louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01339507: A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft
Official title: A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Conjunctivitis
Lead sponsor: Cunningham, Derek N., O.D., P.A.
Sponsor class: INDIV
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-04-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with allergic conjunctivitis and who meet all other inclusion/exclusion criteria will be eligible to enter the study.

Brief summary: The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Detailed description: After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Eligibility criteria: Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
2. Have allergic ocular symptoms within the last three days.
3. Are willing/able to follow instructions from the study investigator and his/her staff.
4. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Have known hypersensitivity to either BEPREVE™ or LASTACAFT® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
2. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
3. Are pregnant or nursing/lactating.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Derek Cunningham
state: Texas
Study officials:
affiliation: Dell Laser Consultants
name: Derek Cunningham, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982107: Quality of Vision in Implantable Collamer Lens (ICL)
Official title: Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupil Diameter
Keywords: ICL
QoV
Visual acuity
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomly choosen patients from the hospital records who had ICL surgery at He Eye Hospital, Shenyang, China during September 2019 to September 2020. They must have signed informed consent for their records to be used for education and research purposes before undergoing ICL surgery for myopic correction.

Brief summary: The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.

Detailed description: The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.

Eligibility criteria: Inclusion Criteria:

* Myopic eyes
* Preoperative corneal endothelial cell count ≥2200/mm2
* Preoperative central anterior chamber depth\> 2.80mm
* Intraocular pressure within the normal range (10-21mmHg)

Exclusion Criteria:

* Severe dry eye
* Cataract and glaucoma
* Patients with uveitis
* Retinal detachment
* Patients with autoimmune diseases
* Patients with systemic diseases such as diabetes and hypertension
* Patients with mental or cognitive abnormalities

Primary outcomes:
measure: Subjective Quality of vision
timeFrame: Baseline (before surgery) and 3 month after surgery
measure: Pupil diameter pre-operation and post-operation
timeFrame: Baseline (before surgery) and 3 month after surgery
measure: Wave front aberrometry
timeFrame: baseline and 3 month after surgery
measure: Point Spread Function (PSF)
timeFrame: baseline and 3 month after surgery
measure: Strehl ratio
timeFrame: Baseline and 3 month after surgery
measure: Modulation transfer function (MTF)
timeFrame: Baseline and 3 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Specialist Hospital, Shenyang.
state: Liaoning
Study officials:
affiliation: He Eye Specialist Hospital, Shenyang.
name: Wei He
role: STUDY_CHAIR
References:
Clinical trial NCT05096507: Cytokines, POD, Health Status, Older Hip Fracture
Official title: Perioperative Cytokines, Postoperative Delirium and Health Status in Older People Undergoing Hip Fracture Surgery - a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Hip Fracture Surgery
Older People
Keywords: Postoperative delirium
Older people
Cytokines
Self-reported Health Status
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age ≥ 65 years old presenting to hospital with a primary hip fracture

Brief summary: An investigation of the change in inflammation marker levels across hip fracture surgery and an exploration of any association with change in self reported health status and incidence of postoperative delirium


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years old
* Admitted for primary hip fracture surgery

Exclusion Criteria:

* Preoperative cognitive impairment
* History of neurosurgery, neurologic diseases or head trauma
* Current systemic bacterial or viral infection
* Complex or multiple injuries

Primary outcomes:
measure: Cytokine dynamics
timeFrame: 2 days
measure: Incidence of postoperative delirium
timeFrame: 5 days
Secondary outcomes:
measure: Self reported health related quality of Life
timeFrame: 120 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
affiliation: University of Nottingham
name: Iain Moppett, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01485107: Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity of the décolleté
Keywords: Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Detailed description: This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Female, aged 35 to 60 years.
* Subject in good health.
* Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Breast size \>400cc each as measured by water displacement method.
* History of breast reduction surgery.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertropic scarring

Primary outcomes:
measure: Improvement in overall lifting and tightening of skin
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Skin Laxity of the Décolleté
timeFrame: 90 and 180 days post-treatment
measure: Bilateral chest measurements
timeFrame: 90 and 180 days post-treatment
measure: Overall aesthetic improvement
timeFrame: 90 and 180 days post-treatment
measure: Patient satisfaction
timeFrame: 90 and 180 days post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
state: California
Study officials:
affiliation: Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
name: Michael Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02183207: PEG by Introducer Method Via EG Scan
Official title: Percutaneous Endoscopic Gastrostomy by Introducer Method Via Visualization Through E.G. ScanTM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Aspiration
Esophageal Stenosis
Keywords: percutaneous endoscopic gastrostomy
Introducer method
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: IntroMedic Co., Ltd.
First posted: 2014-07-08
Enrollment: 24
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
Primary purpose: TREATMENT

Brief summary: Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.


Eligibility criteria: Inclusion Criteria:

* Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month

Exclusion Criteria:

* Patients with esophageal ulcers or strictures
* Patients with prior esophageal/gastric surgery (excepting gastric wedge resection)
* Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation
* Other patients in whom the study investigators consider unfit for inclusion

Primary outcomes:
measure: The success rate of PEG via introducer method by visualization through EG ScanTM
timeFrame: up to 1 year from PEG insertion
Secondary outcomes:
measure: Complication rate
timeFrame: up to one year from PEG insertion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
Study officials:
References:
citation: Dormann AJ, Wejda B, Kahl S, Huchzermeyer H, Ebert MP, Malfertheiner P. Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy. Am J Gastroenterol. 2006 Jun;101(6):1229-34. doi: 10.1111/j.1572-0241.2006.00541.x.
citation: Yuki M, Amano Y, Komazawa Y, Fukuhara H, Shizuku T, Yamamoto S, Kinoshita Y. Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients. World J Gastroenterol. 2009 Nov 28;15(44):5586-91. doi: 10.3748/wjg.15.5586.
Clinical trial NCT02561507: Perioperative Aspirin Usage Survey
Official title: Use of Aspirin in the Perioperative Setting: A Surgeon's Survey
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgery
Cardiovascular Disease
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2015-09-28
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: Members of the American College of Surgeons

Brief summary: This is a survey of members of the American College of Surgeons (ACS), to describe and explore current patterns of their decisions about withholding or continuation for patients taking aspirin (ASA) in the perioperative period. Secondarily, the survey will also explore surgeons' knowledge about the risks and benefits attending this decision, and about national organizations' recommendations.

Detailed description: An announcement of the survey and invitation to participate will be posted in the "ACS Surgery News" newsletter published by the American College of Surgeons. Surgeons of all specialties will be invited to participate. No identifiers will be maintained with survey responses. In addition to the substantive questions below, typical demographic data will be obtained including participants' duration of practice, specialty, gender, state, etc.

The survey will include questions intended to characterize current practice surrounding the decision to continue or withhold aspirin in the perioperative period. Other questions will focus on surgeons' knowledge of national medical/surgical organizations that have published guidelines on the perioperative use of aspirin. Finally, other survey questions will characterize surgeons' knowledge of the platelet rebound effect.

Eligibility criteria: Inclusion Criteria:

* Members of the American College of Surgeons

Exclusion Criteria:

* None

Primary outcomes:
measure: Typical proportion of participants' patients given a recommendation to stop taking aspirin
timeFrame: At time of survey; generally less than 20 minutes
measure: Proportion of participants correctly identifying national organizations with perioperative aspirin recommendations
timeFrame: At time of survey; generally less than 20 minutes
measure: Proportion of participants correctly answering questions about platelet rebound effect
timeFrame: At time of survey; generally less than 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Neal Gerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854307: The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Official title: The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumoperitoneum
Keywords: Difference of
measurements
before and after
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Perioperative goal directed fluid therapy may reduce complication rate after surgery. Minimal invasive cardiac output monitoring is a key method to guide fluid therapy. More operations are being performed by keyhole surgery (laparoscopy). For laparoscopy, the abdomen is filled with carbon dioxide. Increased pressure in the abdomen may influence minimal cardiac output monitoring, therefore minimal cardiac output monitoring is not recommended during laparoscopy. This study aims to validate minimal cardiac output monitoring during laparoscopy and therefore facilitate for goal directed fluid therapy.


Eligibility criteria: Inclusion Criteria:

* all patients \>18 years scheduled for robot-assisted prostatectomy
* able to give informed consent

Exclusion Criteria:

* Patient with atrial fibrillation or other non-regular rhythm.
* Severe aorta/mitral stenosis
* Not able to give informed consent

Primary outcomes:
measure: Change of stroke volume variation and pulse pressure variation during pneumoperitoneum
timeFrame: peroperative
Secondary outcomes:
measure: Difference in measurements from different methods of minimal cardiac output monitoring.
timeFrame: peroperative
measure: Effect of fluid bolus under pneumoperitoneum (responder vs. non-responder)
timeFrame: peroperative
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
Clinical trial NCT00265707: Evaluation of a New Blood Pressure Measuring Device.
Official title: A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Hypotension
Lead sponsor: Maaynei Hayesha Medical Center
Sponsor class: OTHER
First posted: 2005-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
* Up to 100 subjects with various levels of blood pressure values will be tested.

Detailed description: The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

* Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
* Each measurement will be performed simultaneously by two examiners specially trained.
* Informed consent will be obtained from all participants.
* The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or above
* Signed written informed consent

Exclusion Criteria:

* A history of cardiac arrythmia
* Wrist circumference smaller than 13cm or larger than 19.5cm
* Documented peripheral vascular disease
* Damage or injury to the left wrist
* Participation in any other clinical study
* Any acute coronary of cardiovascular illness

Primary outcomes:
measure: The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Medicine, Maaynei Hayesha Hospital
Study officials:
affiliation: Maaynei Hayesha Hospital
name: Mordchai Ravid, MD FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456507: Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
Official title: An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food effect
bioavailability
oxycodone
sequestered Naltrexone
management of moderate to severe pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Detailed description: Bioavailability

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant diseases

Primary outcomes:
measure: Area Under the Curve (AUC) to time infinity (inf) of oxycodone
timeFrame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone
timeFrame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of oxycodone
timeFrame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Secondary outcomes:
measure: C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.
timeFrame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit
timeFrame: predose, 1,2,4,8,12,24,48,120 hours post-dose
measure: Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.
timeFrame: over 120 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: