louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06832046: Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital
Official title: Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Pain
Keywords: Pain Syndrome
Intranasal Fentanyl
pediatric
Pediatric surgical emergency
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child \< 18 years old who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.

Brief summary: Emergency trauma departments receive thousands of patients each year whose main symptom is pain. In recent years, intranasal fentanyl (FIN) has entered the therapeutic arsenal to treat pain in the emergency department. Various studies have validated its effectiveness for musculoskeletal pain as well as its tolerance and safety of use. Since then, new protocols have been implemented including this treatment. In This study, the investigators propose to retrospectively study the quality of prescription of intranasal fentanyl in the treatment of pain in the emergency department and the quality of monitoring of this treatment in current practice.


Eligibility criteria: Inclusion Criteria:

* Child \< 18 years old
* Child treated in the pediatric emergency department of Strasbourg University Hospital
* Child who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.
* Child (and/or his/her parental authority) who has not expressed, after information, his/her (their) opposition to the reuse of his/her health data for the purposes of this research.

Exclusion Criteria:

* Refusal of the child (and/or his/her parent) to participate in the study
* Patient's medical file not incomplete
* Child not domiciled in France.

Primary outcomes:
measure: The judgment criterion is composite in order to retrospectively evaluate the relevance of the prescription, administration and monitoring of the intranasal fentanyl (FIN) protocol.
timeFrame: Up to 2 years
measure: The judgment criterion is composite in order to retrospectively evaluate the relevance of the prescription, administration and monitoring of the intranasal fentanyl (FIN) protocol.The judgment criterion includes,
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Urgences Médico-Chirurgicales Pédiatriques - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00832546: A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers
Official title: A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hyperalgesia
Lead sponsor: TorreyPines Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 18
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin induced pain in hyperalgesia.


Eligibility criteria: Inclusion Criteria:

* Healthy males, age 21-55

Exclusion Criteria:

* Allergy to study drug

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Diego
name: Mark Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05853146: Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
Official title: Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetus Pulse Monitoring
Keywords: fetus
pulse
monitoring
pregnancy
Lead sponsor: Oxitone Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women in the third trimester of pregnancy with one fetus.

Brief summary: The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.

Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.

Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.

Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the age of 18-50

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications

Primary outcomes:
measure: fetus pulse
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00584246: Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Official title: Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Restless Legs Syndrome
Keywords: Restless legs syndrome
RLS
Pregabalin
Lyrica
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
2. Patients must report some degree of pain which occurs on a regular basis.
3. Age 18 years to 80 years.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
6. Willing and able to provide informed consent.
7. Willing to comply with protocol. -

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
5. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
6. Legal incapacity or limited legal capacity.
7. Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
8. Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
9. Presence of severe daytime sleepiness.
10. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
11. Patients taking dopamine agonists for any condition other than RLS. -

Primary outcomes:
measure: International RLS Study Group Severity Scale (IRLS)
timeFrame: 2 months
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 2 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Theresa A Zesiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02265146: ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study
Official title: Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Atherosclerosis
Keywords: Lipid Core Plaques (LCPs)
Vulnerable Plaque
Near Infrared Spectroscopy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing clinically-indicated Near Infrared Spectroscopy (NIRS) among various participating centers.

Brief summary: This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).


Eligibility criteria: Inclusion Criteria:

1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence of major adverse cardiac events
timeFrame: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/(South Georgia) VA Health Care System
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Emmanouil S Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597046: Qualitative Interviews With Healthcare Professionals
Official title: PLANNING PHASE- Qualitative Interviews With Healthcare Professionals to Assist in the Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement (TKR) Surgery for the Treatment of Knee Arthritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Keywords: TKR
Lead sponsor: Invibio Ltd
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare Professionals attending the AAKHS conference, Dallas during Thursday 3rd to Saturday 5th November 2022.

Brief summary: PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.

Detailed description: The interviews for the SYNC01-PP-USA project will be conducted in person at the American Association of Hip and Knee Surgeons (AAHKS) annual conference in Dallas, Texas, USA during the 3rd, 4th, and 5th November 2022. The interviews will take approximately 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthcare Professionals who currently care for patients who have undergone Total Knee Replacement surgery.
* Healthcare Professionals who, in the opinion of the Investigator, can understand the project, co-operate with the interview process and are willing to be interviewed in person.
* Healthcare Professionals who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.

Primary outcomes:
measure: Interview
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: AAKHS conference, Dallas
state: Texas
Study officials:
References:
Clinical trial NCT03181646: Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Official title: Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypoxic-Ischemic Encephalopathy
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Citicoline, is a naturally occurring compound and an intermediate in the metabolism of phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both these molecules enter the brain separately and by passing through the blood-brain barrier where they act as substrates for intracellular synthesis of CDP-choline . This drug has been widely used in adults who suffer from acute ischemic strokes for than 4 decades with good results and has been proved to have a very good safety profile as well. It has various therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.

1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin synthesis and by inhibiting the release of free fatty acids . By protecting membranes, citicoline inhibits glutamate release during ischemia. In an experimental model of ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.
2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other neurotransmitters, and decreases free radical formation Therefore, citicoline simultaneously inhibits different steps of the ischemic cascade protecting the injured tissue against early and delayed mechanisms responsible for ischemic brain injury.
3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased neuroplasticity with decrease of neurologic deficits and improvement of behavioral performance.

Considering these pharmacologic properties of citicoline, we are planning to see its effects in newborns who have HIE which causes a global acute ischemic changes in developing brain.


Eligibility criteria: Inclusion Criteria:

* • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or operation theatre of our hospital.

  * Outdoor patients presenting within 24 hours of delivery

Exclusion Criteria:

* • Outborn babies presenting after 24 hours of delivery.

  * Patients with severe congenital malformations
  * Babies born extremely prematurely (less than 28 weeks)

Primary outcomes:
measure: effect on sucking
timeFrame: 06 months after start of study
measure: discharge time
timeFrame: 06 months after start of study
measure: effect on seizures
timeFrame: 06 months after start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Department of Pediatrics
state: Punjab
Study officials:
References:
Clinical trial NCT01318746: The Circadian Rhythm of Potassium and Cystatin C
Official title: The Circadian Rhythm of Potassium and Cystatin c and the Day-to-day Variability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmias
Sudden Cardiac Death
Keywords: change of potassium amount, circadian and day-to-day variability
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2011-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy persons compared to patients with renal failure

Brief summary: The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In patients with renal failure, the potassium value is not stable and tends to raise. Until now there are no data available if the potassium value has a circadian rhythm and if there are individual changes from day to day.

Detailed description: Potassium and cystatin c is measured every 2 hours during 24 hours, twice. There are two groups of patients: Patients with eGFR \< 60 ml/min and patients with eGFR \> 60 ml/min

Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* normal renal function and impaired renal function (GFR \< 60 ml/min) respectively

Exclusion Criteria:

* pregnancy
* anaemia (Hb\<10 mg/dl)

Primary outcomes:
measure: Potassium rhythm
timeFrame: twice in 24 hours
Secondary outcomes:
measure: Potassium value in renal failure
timeFrame: twice in 24 hours
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Study officials:
affiliation: Department of Nephrology and Hypertension, University of Erlangen-Nürnberg Medical School
name: Roland E. Schmieder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt ST, Ditting T, Deutsch B, Schutte R, Friedrich S, Kistner I, Ott C, Raff U, Veelken R, Schmieder RE. Circadian rhythm and day to day variability of serum potassium concentration: a pilot study. J Nephrol. 2015 Apr;28(2):165-72. doi: 10.1007/s40620-014-0115-7. Epub 2014 Jul 3.
Clinical trial NCT05932446: A Study to Compare Two Formulations of LY3819469 in Healthy Participants
Official title: A Single Dose Study to Assess the Pharmacokinetics of 2 Formulations of LY3819469 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
* Are male or women not of childbearing potential

Exclusion Criteria:

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
* Have lost or donated blood of more than 450 mililitres (mL) within 3 months

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469
timeFrame: Predose on day 1 up to postdose on day 85
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469
timeFrame: Predose on day 1 up to postdose on day 85
measure: PK: Maximum Observed Concentration (Cmax) of LY3819469
timeFrame: Predose on day 1 up to postdose on day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
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: