louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03860467: Epileptic Seizures in Intensive Care Units
Official title: Epileptic Seizures in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epileptic Seizure
Keywords: Status epilepticus
Electroencephalogram
Intensive Care Unit
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients (i.e., ≥18 years of age) admitted to the ICUs at the University Hospital Basel that suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay

Brief summary: This retrospective observational cohort study is to assess and analyze clinical, electroencephalographic, laboratory, comorbidity, and treatment characteristics of Intensive care unit (ICU)-patients with epileptic seizures and to subsequently compare their characteristics with ICU-patients with status epilepticus (SE).

Detailed description: The aim of this retrospective observational cohort study is to get further insight into adult patients with epileptic seizures in ICUs in an academic tertiary medical care center regarding frequency, clinical and electroencephalogram (EEG) characteristics, treatment, course and outcome. This data could help understanding the epidemiology (including risk factors, influence of EEG), and to guide management and improve outcomes of affected patients.

Eligibility criteria: Inclusion Criteria:

* admitted to the ICU at the University Hospital Basel
* suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay

Exclusion Criteria:

* patients with epileptic seizures transforming into Status epilepticus (SE)

Primary outcomes:
measure: Frequency of epileptic seizures
timeFrame: between 01.01.2005 and 19.12.2018
Secondary outcomes:
measure: Number of epileptic seizures captured by EEG
timeFrame: between 01.01.2005 and 19.12.2018
measure: Number of epileptic seizures diagnosed on the basis of clinical symptoms alone
timeFrame: between 01.01.2005 and 19.12.2018
measure: Length of epileptic seizure (time)
timeFrame: between 01.01.2005 and 19.12.2018
measure: Semiological feature of epileptic seizure (i.e. seizure types)
timeFrame: between 01.01.2005 and 19.12.2018
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine, University Hospital Basel
Study officials:
affiliation: Clinic for Intensive Care Medicine, University Hospital Basel
name: Raoul Sutter, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner AS, Semmlack S, Frei A, Ruegg S, Marsch S, Sutter R. Seizures and risks for recurrence in critically ill patients: an observational cohort study. J Neurol. 2022 Aug;269(8):4185-4194. doi: 10.1007/s00415-022-11038-6. Epub 2022 Mar 2.
Clinical trial NCT01282567: Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
Official title: Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is focused on the evaluation of an original control algorithm that computes appropriate subcutaneous insulin infusion in response to continuous glucose measurements The results during a 24-hour closed-loop period will be compared with those of the open-loop. The implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary a phase of identification of the parameters of the model (insulin pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of the damping parameters of EDS.

The present study aims to formalize this procedure of identification/optimization of the parameters of the model and controller EDS. They will be determined in type -1 diabetic patients using insulin therapy and under conditions free from disturbances such as those generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will determine this procedure: blood glucose, insulin concentration and insulin doses.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patients (age : 18-70)
* Diabetes duration higher than three years
* Insulin pump with Humalog®
* Hospitalized for a 24-hour glucidic fast test
* Written informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Acute infectious disease
* Corticoid treatment
* Creatinine clearance \<40 ml/mn
* Patients using Apidra® or Novorapid®
* People major being the object of a legal protection (safeguard of justice, supervision, trusteeship)

Primary outcomes:
measure: Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
affiliation: Rennes University Hospital
name: jean-yves poirier
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: isabelle guilhem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733667: A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Official title: A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Synechia
Keywords: synechia
Fess
sinus surgery
Lead sponsor: ENTrigue Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 compare the safety and effectiveness of MediENT to MeroPack after FESS.

Detailed description: MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.

Eligibility criteria: Inclusion Criteria:

1. Subject is between the ages of 18 and 65 years
2. Subject scheduled to undergo bilateral endoscopic sinus surgery
3. Subject signs IRB-approved informed consent form
4. Subject agrees to comply with all study-related procedures

Exclusion Criteria:

1. History of removal of one or both middle turbinates
2. Significant sinonasal polyps
3. Presence of marked septal asymmetry
4. Presence of significant concha bullosa, which requires surgical excision
5. Presence of non-viable tissue at the implantation site
6. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
7. Known or suspected allergy to device components
8. Participating in another clinical trial which could affect the healing of the middle turbinate
9. Uncontrolled diabetes
10. Known or suspected use of illicit drugs
11. Known or suspected alcoholism
12. Other medical illness that could prevent follow-up or increase the risk of surgery
13. Pregnant or unwilling to take pregnancy prevention measures
14. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea

Primary outcomes:
measure: Miller synechia score at 8 weeks
timeFrame: 8 weeks post endoscopic sinus surgery
Secondary outcomes:
measure: Miller Score at 4 & 8 weeks
timeFrame: 4 & 8 weeks post endoscopic sinus surgery
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California ENT Medical Group
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Ear, Nose & Throat Clinics of San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT03424967: Statistical Learning as a Predictor of Attention Bias Modification Outcome
Official title: Statistical Learning as a Predictor of Attention Bias Modification Outcome: a Preliminary Study Among Socially Anxious Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: attention-bias modification
statistical learning
social anxiety disorder
treatment outcome
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines whether the ability to extract statistical properties from the environment among treatment-seeking patients with social anxiety disorder can predict therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of social anxiety following ABM therapy.

Detailed description: All participants received 6 sessions of ABM therapy away from threat. At baseline participants also completed a gold standard statistical learning task aimed to assess participants' capacity for the extraction of statistical regularity from the environment. The aim of the study is to determine whether the basic ability to extract rules from the environment at baseline could predict clinical improvement of social anxiety symptoms.

Eligibility criteria: Inclusion Criteria:

* a signed consent form
* a primary diagnosis of social anxiety disorder
* an age of 18-65

Exclusion Criteria:

* any history or present diagnosis of psychosis
* high risk for harm to self or others
* concurrent posttraumatic stress disorder, eating disorder, or bipolar disorder
* a diagnosis of a neurological disorder (i.e., epilepsy, brain injury)
* drug or alcohol misuse
* a pharmacological treatment that is not stabilized in the past 3 months
* any concurrent psychotherapy

Primary outcomes:
measure: The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores
timeFrame: 1-2 weeks after treatment completion
Secondary outcomes:
measure: The Social Phobia Inventory scores
timeFrame: 1-2 weeks after treatment completion
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801567: Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
Official title: A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder
Schizophrenia
Healthy Controls
Keywords: Bipolar disorder
Schizophrenia
Healthy volunteer
Brain imaging
Photic stimulation
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy \[MRS\] scan) with light stimulation. To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.

Detailed description: This study will include males and females between the ages of 18 and 55 years. Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls. The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes. The procedures can also be separated into two study visits, if necessary.

Eligibility criteria: Inclusion Criteria:

* Male of female
* 18-55 years
* Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness
* On stable medication with no changes in the two weeks prior to enrollment

Exclusion Criteria:

* History of substance abuse or dependence within 3 months of enrollment
* Positive urine drug screen
* Significant medical or neurological illness
* Pregnancy
* Any contraindication to magnetic resonance scanning, including claustrophobia

Primary outcomes:
measure: Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi).
timeFrame: 42 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Brian P Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06919367: Use of Dental Age Determination Methods in Children With Type Diabetes
Official title: Evaluation of Dental Ages of Children With Type I Diabetes Using Different Dental Age Estimation Methods-A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 58
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetes mellitus who applied to Bolu Abant İzzet Baysal University Faculty of Dentistry Pedodontics Clinic between 2017 and 2024 were included.

Brief summary: The aim of this study was to determine the estimated dental age of children with type 1 diabetes by using Cameriere, Willems and Demirjian methods.

Detailed description: The different metabolic activities of children with type 1 diabetes cause significant differences between them and healthy children. Especially from a forensic point of view, special methods defined for these children are needed and dental age estimation is one of them. The aim of this study was to determine the estimated dental age of children with type 1 diabetes by using Cameriere, Willems and Demirjian methods.

Methods: Between 2017 and 2024, 58 patients with type 1 diabetes and healthy children were included in the study. Dental ages were calculated on panoramic radiographic images by 2 different dentists using Cameriere, Willems and Demirjian methods. Dental ages and their differences with chronological ages were compared by group and gender. Analyses were performed in IBM SPSS 25 program.

Eligibility criteria: Inclusion Criteria:

* 4-15 years old
* No chronic disease in addition to the diagnosis of type 1 diabetes
* Children with controlled type 1 diabetes mellitus
* No congenital tooth deficiency
* Pediatric patients with good quality panoramic radiographs were included.

Exclusion Criteria:

* Blurred or distorted radiographs,
* Missing any of the left seven permanent mandibular teeth (genesis or extraction),
* With dental abnormalities (dilaceration, supernumerary teeth) and developmental disorders (cleft lip and palate),
* Patients with incomplete medical or dental history were excluded.

Primary outcomes:
measure: dental age estimation
timeFrame: 3 months
Secondary outcomes:
measure: type 1 diabetes and dental age estimation
timeFrame: 3 months
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References:
Clinical trial NCT01524367: Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Official title: Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.

Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.

Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.

To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.

The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1 or 2 patients
* patients scheduled for orthognathic surgery (two-jaw)

Exclusion Criteria:

* severe cardiovascular disease
* allergy to dexmedetomidine
* psychological disease
* patients who cannot understand Korean

Primary outcomes:
measure: severity of emergence excitement based on Richmond agitation-sedation scale
timeFrame: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.
Secondary outcomes:
measure: emergence time
timeFrame: up to the time of eye opening,an expected average of 30 minutes.
measure: coughing grade
timeFrame: up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance hospital
Study officials:
affiliation: Yonsei University
name: Yonhee Shim
role: STUDY_DIRECTOR
References:
Clinical trial NCT04593667: Randomized Study of Accelerated Radial Arterial Hemostasis
Official title: Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Lead sponsor: Medcura Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwell Health
First posted: 2020-10-20
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: 60 patients, randomized into one of three arms
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

Detailed description: The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, \& N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.

Eligibility criteria: Inclusion Criteria:

* Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to hemostasis
timeFrame: 60 minutes
measure: Compressive Force
timeFrame: 60 minutes
Secondary outcomes:
measure: Radial Artery
timeFrame: immediately after hemostasis
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital - Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Varinder Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03556267: Regional Anesthesia of Cesarean Section
Official title: Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Obestetric
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

Detailed description: Beta trace protein is specific for CSF only and it is a quantitative analytic test.

Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* free medical history.
* free obstetric history.

Exclusion Criteria:

* high risk pregnancy.

Primary outcomes:
measure: CSF sample: serum sample
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdelrahman
Study officials:
References: