louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00437593: UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue
Official title: UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Diseases
Keywords: preretinal membrane
vitrectomy
uhr-oct
hd-oct
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

Detailed description: Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)

Main outcome measures are:

UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.

Eligibility criteria: Inclusion Criteria:

* Preretinal membrane
* Age between 18 and 85 years
* Combined surgery possible(phacoemulsification and vitreoretinal procedure)

Exclusion Criteria:

* Age-related macular degeneration
* Previous retinal detachment surgery
* Previous laser treatment

Primary outcomes:
measure: UHR-OCT HD-OCT
timeFrame: 12 months
measure: Distance Visual acuity
timeFrame: 12 months
measure: Near Visual acuity
timeFrame: 12 months
measure: Contrast sensitivtiy
timeFrame: 12 months
Secondary outcomes:
measure: OCT Stratus 3000
timeFrame: 12 months
measure: Visual Field
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolf Foundation Clinic
Study officials:
affiliation: Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery
name: Susanne Binder, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01048593: Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
Official title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Inflammatory Reaction Due to Ocular Lens Prosthesis
Keywords: ocular inflammation cataract surgery
post cataract surgery inflammation
Lead sponsor: ICON Bioscience Inc
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.

Detailed description: All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.

Eligibility criteria: Inclusion Criteria:

* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

* Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
* Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
* Patients with any signs of intraocular inflammation in either eye at screening.
* Patients who have received any prior intravitreal injections in the study eye.

Primary outcomes:
measure: Clearance of Anterior Chamber Cells
timeFrame: Day 8 post treatment
Secondary outcomes:
measure: Anterior Chamber Flare (ACF) Grade
timeFrame: Day 90 post-treatment
measure: Conjunctival Erythema Grade
timeFrame: Day 90 post-treatment
measure: Corneal Edema Grade
timeFrame: Day 90 post-treatment
measure: Anterior Chamber Cell Grade
timeFrame: Day 90 post-treatment
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
Study officials:
affiliation: Altos Eye Physicians
name: David Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584293: DIABASE; Diabetes Mellitus Registry in Second Care
Official title: DIABASE; Diabetes Mellitus Registry in Second Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Ziekenhuisgroep Twente
Sponsor class: OTHER
Collaborators: name: University of Twente
First posted: 2022-10-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients with type 1 or type 2 diabetes mellitus.

Patients are recruited at the outpatient clinic of internal medicine, diabetes clinic.

Brief summary: This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Patients aged 18 years or older
* Patients visiting the outpatient clinic internal medicine in the ZGT Hospital
* Written informed consent

Exclusion Criteria:

* Severe general diseases or mental disorders making the participation in the study impossible

Primary outcomes:
measure: Real world data from medical devices and clinical outcome in a registry
timeFrame: 0-30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
state: Overijssel
Study officials:
References:
Clinical trial NCT03843593: A Study To See Why Patients Agree To or Decline To Have Treatment After Surgery
Official title: Why Do Patients Agree To or Decline Adjuvant Immunotherapy and Are They Satisfied With Their Decision?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Melanoma
Keywords: Decline Adjuvant Immunotherapy
Agree To Adjuvant Immunotherapy
Nivolumab
Pembrolizumab
19-012
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 38
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: Potential research participants will be identified by members of the Melanoma service, the patients" treatment team, or the PI.

Brief summary: The purpose of this study is to find out what patients consider when deciding whether or not to receive adjuvant treatment, and how patients feel about their decision after one year.


Eligibility criteria: Inclusion Criteria:

* Patients with stage IIIB, IIIC, IIID, or IV (AJCC, 8th edition) cutaneous melanoma rendered free of disease by surgical resection.
* Patients are being offered adjuvant nivolumab or pembrolizumab therapy
* Patient has not yet formally discussed their treatment options with their Medical Oncologist.
* Age 18 or older.
* Ability to speak and read English because we do not have the resources to translate materials into other languages.

Exclusion Criteria:

* Patient not currently free of disease.
* Candidate for adjuvant dabrafenib/trametinib therapy.
* Patients who have received prior checkpoint inhibitor therapy.

Primary outcomes:
measure: self-reported factors patients consider in deciding whether or not to undergo adjuvant therapy
timeFrame: 1 year
Secondary outcomes:
measure: self-reported quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Chapman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03058393: Analyzing Challenging Clinical Discussions in Orthopaedics
Official title: Effectiveness of Teach-back in Orthopedic Treatment Decision Discussions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Teach-Back Communication
Arthritis
Knee Osteoarthritis
Knee Arthropathy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to analyze patient:provider communication surrounding the discussion of difficult clinical conversations such as knee replacement options. This study will also examine how using the teach-back communication technique can improve communication between patients and providers. Orthopedic residents, fellows, physician assistants, and attendings that agree to participate will be consented. Patients, who are likely to engage in a difficult clinical conversation, such as those who have a clinical indication for a Total Knee Replacement or a Partial Knee Replacement, will be recruited from participating providers clinical schedules. Patient:provider interactions will be recorded and then the providers will attend a 1 hour education lecture about how to use teach-back. After attending the lecture, additional patient:provider interactions will be recorded and analyzed via a qualitative approach. Additionally, providers will participate in a semi-structured interview to capture their perceptions of teach-back and what challenges and benefits they may derive from using it.


Eligibility criteria: Inclusion Criteria (Patient Participants):

* Age 18 years and older
* Clinical indication for multiple treatment options

Exclusion Criteria (Patient Participants):

* Non-English speaking
* Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit

Inclusion Criteria (Provider Participants)

* Age 18 years and older
* A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery

Exclusion criterion (Provider Participants):

• Non-English speaking

Primary outcomes:
measure: Provider's uninterrupted utterances
timeFrame: End of discussion with patient, 20 minutes
measure: Patient/provider talking ratio
timeFrame: End of discussion with patient, 20 minutes
Secondary outcomes:
measure: Providers perceptions about teach-back
timeFrame: End of semi-structured interview, one hour
measure: Providers belief of future use of teach-back
timeFrame: End of semi-structured interview, one hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard C Mather III, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327193: Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
Official title: The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis, Postoperative Pulmonary
Keywords: Driving pressure
Positive end-expiratory pressure
Lung ultrasound
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 66
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: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV or more
* Severe cardiovascular disease
* Severe chronic obstructive pulmonary disease, emphysema
* History of pneumothorax, bullae
* History of lung resection surgery
* Conversion to laparotomy
* Refusal to participate

Primary outcomes:
measure: Modified lung ultrasound score
timeFrame: 30 minutes after PACU administration
Secondary outcomes:
measure: Modified lung ultrasound score
timeFrame: Intraoperative (at the end of operation before emergence)
measure: Incidence of intraoperative desaturation
timeFrame: Intraoperative
measure: Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
timeFrame: Intraoperative (30 minutes after designated PEEP applied)
measure: Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
timeFrame: 30 minutes after PACU administration
measure: Postoperative pulmonary complications
timeFrame: After operation~ postoperative day 3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongnogu
Study officials:
affiliation: Seoul National University Hospital
name: Susie Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147093: CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia Correction
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 41
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.


Eligibility criteria: Inclusion Criteria:

1. Age 45 years or more
2. Spectacle or soft contact lens wearer
3. Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
4. Best spectacle corrected visual acuity of 6/9 or better in each eye
5. Willingness to adhere to the instructions set forth in the clinical protocol
6. Signature of the subject Informed Consent form after review of Information to Participant document.

Exclusion Criteria:

1. Systemic or ocular allergies which might interfere with contact lens wear
2. Systemic disease which might interfere with contact lens wear
3. Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
4. Use of medication which might interfere with contact lens wear
5. Active ocular infection
6. Use of ocular medication
7. Significant ocular anomaly
8. Presence of two or more corneal scars in either eye
9. Monovision contact lens wearers
10. Pregnancy or lactation
11. Any medical condition that might be prejudicial to the study
12. Participants non-able to give consent or from a vulnerable group
13. Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
14. Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)

Primary outcomes:
measure: Distance LogMAR Visual Acuity
timeFrame: 7 days post wear
measure: Near LogMAR Visual Acuity
timeFrame: 7 days post wear
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
References:
Clinical trial NCT05062993: Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
Official title: Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: caudal epidural stimulation
chronic pain
lumbosacral radiculopathy
postlumbar surgery syndrome
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.


Eligibility criteria: Inclusion Criteria:

* chronic pain in legs or back pain
* unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections

Exclusion Criteria:

* coagulation disorders
* psychiatric disorders
* rheumatoid disorders
* infections

Primary outcomes:
measure: Numeric Rating Scale(NRS) (0-10)
timeFrame: before procedure
measure: Numeric Rating Scale
timeFrame: 2 weeks after procedure
measure: Numeric Rating Scale
timeFrame: 4 weeks after procedure
measure: Numeric Rating Scale
timeFrame: 8 weeks after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Selin Guven Kose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476293: Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
Official title: Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infiltration
Extravasation
IV Infiltration
IV Extravasation
Extravasation of Diagnostic and Therapeutic Materials
Keywords: Infiltration
Extravasation
Leaking
PIV Infiltration
IV Infiltration
Optical Detection of Infiltration
Optical Monitoring
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 139
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from Cincinnati Children's Hospital Medical Center.

Brief summary: The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.


Eligibility criteria: Inclusion Criteria:

* signed consent
* patient age under 12
* PIV with continuous fluids

Exclusion Criteria:

* no consent
* patient age over 12
* PIV fluids not continuous

Primary outcomes:
measure: Test performance of optical device for monitoring intravenous infusion site for infiltration.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Darcy Doellman, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Sylvia Rineair, MSHA, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Neil Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Michael Spigarelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893893: Very-low-density-lipoprotein Triglyceride (VLDL-TG) Uptake in Visceral Fat
Official title: Very-low-density-lipoprotein Triglyceride(VLDL-TG) Uptake in Visceral Fat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Obesity
Keywords: Obesity
Lipid metabolism
VLDL
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
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 volunteers

Brief summary: Purpose:

To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age: 20-50 years
* Premenopausal

Exclusion Criteria:

* Smoking
* Alcohol abuse
* Use of medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology M, Aarhus Hospital
Study officials:
References:
citation: Sondergaard E, Nellemann B, Sorensen LP, Gormsen LC, Christiansen JS, Ernst E, Dueholm M, Nielsen S. Similar VLDL-TG storage in visceral and subcutaneous fat in obese and lean women. Diabetes. 2011 Nov;60(11):2787-91. doi: 10.2337/db11-0604. Epub 2011 Sep 12.