louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03486717: The Use of Virtual Reality Goggles
Official title: The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.

Detailed description: All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not.

At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.

Eligibility criteria: Inclusion Criteria:

* Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry

Exclusion Criteria:

* History of dental anxiety

Primary outcomes:
measure: Self-reported patient perception of pain
timeFrame: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
measure: Behavior of child
timeFrame: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Casey Goetz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528017: Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2
Official title: Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Keywords: Daily disposable contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Clariti 1-Day contact lenses.

Detailed description: Subjects are expected to attend 3 study visits and wear the PRECISION1 and Clariti 1-Day study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Eligibility criteria: Key Inclusion Criteria

* Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
* Successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of PRECISION1, Clariti 1-Day, or DAILIES TOTAL1 contact lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) With Study Lenses
timeFrame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Medina
country: United States
facility: Alcon Investigator 6402
state: Minnesota
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Wichita Falls
country: United States
facility: Alcon Investigator 8028
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02327117: Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty, Total
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.


Eligibility criteria: Inclusion Criteria:

* Individuals with osteoarthritis who indicated for primary TKA.

Exclusion Criteria:

* Previous history of ceberovascular diseases
* Previous history of myocardial infarction
* Candidates for bilateral TKA

Primary outcomes:
measure: Hb Level 48 Hours After Total Knee Arthroplasty
timeFrame: 48 hours after TKA
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Amin Nemati
Study officials:
References:
Clinical trial NCT04387617: A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Official title: Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Stone
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution.
* Age 18-75 years of age.
* Patients of either gender.
* Patients of all ethnic backgrounds.
* Capable of giving informed consent.
* Capable and willing to fulfill the requirements of the study.

Exclusion Criteria:

* History of chronic pain.
* Chronic use of opioid or other pain medication (\> 12 weeks).
* Known allergy to CBD oil or other cannabinoids.
* Known or suspected pregnancy.
* Inability to give informed consent or unable to meet requirements of the study for any reason.
* Bilateral ureteroscopy.
* Current marijuana, cannabidiol (CBD), or dronabinol use.
* Liver disease/cirrhosis.
* Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.

Primary outcomes:
measure: Maximum Pain Intensity Score
timeFrame: postoperative Day 3
Secondary outcomes:
measure: Postoperative Rescue Narcotic Use
timeFrame: postoperative Day 3
measure: Total Urinary Symptoms Score
timeFrame: postoperative day 1 and postoperative day 3
measure: The Number of Subjects With Adverse Events
timeFrame: 3 days post-ureteroscopy
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Karen Stern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04088617: The Effects of Exogenous Ketones on Glucose Tolerance
Official title: The Effects of Exogenous Ketones on Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dietary Supplement: Ketone Supplement
Dietary Supplement: Placebo
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: BASIC_SCIENCE

Brief summary: The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Young healthy individuals
* Not taking any medications affecting glucose metabolism

Exclusion Criteria:

* Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
* Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
* Are currently using medications that may interfere with insulin sensitivity
* Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
* Are currently using ketone supplements
* Unable to travel to and from the university in order to make your testing appointments.
* Unable to follow the controlled diet instructions required for the study.
* If pregnant or are planning to become pregnant during the study (if female)

Primary outcomes:
measure: Glucose area under the curve
timeFrame: 2-hour
Secondary outcomes:
measure: Insulin area under the curve
timeFrame: 2-hour
measure: Free fatty acids area under the curve
timeFrame: 2-hour
measure: Glucose incremental area under the curve
timeFrame: 2-hour
measure: Insulin incremental area under the curve
timeFrame: 2-hour
measure: 2-hr glucose level
timeFrame: 2-hour
measure: Beta-hydroxybutyrate level
timeFrame: 2-hour
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan
state: British Columbia
Study officials:
References:
Clinical trial NCT05835817: Magnetoencephalography by Optical Pumping Magnetometer
Official title: Magnetoencephalography by Optical Pumping Magnetometer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnetoencephalography
Optical Pump Magnetometer
Neonate
Premature
Keywords: Magnetoencephalography
optical pump magnetometer
neonate
Premature
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling.

The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.


Eligibility criteria: Inclusion Criteria:

* For healthy adult volunteers
* Age between 18 and 65
* No pathology, no treatment
* No toxicant intake
* For term newborns
* Child between 38 and 42 weeks gestational age on the day of registration
* No pathology, no treatment
* For children born prematurely
* Child between 28 and 36 weeks gestational age on the day of registration
* No pathology, no treatment apart from routine care related to prematurity
* For pregnant women
* Pregnant with between 28 to 40 weeks gestational age on the day of registration
* No pathology, no treatment

Exclusion Criteria:

* Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible.
* Patients who cannot stand to stand still for a few minutes.
* Newborn on ventilatory assistance or infusion
* Newborn baby not meeting the age criteria

Primary outcomes:
measure: Signal to noise ratio of the MEG OPM
timeFrame: 1 day
measure: Signal to noise ratio of HR EEG
timeFrame: 1 day
measure: Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02181517: A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of wet age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Hypersensitivity, allergy, or anaphylactic reaction to iodine
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
timeFrame: Baseline, Week 20
measure: Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
timeFrame: Baseline, Week 20
measure: Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
timeFrame: Baseline, Week 20
measure: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 16, Week 20
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04216017: Glenohumeral Cortisone Injection
Official title: A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Humeral Fractures
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-01-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Detailed description: THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.

Eligibility criteria: Inclusion Criteria:

1.18-90

2. Proximal Humerus Fracture

3. Decreased range of motion at 6 wk follow-up

4. Likely to be available for follow up for 26 wks

Exclusion Criteria:

1. Known drug allergy to kenalog or lidocaine
2. Unable to complete functional outcome
3. Pregnant Women

Primary outcomes:
measure: American Shoulder Elbow Society Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jonah Hebert-Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547417: To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Men of Various Populations With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 1933
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.


Eligibility criteria: Inclusion Criteria:

* At least 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Other primary sexual disorders
* History of penile implant or clinically significant penile deformity
* History or current nitrate use
* History of certain heart problems
* History of certain kidney problems

Primary outcomes:
measure: Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile
timeFrame: 12 weeks
measure: Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05761717: Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation
Official title: Clinical Study of mRNA Personalized Tumor Vaccine Encoding Neonatal Antigen Combined With Sintilimab Injection Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posto Perative Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 12\~18 participants in Cohort . C1:50 ug of PCV; C2: 100 ug of PCV ; C3: 150 ug of PCV.Extended research phase:49 participants in Cohort.
Primary purpose: TREATMENT

Brief summary: This is an open, one-arm study to evaluate the safety and efficacy of mRNA personalized tumor vaccine (tumor vaccine) encoding neonatal antigen in combination with Sintilimab injection for adjuvant prevention of postoperative recurrence of hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Are ≥18 years old (including boundary values), without limitation of sex at time of consent.
* The patient was confirmed as hepatocellular carcinoma by histopathology or cytology after surgery, and the lesion was completely resected by surgery R0 (no residual tumor under postoperative microscope and naked eye), and no residual lesion or extrahepatic metastasis was confirmed by postoperative imaging (CT/MRI).
* The patient is at high risk of postoperative recurrence, and the tumor must meet the following characteristics: Patients with hepatocellular carcinoma IIb/IIIa as defined by the 2019 Chinese Staging System.
* The Eastern Oncology Consortium Physical State Score (ECOG PS) is 0 or 1, and the Child-Pugh rating is A

Exclusion Criteria:

* Known allergy to any tumor vaccine, adjuvant, Stintilimab Injection formulation, fluorouracil inj, oxaliplatin injcalcies;
* Tumor mutation load (TMB) was less than 2.0/Mb or neonatal antigen load (TNB) was less than 0.5/Mb or the predicted number of neonatal antigens was less than 15;

Primary outcomes:
measure: One-year recurrence-free survival rate (RFS);
timeFrame: 1 year
measure: Overall survival (OS) after initial administration.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: