louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03638726: Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
Official title: Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Mydriasis
Adverse Drug Event
Keywords: intraoperative mydriasis
subconjunctival atropine
intracameral epinephrine
cataract surgery
Lead sponsor: Dar El Oyoun Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study
Primary purpose: OTHER

Brief summary: Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.

Detailed description: The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.

Eligibility criteria: Inclusion Criteria:

* Cases of bilateral visually significant cataract

Exclusion Criteria:

* Poor pupil dilation(less than 6 mm diameter).
* History of previous eye surgery or trauma
* History of use of eye drops affecting pupil size such as pilocarpine.
* Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
* Pediatric age group (less than 18 years old).
* Pupil abnormalities, such as anisocoria or neurological disorders.
* Associated glaucoma, uveitis, corneal, retinal or optic nerve disease.
* Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents).
* Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).

Primary outcomes:
measure: Intraoperative pupil diameter
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative complications
timeFrame: Starting from first postoperative day till one month.
measure: Postoperative corneal thickness
timeFrame: 1 month after surgery
measure: Postoperative corneal endothelial density
timeFrame: 1 month after surgery
measure: Postoperative pupil diameter
timeFrame: one day, one week and one month after surgery
measure: Postoperative visual acuity
timeFrame: One day, one week and one month after surgery
measure: Postoperative intraocular pressure (IOP)
timeFrame: One day, one week and one month after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dar El Oyoun Hospital
state: Giza
Study officials:
affiliation: Dar El Oyoun Hospital
name: Nossair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517426: Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Keywords: heart failure,
exercise
periodic breathing,
acetazolamide
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure.

Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.


Eligibility criteria: Inclusion Criteria:

* chronic heart failure in stable clinical condition
* exercise-induced periodic breathing

Exclusion Criteria:

* comorbidities
* NYHA class IV

Primary outcomes:
measure: Suppression of periodic breathing
timeFrame: two days
Secondary outcomes:
measure: suppression of sleeping apnea
timeFrame: two days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, University of Milan
Study officials:
affiliation: Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
Clinical trial NCT00733265: Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Official title: Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal Impairment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.


Eligibility criteria: Inclusion Criteria:

* Patients must have severe kidney disease
* Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
* All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion Criteria:

* Patients requiring dialysis
* History of allergy to aspirin or clopidogrel
* Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
* Recent history of fainting or light-headedness

Primary outcomes:
measure: Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
timeFrame: Scheduled times during the 3 days after the study drug is taken
Secondary outcomes:
measure: Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
timeFrame: Screening through completion of the study
measure: Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
timeFrame: Scheduled times during the 3 days after the study drug is taken
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
citation: Butler K, Teng R. Pharmacokinetics, pharmacodynamics, and safety of ticagrelor in volunteers with severe renal impairment. J Clin Pharmacol. 2012 Sep;52(9):1388-98. doi: 10.1177/0091270011415526. Epub 2011 Sep 29.
Clinical trial NCT01917565: The Use of Airtraq Laryngoscope Versus Macintosh Laryngoscope and Fiberoptic Bronchoscope by Experienced Anesthesiologists
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Hemodynamic Parameters
Intubation Times
Complications During and After Intubation
Keywords: airway management
laryngoscope
Airtraq
Macintosh laryngoscope
fiberoptic bronchoscope
intubation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing surgery under general anesthesia

Brief summary: The investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters.

Detailed description: The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.

The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.

Eligibility criteria: Inclusion Criteria:

* ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation

Exclusion Criteria:

* Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility

Primary outcomes:
measure: The required time to successful tracheal intubation
timeFrame: six months
Secondary outcomes:
measure: The first-attempt success rate of tracheal intubation
timeFrame: six months
Other outcomes:
measure: the effects of the tracheal intubation on hemodynamic parameters
timeFrame: six months
Locations:
city: Istanbul
country: Turkey
facility: Department of Anesthesiology, Marmara University School of Medicine
Study officials:
References:
Clinical trial NCT01924065: Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation
Official title: Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Cardioversion
Cerebrovascular Stroke
Keywords: Atrial fibrillation, conversion, stroke
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent instead of warfarin for 3 weeks.

If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.


Eligibility criteria: Inclusion Criteria:

* Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion

Exclusion Criteria:

* Urgent cardioversion
* Patients who have implanted pace-makers or other metal devices
* Claustrophobia
* Hematological disorders disabling patients to receive anticoagulant agents
* Atrial fibrillation secondary to temporary causes.
* Serious rheumatic heart valve disease
* Hyperthyroidism
* History of malignancy
* Left atrium diameter \> 55 mm
* Ejection fraction \< 0.25

Primary outcomes:
measure: Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
timeFrame: 2 years
measure: Efficacy Clinical End-point
timeFrame: 2 years
measure: Ischemic Stroke/Transient Ischemic Attack
timeFrame: 2 years
measure: Acute Ischemia in MRI
timeFrame: 1 week
measure: Mortality
timeFrame: 2 years
measure: Hemorrhagic Stroke
timeFrame: 2 years
measure: Gastrointestinal Bleeding
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Mediterranean Region
Study officials:
affiliation: Suleyman Demirel University
name: Mehmet Ozaydin, Professor,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02061865: Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Wet Age-related Macular Degeneration (AMD)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

Key Criteria:

Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD.

Exclusion Criteria:

1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor)
2. Active neovascular AMD in the fellow eye requiring treatment
3. Scar, fibrosis, or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.

Primary outcomes:
measure: Safety
timeFrame: day 1 through week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Boston
country: United States
state: Massachusetts
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT01388465: Text-message Support to Improve Oral Antibiotic Adherence After ED Discharge
Official title: Feasibility of Using Text-Message Support to Improve Antibiotic Adherence After ED Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: Adherence
Intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are testing the hypothesis that patients who are exposed to daily text-message (TM) assessments with feedback will have better adherence to prescription than those patients not exposed to TM-based queries with feedback.

Detailed description: Short course, oral antibiotics are frequently prescribed to patients treated/discharged from the Emergency Department. Medication adherence involves the patient taking the proper daily dosing of prescribed medication for the entire length of time it is prescribed. Previous studies have shown that prescription non-filling rates range from 5 to 20%. Other studies have shown that even if patients fill their prescription, as low as 30-40% will properly take the medication. The purpose of this study is to determine if the proportion of patients discharged from the Emergency Department that are adherent with antibiotics is higher in patients that are provided TM support using self-report.

Eligibility criteria: Inclusion Criteria:

* Ages 18 and older
* Planned discharge form the ED on oral antibiotics

Exclusion Criteria:

* non-English speaking
* Prisoner
* No personal mobile phone with text message features

Primary outcomes:
measure: Successfully picked up prescription within 24 hours of ED discharge
timeFrame: 24 hours post ED discharge
Secondary outcomes:
measure: Complete adherence to oral antibiotics
timeFrame: 3-14 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Mercy Emergency Department
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00803166: Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams
Official title: Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioequivalence
Halobetasol Propionate
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
timeFrame: Over the course of three days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05106465: A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and Magnetic Resonance Imaging (MRI) Measures of Brain Tissue Damage
Official title: Konect-MF: A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and MRI Measures of Brain Tissue Damage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis (MS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 200
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: The study population includes participants with a diagnosis of MS who are enrolled in MS PATHS.

Brief summary: The purpose of the study is to explore association patterns between digital outcome assessments from Konectom and MRI measures of brain tissue damage.


Eligibility criteria: Inclusion Criteria:

* Should be enrolled in multiple sclerosis partners advancing technology and health solutions (MS PATHS).
* Participant (or participant's legal representative) has the ability to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
* Should have literacy of written language in which the software and Instructions for use are displayed (User Interface \[UI\], Instructions).

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
* Inability to use a smartphone as per physician's opinion.
* Not owning a Konectom-compatible smartphone.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage
timeFrame: Up to 1 year
Secondary outcomes:
measure: Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Fluid-attenuated Inversion Recovery (FLAIR) Hyperintense MS Lesions Using 3D-T1 and 3D FLAIR Data
timeFrame: Up to 1 year
measure: Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data
timeFrame: Up to 1 year
measure: Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data
timeFrame: Up to 1 year
measure: Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Multiple Sclerosis Centre
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: