louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04083742: The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
Official title: The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narrow Angle
Open Angle
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 59
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eyes with narrow angle and eyes with open angle

Brief summary: This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION


Eligibility criteria: Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With at least one of following eye status for the corresponding eye population:

A. Eye with Open Angle (defined by Spaeth gonioscopy grading)

B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 study
2. Active infection or inflammation in either eye
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place
6. Soft lenses worn within one hour prior to study device acquisitions

Primary outcomes:
measure: Repeatability and Reproducibility 1
timeFrame: 1 day
measure: Repeatability and Reproducibility 2
timeFrame: 1 day
measure: Repeatability and Reproducibility 3
timeFrame: 1 day
measure: Repeatability and Reproducibility 4
timeFrame: 1 day
measure: Repeatability and Reproducibility 5
timeFrame: 1 day
measure: Repeatability and Reproducibility 6
timeFrame: 1 day
measure: Agreement 1
timeFrame: 1 day
measure: Agreement 2
timeFrame: 1 day
measure: Agreement 3
timeFrame: 1 day
measure: Agreement 4
timeFrame: 1 day
measure: Agreement 5
timeFrame: 1 day
measure: Agreement 6
timeFrame: 1 day
Secondary outcomes:
measure: Adverse Events Rate
timeFrame: 1 day
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Mitchell Dul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04367142: Rapid Detection of COVID-19 by Portable and Connected Biosensor
Official title: Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2

Brief summary: The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.


Eligibility criteria: Inclusion Criteria:

* Male or female or child without age limit
* Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
* Patient to be diagnosed using a PCR test on nasopharyngeal swab.
* Social insured

Exclusion Criteria:

* Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
* Patient refusal to participate

Primary outcomes:
measure: Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team
timeFrame: Baseline (at admission)
Secondary outcomes:
measure: Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admission
timeFrame: Baseline (at admission)
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Enagnon Kazali ALIDJINOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04256642: Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia
Official title: Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cesarean Section Complications
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Thammasat University
First posted: 2020-02-05
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing scheduled Cesarean delivery

Exclusion Criteria:

* Patients with an ASA score greater than 3
* Allergies to study medications
* Contraindications to neuraxial analgesia
* Patients with chronic pain
* Patients unable to communicate in the study language

Primary outcomes:
measure: 24 hour area under the curve pain scores
timeFrame: First 24 hour
Secondary outcomes:
measure: Measurement of quality of recovery after cesarean delivery
timeFrame: First 24 hours
measure: Nausea and vomiting
timeFrame: First 24 hours
measure: Analgesic usage
timeFrame: First 24 hours
measure: Pruritus
timeFrame: First 24 hours
measure: Incidente of persistent surgical pain
timeFrame: Three months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Albert Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02463942: Tick-borne Encephalitis and Positive Borrelial Antibodies
Official title: Management of Patients With Tick-borne Encephalitis and Positive Anti-Lyme Borreliae Antibody Results
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tick-borne Encephalitis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2015-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis.

Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* clinical picture compatible with tick-borne encephalitis,
* clear cerebrospinal fluid,
* cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L,
* positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,
* positive serum IgG antibodies against Lyme borreliae.

Exclusion Criteria:

* isolation of B.burgdorferi sensu lato from cerebrospinal fluid,
* positive intrathecal borrelial antibody production index,
* seroconversion of borrelial IgG antibodies,
* presence of erythema migrans and/or borrelial lymphocytoma in the last month,
* Bannwarth syndrome.

Primary outcomes:
measure: Objective manifestations of Lyme borreliosis
timeFrame: one year
measure: Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
References:
Clinical trial NCT00665106: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Official title: A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
Diabetes
Diabetic retinopathy
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy


Eligibility criteria: Inclusion Criteria:

* M \& F 18 years and older
* Diagnosed with diabetes mellitus and presenting diabetic retinopathy

Exclusion Criteria:

* Monocular
* History of current ocular hypertension or glaucoma in either eye defined
* Any significant ocular disease (other than diabetic retinopathy)

Primary outcomes:
measure: Ocular safety
timeFrame: Over one year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
Study officials:
References:
Clinical trial NCT02754206: Cerebral Blood Flow Regulation and Concussions
Official title: Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Concussion
Post-Concussion Syndrome
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collegiate Athletes who are currently playing a contact-collision sport.

Brief summary: The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

Detailed description: Comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. For those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.

Eligibility criteria: Inclusion Criteria:

* Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.

Exclusion Criteria:

* Participants who are unable to play as a result of injury. Presence of irregular heart beat.

Primary outcomes:
measure: Cerebral blood flow regulation
timeFrame: Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion
Secondary outcomes:
measure: Blood Biomarkers
timeFrame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
measure: Memory Function Test
timeFrame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
measure: Balance Test
timeFrame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
measure: Orthostatic Tolerance Test
timeFrame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
measure: Cerebral Vasoreactivity
timeFrame: Control, 3 days post concussion, 21 days post concussion, 3 months post concussion
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Sushmita Purkayastha, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purkayastha S, Adair H, Woodruff A, Ryan LJ, Williams B, James E, Bell KR. Balance Testing Following Concussion: Postural Sway versus Complexity Index. PM R. 2019 Nov;11(11):1184-1192. doi: 10.1002/pmrj.12129. Epub 2019 Apr 3.
Clinical trial NCT04401306: Remote Training in Laparoscopy
Official title: Remote Training in Laparoscopy: A Randomized Trial Comparing Home-based Self-regulated Training to Centralized Instructor-regulated Training.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Surgery
Keywords: Education
Simulation
Surgery
Transfer
Self-regulated learning
Gynecology
Urology
Laparoscopy
Home
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: North Denmark Region
name: KARL STORZ Endoscopy Denmark
First posted: 2020-05-26
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.


Eligibility criteria: Inclusion Criteria:

* Participant is a medical doctor
* Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Performed \> 50 lap procedures prior to enrollment
* participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark

Primary outcomes:
measure: Mean time for laparoscopic skills test (LASTT).
timeFrame: 0-7 months
Secondary outcomes:
measure: Test-score SUTT
timeFrame: 1-7 months
measure: Training time
timeFrame: 6-8 weeks
measure: Training distribution
timeFrame: 6-8 weeks
measure: Pass-rates
timeFrame: 6-8 weeks
Other outcomes:
measure: Interview
timeFrame: 0-3 months
Locations:
city: Aarhus
country: Denmark
facility: Centre for Health Sciences Education, Aarhus University
state: Danmark
Study officials:
affiliation: Centre for Health Sciences Education, Aarhus University, Denmark
name: Sigurd B Sloth, MD, PhD fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06526806: The Effect of Use of Kahoot in Pediatric Emergency Nursing Course on Students' Course Success and Motivation Levels
Official title: The Effect of Use of Kahoot in Pediatric Emergency Nursing Course on Students' Course Success and Motivation Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Nurse's Role
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: OTHER

Brief summary: With the characteristics of the new generation and the innovations brought by the age, it has become inevitable to use new educational, instructive and entertaining methods in nursing education. Considering the problems experienced by nursing students with traditional education, the use of Kahoot will be a remarkable result in the literature. The gamification process with Kahoot encourages thinking skills in situations where the subject is sensitive and challenging, ensuring better retention of information and improving internal motivation. Therefore, in order to make learning efficient and to ensure the active participation of students, it should be processed using different interactive methods in nursing education. Pediatric emergency nursing course is a content-intensive and rich course that blends emergency and pediatric nursing, containing information on child health and development in addition to the learning outcomes of the emergency nursing course. This study was carried out within the scope of the pediatric emergency nursing course; It is thought that it will enable students to repeat the basic concepts of the course, master the terminology, and provide a supportive learning environment for pediatric emergency nursing, which is a difficult field for students, and will contribute to nursing education and nursing literature.

Detailed description: This study was planned as a randomized controlled study to determine the effect of using Kahoot in the pediatric emergency nursing course on students' course success and motivation levels.

Eligibility criteria: Inclusion Criteria:

* Those over 18 years of age,
* Third year nursing students,
* Taking the pediatric emergency nursing course for the first time,
* Those who have not experienced Kahoot before,
* Nursing students who volunteer to participate in the research will be included in the research.

Exclusion Criteria:

* Those who do not volunteer to participate in the research

Primary outcomes:
measure: Exam score
timeFrame: Five months
measure: Motivation Scale for Instructional Material mean scores
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Asli Kudubeş
Study officials:
affiliation: BİLECİK ŞEYH EDEBALİ UNIVERSITY
name: ASLI KUDUBEŞ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363906: A Study of Dulaglutide in Healthy Participants
Official title: Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe.

This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU).


Eligibility criteria: Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination at time of screening
* Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

* Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related compounds, or any components of the formulation
* Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide
timeFrame: Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28
measure: PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide
timeFrame: Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas
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 NCT06533306: Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
Official title: Estimation of the Risk of Presenting Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptorchidism
Keywords: Cryptorchidism
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 126
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously operated on for cryptorchidism

Brief summary: The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.


Eligibility criteria: Inclusion Criteria:

* Patients aged 13 years or older, previously operated on for cryptorchidism.

Exclusion Criteria:

* Diagnosis of endocrine disease or any polymalformative syndrome.
* Synchronous bilateral cryptorchidism.

Primary outcomes:
measure: Contralateral Cryptorchidism
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vilafranca Del Penedès
country: Spain
facility: Consorci Sanitari Alt Penedès-Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Carme Grande Moreillo, MD
role: PRINCIPAL_INVESTIGATOR
References: