louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04068272: Safety of Bosentan in Type II Diabetic Patients
Official title: Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Retinset SL
Sponsor class: INDUSTRY
Collaborators: name: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
First posted: 2019-08-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety of topical Bosentan in Type II Diabetes patients

Detailed description: The study is a Phase I, masked, placebo controlled clinical trial to assess safety of topical Bosentan in Type II Diabetes patients with no diabetes retinopathy

Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* Type II Diabetes Mellitus;
* 18 or more years old

Exclusion Criteria:

* Pregnant or breastfeeding Women
* Known allergy or intolerance to investigational product or any of its excipients
* Severe corneal abnormalities
* Any relevant ocular / ophthalmic pathology that may put study results at risk in the opinion of Principal Investigator
* Any sign or symptom of Diabetes Retinopathy
* Any ocular surgery in the 6 previous months to study inclusion
* Uncontrolled diabetes in the previous 3 months to inclusion or HbA1c levels ≥ 9% at baseline.
* Oxford Scale or OSDI scores compatible with study failure at inclusion visit. (Oxford ≥ 5 or OSTDI ≥ 13)
* Previous hepatopathy history or signs of hepatopathy at baseline.
* Contact lens use
* Actual treatment with the commercially available presentation

Primary outcomes:
measure: Epitheliopathy
timeFrame: 1 month
Secondary outcomes:
measure: Presence of ocular discomfort
timeFrame: 1 month
measure: Anterior segment inflammation
timeFrame: 1 month
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Valladolid
country: Spain
facility: IOBA
Study officials:
References:
Clinical trial NCT04549272: Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Official title: Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patent Foramen Ovale
Keywords: Magnetic Resonance Imaging
Vascular Cognitive Impairment
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 100 subjects of both genders will be included in the study.

Brief summary: Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 and ≤ 65 years
* patients with patent foramen ovale
* written informed consent

Exclusion Criteria:

* previous IMA, stroke or TIA
* arrhythmia or severe cardiac disease
* hypertension, diabetes or renal disease
* psychiatric disease
* neurological or neurodegenerative disease
* dementia
* assumption of drugs known to interfere with cognitive function
* inability to be subjected MRI analysis
* participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Primary outcomes:
measure: Measurement of percentage change in diffusion parameters of the white matter
timeFrame: At Enrollment
Secondary outcomes:
measure: Quantification of the degree of shunt of the patent foramen ovale
timeFrame: At Enrollment
measure: Detection of cognitive decline by decrease of MoCA score
timeFrame: At Enrollment
measure: Detection of a non-invasive retinal screening
timeFrame: At Enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01287572: Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit
Official title: Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Conscious Sedation
Keywords: TcCO2
sedation
procedure
PICU
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-01
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit and undergoing minor procedures

Brief summary: Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2.

The rise in CO2 levels is not well described and unpredicted. In this study the investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a device recently approved for clinical use. The hypothesis is ventilation of patients undergoing conscious sedation is compromised and CO2 levels might rise significantly to levels that potentially can effect hemodynamics.

In order to avoid hemodynamic changes proper and routine monitoring is recommended.


Eligibility criteria: Inclusion Criteria:

* pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit
* patients requiring minor surgical procedures (e.g. bronchoscopy, central venous line placement, lumbar puncture, intracranial pressure monitoring device insertion)

Exclusion Criteria:

* skin disease
* burns to thorax

Primary outcomes:
measure: TcCO2 level
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Yakov Sivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Efraim Sadot, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00807872: Radioimmunoimaging of AL Amyloidosis
Official title: Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Amyloidosis
Keywords: Radioimmunoimaging
AL Amyloidosis
PET/CT
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: FDA Office of Orphan Products Development
First posted: 2008-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed description: To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of AL amyloidosis

Exclusion Criteria:

* New York Heart Association class IV
* patient on renal dialysis
* serum antibodies to mouse protein

Primary outcomes:
measure: Radioimmunoimaging of AL amyloid deposits by PET/CT
timeFrame: 10-14 days post infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee Graduate School of Medicine
name: Alan Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall JS, Kennel SJ, Stuckey AC, Long MJ, Townsend DW, Smith GT, Wells KJ, Fu Y, Stabin MG, Weiss DT, Solomon A. Radioimmunodetection of amyloid deposits in patients with AL amyloidosis. Blood. 2010 Sep 30;116(13):2241-4. doi: 10.1182/blood-2010-03-273797. Epub 2010 Jun 3.
Clinical trial NCT03845972: Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Official title: Effect of Ultrasound-guided Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saphenous Nerve Block
Regional Anesthesia Morbidity
Postoperative Pain
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research objective is to compare quadriceps strength by measuring maximal voluntary isometric contraction (MVIC) and risk of fall before and after subsartorial femoral triangle block (SSFTB)


Eligibility criteria: Inclusion Criteria:

* Eligible patients are all ASA class I-III, age 18-80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively

Exclusion Criteria:

* Exclusion criteria are patients who refuse to participate the study, morbid obesity (BMI ≥ 35 kg.m2), lower extremity neurological dysfunction, performing other peripheral nerve blocks, patients who cannot cooperate or measure MVIC, difference of quadriceps strength between two side of knees more than 10 percent, and SSFTB is not finally performed or failed block.

Primary outcomes:
measure: quadriceps strength
timeFrame: 30 minutes after SSFTB
Secondary outcomes:
measure: motor power of knee extension
timeFrame: 30 minutes after SSFTB
measure: perception of fall 30 minutes
timeFrame: 30 minutes after SSFTB
Other outcomes:
Locations:
city: Klong Luang
country: Thailand
facility: Ratibhorn Rangsee
state: Pratumthani
Study officials:
References:
Clinical trial NCT00177268: Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Official title: Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Eczema
Atopic Dermatitis
Keywords: Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Blood/tissue banking
eczema
atopic dermatitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with cutaneous t-cell lymphoma and/or Sezary syndrome and atopic dermatitis or eczema patients

Brief summary: This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.

Detailed description: The purpose of this study is to provide a central mechanism for monitoring access to peripheral blood, urine, and skin specimens obtained from CTCL, eczema, and atopic dermatitis patients to monitor:

* immunologic assays/flow cytometry
* tumor progression/regression
* genomic studies
* proteomic studies
* others germane to the advancement of CTCL treatment

Eligibility criteria: Inclusion Criteria:

* 18 or older
* able and willing to provide informed consent
* diagnosed with CTCL
* diagnosed with either atopic dermatitis or eczema

Exclusion Criteria:

* Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record

Primary outcomes:
measure: Proteomics of Cutaneous T-cell lymphoma
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Oleg E Akilov, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348368: Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder
Official title: Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Ectasia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children live in upper Egypt with high cylinder and no corneal scar.

Brief summary: Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study

Detailed description: Astigmatism is defined as, a refractive condition in which refractive light fails to form a focus on the retina, it accounts for about 13% of refractive errors. It is frequent and correctable cause of visual impairment in children whether associated with spherical errors or not.

Astigmatism, is the refractive error of the highest clinical importance, being associated with reduced visual acuity with subsequent development of refractive amblyopia.

High cylinder in children belong to areas of hot and dry climates, makes exclusion of keratoconus is mandatory. Population in the African continent, the Mediterranean countries, Central and South America, and the Indian subcontinent usually have the habit of eye rubbing because of bothering symptoms of dryness, itching, atopy, allergy and vernal keratoconjunctivitis, which is the severe form of allergic conjunctivitis.

Eye rubbing causes thinning of keratocyte and increases the prevalence of keratoconus.

Keratoconus in children (diagnosed before the age of eighteenth) is less common but more aggressive than that of the adults, due to the dynamic nature of the young cornea. Few studies in the literature reported the prevalence and incidence of keratoconus in children.

Pentacam is an advanced instrument with a rotating Scheimpflug camera for scanning the anterior and posterior corneal surfaces. Its measurements of the corneal thickness and posterior elevation have been proved to be of high reproducibility and repeatability.

Eligibility criteria: Inclusion Criteria:

- Upper Egypt children with high cylinder(refractive errorr).

Exclusion Criteria:

* Children below age of 7 years old (uncooperative), patients above age of 18 years old.Patients with corneal scars

Primary outcomes:
measure: Values anterior and posterior corneal elevation values by pentacam.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
affiliation: Assistant professor of ophthalmology, Sohag University
name: Elshimaa A.Mateen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935268: Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment
Official title: Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients wit infrarenal Aortic Aneurysms

Brief summary: The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches.

Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment.

Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.


Eligibility criteria: Inclusion Criteria:

* Infrarenal Aortic Aneurysm

Exclusion Criteria:

* Other Aneurysms

Primary outcomes:
measure: Survival
timeFrame: 1-60 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Frechen
country: Germany
facility: Egan Kalmykov
state: Please Select
Study officials:
affiliation: Ryazan State Medical University
name: Igor A Suchkov, Prof
role: STUDY_DIRECTOR
affiliation: Clinic of Vascular Surgery, Frechen
name: Egan Kalmykov, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06249568: Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery
Official title: Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fluid Therapy
Coronary Artery Bypass Surgery Patients
Lung Recruitment Maneuver
Keywords: fluid therapy
Coronary Artery Bypass Surgery Patients
Lung Recruitment Maneuver
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia

Brief summary: Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.

Detailed description: In order to evaluate the fluid deficit in patients undergoing coronary artery bypass surgery, researchers will measure stroke volume index, cardiac index and mean arterial pressure while the patients are in the lima position.

Then researchers will perform a lung opening maneuver (30mmHg for 30 seconds) and measure again.

researchers will measure again after the values return to normal. researchers will give patients balanced fluid at 3ml/kg and record their values.

Can researchers predict fluid response with lung opening maneuver?

Eligibility criteria: * Inclusion Criteria:
* 1-ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
* Exclusion Criteria:
* 1. Be younger than 18 years old, be over 80 years old
* 2. Patients with an ASA score greater than 3
* 3. EF\<40%
* 4. Those with contraindications to anesthetic drugs
* 5. Patients with BMI\>30
* 6. Patients who did not want to participate in the study
* 7. Right ventricular dysfunction
* 8. COPD(Chronic obstructive pulmonary disease)
* 9. Bullous lung disease
* 10. Moderate to severe PHT
* 11. Severe kidney or liver disease
* 12. Patients with hemodynamic instability in the perioperative period
* 13. Pregnancy

Primary outcomes:
measure: Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery.
timeFrame: from start to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
Study officials:
References:
Clinical trial NCT05710068: Effects of RF Microneedle on Photoaging Skin
Official title: RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pigmentation
Pigmentation Disorder
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split lesion study
Primary purpose: TREATMENT

Brief summary: Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.


Eligibility criteria: Inclusion Criteria:

* Adult more than 19 years old
* Melasma clinically diagnosed by three dermatologists

Exclusion Criteria:

* Aesthetic medical procedures in three months prior to the study
* Use of topical depigmenting agents in three months prior to the study
* Pregnant or lactating

Primary outcomes:
measure: Change of modified melasma area severity index score
timeFrame: Every 1 month up to 8 months
measure: Change of lightness value
timeFrame: Every 1 month up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: