louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00675207: Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
Official title: Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular hypertension
adjunctive treatment
prostaglandin
prostaglandin analog
brimonidine
dorzolamide
brinzolamide
alpha agonist
carbonic anhydrase inhibitor
intraocular pressure
Lead sponsor: Northwestern Ophthalmic Institute S.C.
Sponsor class: OTHER
Collaborators: name: Research to Prevent Blindness
First posted: 2008-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension.
* Must be over 40 years of age.
* Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).

Exclusion Criteria:

* History of angle closure or narrow angle.
* Previous intraocular surgery.
* Laser trabeculoplasty within 3 months prior to screening.
* History of uveitis or intraocular inflammation.
* Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
* Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
* Women of childbearing age who are pregnant or not using contraception.

Primary outcomes:
measure: Intraocular pressure
timeFrame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Glenview
country: United States
facility: Northwestern Ophthalmic Institute S.C.
state: Illinois
Study officials:
affiliation: Northwestern Ophthalmic Institute S.C.
name: Thomas E. Bournias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820507: Extubation Failure Prevention in High Risk Patients by High-flow Conditioned Oxygen Therapy vs. Standard Oxygen Therapy
Official title: Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Keywords: Post-extubation respiratory failure
Endotracheal intubation
Mechanical ventilation
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named "High flow conditioned oxygen therapy (HFCO)". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.


Eligibility criteria: Inclusion Criteria:

* Patients mechanically ventilated for \> 48 hours and at least one of the following:
* \>65 years
* cardiac failure as the primary indication of mechanical ventilation
* Chronic Obstructive Pulmonary Disease
* Severity score (APACHE II \>12 points) the extubation day
* Body Mass Index \>30
* inability to manage respiratory secretions
* 1 failed spontaneous breathing trial
* 1 comorbidity
* 7 days under mechanical ventilation

Exclusion Criteria:

* \<18 years
* tracheotomized patients
* recent facial or cervical trauma/surgery
* active gastro-intestinal bleeding
* lack of cooperation
* patients with any failed spontaneous breathing trial because of hypercapnia development.

Primary outcomes:
measure: Respiratory failure after extubation
timeFrame: 72 hours
Secondary outcomes:
measure: Survival
timeFrame: 90 days
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: ICU. Fundacio Althaia
state: Barcelona
Study officials:
affiliation: Fundacio Althaia
name: Rafael Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.
Clinical trial NCT01455207: From Uncomplicated Alcoholism to Korsakoff's Syndrome
Official title: From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholism
Alcohol Amnestic Disorder
Keywords: Magnetic Resonance Imaging
Positon Emission Tomography
Behavior
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: National Research Agency, France
First posted: 2011-10-19
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.


Eligibility criteria: Inclusion Criteria:

* Completed at least 8 years of education (primary school equivalent)
* Age-normal corrected hearing and visual acuity

Exclusion Criteria:

* documented loss of consciousness of over 30 minutes, documented compound skull fracture, or clear neurological sequelae of head trauma
* history of medical or neurological illness or trauma potentially affecting the CNS, e.g., stroke, multiple sclerosis, epilepsy, psychosurgery, insulin coma.
* active tuberculosis or history of or any malignancy requiring chemotherapy
* history of schizophrenia or bipolar disorder
* metal implantation (e.g., pacemakers) or other factors that preclude MRI scanning for subjects selected for the neuroimaging examination
* meet DSM-IV criteria for current (past 3 months) other Substance Abuse
* met DSM-IV criteria for other Substance Dependence
* Have used other substances more than 5 times in the past month

Primary outcomes:
measure: Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
timeFrame: one year
Secondary outcomes:
measure: treatment outcomes (sobriety or relapse)
timeFrame: one year
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT03713307: Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic - MICROSHOCK - RENAL
Official title: Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic Circulations; a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Septic Shock
Keywords: Septic shock
acute kidney injury
haemodynamic monitoring
microcirculation
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Royal Centre for Defence Medicine
First posted: 2018-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with early septic shock admitted to ICU

Brief summary: An observational study of the state of the renal and systemic circulations in patients with early septic shock. Both macro and microvascular parameters will be assessed using echocardiography, sublingual incident dark field video-microscopy and renal contrast enhanced ultrasound. Patients will be categorised by KDIGO degree of kidney injury at Day 7 and stratified. Haemodynamic and perfusion based variables over time for these groups will be compared to assess the impact of changes in same on the development of AKI. Lab based work to quantify renal injury biomarkers will also be undertaken.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years Within 48 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation

Exclusion Criteria:

Known intolerance to Sonovue or any other ultrasound contrast agent Acute Respiratory Distress Syndrome Pregnancy Breast Feeding mothers Patients not expected to survive 24 h in whom the intent of treatment is palliative

Primary outcomes:
measure: KDIGO AKI grade
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
citation: Watchorn J, Huang D, Bramham K, Hutchings S. Decreased renal cortical perfusion, independent of changes in renal blood flow and sublingual microcirculatory impairment, is associated with the severity of acute kidney injury in patients with septic shock. Crit Care. 2022 Sep 1;26(1):261. doi: 10.1186/s13054-022-04134-6.
Clinical trial NCT03363607: Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding
Official title: Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Indirect Bonding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.


Eligibility criteria: Inclusion Criteria:

* Patients seeking orthodontic treatment with fixed orthodontic appliance.
* Patients with full set of permanent teeth
* Good oral hygiene and periodontal condition.

Exclusion Criteria:

* Patients suffering from any periodontal disease.
* Patients with poor oral hygiene
* Enamel hypoplasia and hypocalcification
* Deep carious lesions / large restorations

Primary outcomes:
measure: Linear and angular Positioning of the brackets
timeFrame: Immediately after bonding
Secondary outcomes:
measure: Bonding failure of the brackets.
timeFrame: three months
measure: Chair side time
timeFrame: during the bonding procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00876707: Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses
Official title: Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cataract
Astigmatism
Keywords: wavefront
multifocal IOL
modulation transfer function
intraocular lenses
wavefront data
Visual performance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria:

* Any ocular diseases, such as:

  * corneal opacities or irregularity
  * dry eye
  * amblyopia
  * anisometropia
  * glaucoma
  * retinal abnormality
* Surgical complications
* IOL tilt
* IOL decentration greater than 0.4 mm (estimated by retroillumination)
* Incomplete follow-up

Primary outcomes:
measure: visual acuity, wavefront data and modulation transfer function
timeFrame: 30, 90 and 120 days after surgery
Secondary outcomes:
measure: contrast sensitivity
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
References:
Clinical trial NCT05695807: Carboxytherapy in the Treatment of Atrophic Scars
Official title: Efficacy of Carboxy Therapy Versus Fractional Laser CO2 Versus Platelet Rich Plasma in Atrophic Scars, a Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophic Scar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of CO2 versus fractional CO2 laser versus platelet rich plasma in treatment of atrophic scars using clinical assessment and ultrasonography


Eligibility criteria: Inclusion Criteria:

* traumatic and surgical scar

Exclusion Criteria:

* active infections

Primary outcomes:
measure: Modified Vancouver score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04757207: Pandemia And Exercise in Turkey in University Students of Turkey
Official title: The Effect of Pandemia on Making Exercise In University Students of Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedentary Behavior
Covid19
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 5474
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Being a university student
* Having sufficient devices (cell phone or computer) to access the electronic survey

Brief summary: The aim of this study is to determine to what extent university students' physical activities are affected by staying at home during the pandemia.

Detailed description: The aim of our study is to determine to what extent university students' physical activities are affected by staying at home during the pandemia considering that they spend hours working by a computer. The state of physical inactivities will be questioned by an online survey for Inernational Physical Activity Questionnaire (short form). Then average energy expenditure following stepping and/or exercise will be asked from health application of mobile phones.

Eligibility criteria: Inclusion Criteria:

* Being a university student
* Having sufficient device infrastructure (cell phone or computer) to access the electronic survey

Exclusion Criteria:

* Entering incorrect numbers for answers
* Those who have a disease / disability that prevents them from walking and exercising

Primary outcomes:
measure: International Physical Activity Score (short form) MEt-min/week
timeFrame: an average of 2 months, through study completion.
Secondary outcomes:
measure: Energy expenditure while stepping
timeFrame: an average of 2 months, through study completion.
measure: Energy expenditure while exercising
timeFrame: an average of 2 months, through study completion.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT04107207: Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
Official title: Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind crossover
Primary purpose: TREATMENT

Brief summary: This study's primary objective is to determine the ability of Kombucha to impact blood sugar levels in patients with diabetes mellitus type II. The secondary objective is to determine the ability of Kombucha to impact blood pressure, and quality of life measures as measured by uniform questionnaire that includes: gut health, colds, infections, headaches, sleep, anxiety (GAD2), depression (PHQ2), skin health.


Eligibility criteria: Inclusion Criteria:

1. S/he is above the age of 18
2. S/he has the ability to read, speak and write English
3. S/he has telephone access
4. S/he is diabetic and willing to check blood sugar levels every day
5. Hb A1c \>7%
6. Possesses a glucometer

Exclusion Criteria:

1. Allergy to kombucha ingredients
2. Drinks kombucha regularly (\>3time per week)

Primary outcomes:
measure: Blood Sugar Levels
timeFrame: 10 weeks
Secondary outcomes:
measure: Gut health
timeFrame: 10 weeks
measure: anxiety
timeFrame: 10 weeks
measure: depression
timeFrame: 10 weeks
measure: skin health
timeFrame: 10 weeks
measure: vulvovaginal health
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University MedStar Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT03606707: Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
Official title: Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain, Head
Sleep Disturbance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Exclusion criteria Coagulopathy, allergy to contrast material, pregnancy Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Detailed description: Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint on sleep quality and head and neck pain in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration

Exclusion Criteria:

* Coagulopathy, allergy to contrast material, pregnancy

Primary outcomes:
measure: neck pain
timeFrame: 3 months
Secondary outcomes:
measure: neck disability
timeFrame: 3 months
measure: sleep quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Manal Hassanien
state: Assuit
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
affiliation: Assiut University
name: Manal Hassanien, MD
role: PRINCIPAL_INVESTIGATOR
References: