords: syphilis rapid test
syphilis point of care tests
syphilis antibody test
iStatis Syphilis Ab Test
iStatis Syphilis Antibody Test
Lead sponsor: bioLytical Laboratories
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at

Detailed description: A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.

Eligibility criteria: Inclusion Criteria:

* Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:

  o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
* Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria:

* Participant younger than 18 years old
* Participants unable to provide written informed consent
* Participants currently undergoing treatment

Primary outcomes:
measure: Sensitivity and specificity of the iStatis Syphilis Ab Test
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hillcrest
country: South Africa
facility: Epicentre Health Research
state: KwaZulu Natal
Study officials:
References:
Clinical trial NCT06950606: Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery
Official title: Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypotension During Surgery
Keywords: Stressed volume
Vasopressor
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 238
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia


Eligibility criteria: Inclusion Criteria:

Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes

Exclusion Criteria:

Patients with the following exclusion criteria:

* Surgery in which pneumatic calve compression is indicated according to ERAS guidelines
* Surgery which interferes with the installation or correct function of PLC
* Sepsis (according to current Sepsis-3 definition)
* Pregnancy
* Congestive heart failure NYHA III/IV
* American Society of Anesthesiologists (ASA) physical status classification V or VI
* Interference of PLC and patient positioning (e.g.; extreme Trendelenburg positioning, lithotomy positioning)
* Contraindications for the use of PLC according to the German guideline13 (e.g., extensive thrombophlebitis, thrombosis or suspected thrombosis of the lower limbs, erysipelas, acute phlegmon, limb compartment syndrome, severe uncontrolled arterial hypertension, lymphatic drainage disorder proximal to PLC, extensive open soft tissue trauma, autoimmune blistering skin conditions such as IgA bullous dermatosis or bullous pemphigoid)

Primary outcomes:
measure: Average norepinephrine infusion rate
timeFrame: Intraoperative
Secondary outcomes:
measure: Average norepinephrine infusion rate
timeFrame: Perioperative
measure: Amount of hypotensive events
timeFrame: Intraoperative
measure: Lowest MAP
timeFrame: Intraoperative
measure: Cumulative amount of hypotensive time
timeFrame: Intraoperative
measure: Time-weighted average MAP <65 mmHg
timeFrame: Perioperative
measure: Crystalloid fluid application
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT02940106: Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device
Official title: Investigation of the Clinical Pregnancies Obtained After Cryopreservation of Donor Oocytes With an Open or Closed Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: oocyte cryopreservation
closed vitrification
open vitrification
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This randomized pilot study will assess if there is a difference in clinical pregnancies using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.

Detailed description: Oocyte cryopreservation was optimized by the use of a new technique: vitrification. Vitrification can be performed using either open devices (where the oocytes are in direct contact with the liquid nitrogen) or closed systems (where the oocytes are never in contact with liquid nitrogen). Previous studies have associated the use of open devices to higher oocyte survival rates and better embryo development. However, any beneficial effect on clinical pregnancy rates is yet to be proven. Hence, the objective of this study is to compare the clinical pregnancy rates of open and closed oocyte vitrification devices.

Eligibility criteria: Inclusion Criteria:

* this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study

Exclusion Criteria:

* women who do not consent or that cannot comprehend the investigational nature of the study

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 7 weeks
Secondary outcomes:
measure: survival
timeFrame: 1 week
measure: fertilization
timeFrame: 1 week
measure: embryo development
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Neelke De Munck, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2.
Clinical trial NCT00347906: Photodynamic Therapy (PDT) Versus Transpupillary Thermotherapy (TTT) in Occult Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (AMD)
Official title: Photodynamic Therapy Versus Transpupillary Thermotherapy in Occult CNV in Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effect of PDT and TTT for the treatment of subfoveal occult CNV in age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* \> 55 years of age,
* Subfoveal occult only CNV due to AMD,
* \< 4 disc areas or \> 4 disc areas
* VA \< 0.4

Exclusion Criteria:

* Sign of classic CNV,
* CNV in other diagnoses than AMD,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Christina I Frennesson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04199806: Retrospective Study of Patient Surveys
Official title: Retrospective Study of Patient Surveys of MMS Experience
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:

1. Patient demographics
2. Treatment patterns
3. Patient feedback and overall experience with MMS treatment


Eligibility criteria: Inclusion Criteria

* Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)
* Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.

Exclusion Criteria

• There are no exclusion criteria for this study.

Primary outcomes:
measure: Efficacy Endpoint: Overall Experience Questionnaire
timeFrame: Immediately post subjects final treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zeltiq Aesthetics
name: Kerrie Jiang, NP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04455906: Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
Official title: Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-07-02
Enrollment: 111
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: atopic dermatitis

Brief summary: This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.

Detailed description: For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.

Eligibility criteria: Inclusion Criteria:

1. Male or female participants ≥6 to 65 yrs of age
2. Meet AD Standard Diagnostic Criteria

Exclusion Criteria:

1. Enrollment in another clinical trial
2. Hypersensitivity to an agent used for the skin decolonization protocol
3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)
4. Phototherapy for AD within 4 weeks
5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
6. Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days
7. Bleach baths within 7 days of the first Visit
8. Use of oral or topical antibiotics within 21 days of the beginning of the study
9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
13. Febrile illness at time of visits
14. Suspected immune deficiency or family history of primary immunodeficiency

Primary outcomes:
measure: atopic dermatitis severity
timeFrame: baseline, only 1 time point
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MD. MS.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418206: Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Official title: Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid 19
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)
Primary purpose: PREVENTION

Brief summary: The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years,
* patients with confirmed SARS-Cov2 infection (RT PCR positive)
* or patients suspected (evocative chest scanner)
* OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
* OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)

Exclusion Criteria:

* pregnant or breastfeeding female

Primary outcomes:
measure: IgA specific cells of SARS
timeFrame: At 7 days
Secondary outcomes:
measure: OMS progression scale
timeFrame: At 7 days
Other outcomes:
Locations:
city: Antibes
country: France
facility: CH Antibes
state: Alpes Maritimes
city: Cannes
country: France
facility: Ch Cannes, Pneumologie
state: Alpes Maritimes
city: Grasse
country: France
facility: Ch Grasse
state: Alpes Maritimes
city: Nice
country: France
facility: CHU de nice
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice, pneumologie
name: LEROY Sylvie
role: PRINCIPAL_INVESTIGATOR
References: