louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02785055: Neuraxial Ultrasound for Thoracic Epidural Placement
Official title: Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Epidural
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 70
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: This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.

Detailed description: In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology Classification I-IV
* thoracic surgery
* abdominal surgery

Exclusion Criteria:

* contraindications to epidural catheter
* pregnancy
* coagulopathy
* infection (localized)
* allergy to local anesthetics

Primary outcomes:
measure: Time to epidural space identification
timeFrame: Estimated 10 minutes
Secondary outcomes:
measure: Needle passes
timeFrame: Estimated 10 minutes
measure: Needle skin punctures
timeFrame: Estimated 10 minutes
measure: Pain Score
timeFrame: Through study completion, estimated 4 hours
measure: Working epidural
timeFrame: Through study completion, estimated 4 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: David Auyong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auyong DB, Hostetter L, Yuan SC, Slee AE, Hanson NA. Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):204-209. doi: 10.1097/AAP.0000000000000540.
Clinical trial NCT06439355: Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
Official title: Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Parkinson's Disease and Lewy Body Disease
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:

* healthy volunteers
* patients with early Parkinson's disease
* patients with incipient Lewy body disease.

To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.

This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers:

* Person who has given written consent
* Adult
* Enrolled in the national register of healthy volunteers
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* No cognitive complaints and normal neurological assessment

Patients with idiopathic Parkinson's disease:

* Person who has given written consent
* Adult
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for established or probable IPD

Patients with Lewy body disease:

* Person who has given written consent
* Adult
* Fasting \> 2 hours prior to PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for probable or possible LBD

Exclusion Criteria:

* Non-affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person subject to a court order
* Pregnant, parturient or breast-feeding women
* Major unable to give consent
* MMSE score \< 15 and/or MoCA \< 10
* Known infection with COVID-19 in the 6 months prior to inclusion
* Active smoker (\> 4 cigarettes per day on a regular basis)
* Subject with pacemaker (contraindication for bioelectrical impedancemetry)
* Diabetic (type 1 or type 2)
* Taking medication (in progress at the time of the study) that interferes with gustation

Primary outcomes:
measure: Average latency of taste-evoked potentials
timeFrame: After a 2-hour fasting period
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06634355: Placental Transfer of Sugammadex in the Human Placental Perfusion Model
Official title: Placental Transfer of Sugammadex in the Human Placental Perfusion Model
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Keywords: sugammadex
ex-vivo placenta perfusion model
placental transfer
pregnancy
anesthesia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Preclinical research raised concern regarding the foetal effects of using sugammadex during pregnancy. However, to the best of our knowledge, the placental transfer of sugammadex has never been measured. As these data would be critical in assessing the foetal effects after maternal administration of sugammadex, it is warranted to measure the placental transfer of sugammadex. The aim of this project is to measure the placental transfer of sugammadex in the human placenta by using the ex vivo human placenta perfusion model.


Eligibility criteria: Inclusion Criteria:

* informed consent signed
* (placenta of a) pregnant women with an uncomplicated pregnancy and delivery

Exclusion Criteria:

* chronic medication use during pregnancy
* maternal diseases during pregnancy (including diabetes mellitus, hypertension, thyroid dysfunction), or any infection (chorioamnionitis and toxoplasmosis, other, rubella, cytomegalovirus, herpes infections, or a positive anti-HIV, anti-hepatitis B virus, or anti-hepatitis C virus serology)

Primary outcomes:
measure: Foetal-maternal ratio of the drug
timeFrame: On the same day as collection of placenta
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: University Hospital, Gasthuisberg
name: Kristel Van Calsteren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Sarah Devroe, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404455: Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Volume Variation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 20
* 2. elective off-pump coronary artery bypass graft

Exclusion Criteria:

* 1. arrhythmia
* 2.EF \<40%
* 3.valvular heart dz
* 4.pul HTN
* 5.PAOD
* 6.lung dz
* 7.NYHA IV
* 8.ESRD

Primary outcomes:
measure: The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure
timeFrame: 30 min
Secondary outcomes:
measure: Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure
timeFrame: 30 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05944055: 25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death
Official title: Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Dysplasia
Vitamin D Overdose
Keywords: vitamin D
Overdoses
Bronchopulmonary Dysplasia
Preterm infants
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 173
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants hospitalized in the NICU at Hôpital Femme Mère Enfant, Bron, France. With a measure of 25OHD each month from the first month of life, as routinely recommended in this NICU.

Brief summary: Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an increased mortality and an increased lung injury. Such vitamin D overdose has been frequently reported in hospitalized neonates receiving the current supplementation.

The hypothesis is that vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among infants born below 31 weeks gestational age excluding infants with vitamin D deficiency.

This retrospective cohort study will include all infants born before 31 weeks of gestation (WG), who were hospitalized in a tertiary neonatal intensive care unit (NICU) during at least 10 days, for who at least one 25OH vitamin D determination was performed before 36 WG corrected age and whose parents are not opposed to the study. A descriptive analysis of the cohort depending on the occurrence of vitamin D overdose will be performed. A multivariate analysis will determine if vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among preterm infants, adjusting on the covariates known to be associated with bronchopulmonary dysplasia.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria \* :
* Infant born before 31 weeks of gestation.
* hospitalized in the NICU during at least 10 days
* with at least a 25OH-D determination available before 36 weeks corrected age

Exclusion Criteria:

-Infant with at least a 25OH-D below 50 nmol/L

Primary outcomes:
measure: Bronchopulmonary dysplasia or death
timeFrame: The outcome will be assessed at 36 weeks corrected age.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT02357355: Driving Ability in Patients With CMT 1A
Official title: Driving Ability in Patients With CMT 1A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CMT 1A
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The disease can result in difficulties with strength and balance as well as in foot deformities such as high arches, hammer toes, and tight ankles. Because of these difficulties, the disease may affect driving, especially because driving requires quick responses at times such as slamming on the brakes or turning the steering wheel quickly. The following study determines driving performance in individuals who have CMT 1A.

Detailed description: Individuals with CMT 1A will drive in a driving simulator, which involves a car located in a room in the University of Iowa Hospitals and Clinics (UIHC). Individuals will drive in the car as if they are driving in real life and the whole experience is like playing a car video game with a big animated screen. The driving results will be compared to similar aged patients who don't have CMT 1A and have also taken the driving test. If patients with CMT 1A do have driving difficulties compared to those who do not have CMT 1A, the results of the study will try to help patients with CMT1A drive better by ultimately creating devices that might help them use the steering wheel or brake pedal in a safer way.

Eligibility criteria: Inclusion Criteria:

* Have CMT 1A
* Have a valid driver's license

Exclusion criteria:

* History of other types of neuropathy (other than CMT 1A)
* History of blindness, seizures, or stroke, dementia/cognitive dysfunction

Primary outcomes:
measure: Driving Error Rate
timeFrame: 1 year
Secondary outcomes:
measure: Deceleration speed
timeFrame: 1 year
measure: Time to braking
timeFrame: 1 year
measure: Time to apply steering maneuvers
timeFrame: 1 year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Nivedita U. Jerath, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180214: Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.
Official title: The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Goiter
Thyroid Nodule
Keywords: ketorolac, superficial cervical plexus block, thyroidectomy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-50 years
* ASA I-II patients
* Patients going to do thyroid surgeries under general anesthesia

Exclusion Criteria:

* Patient refusal
* Known history of sensitivity to the drug used in the study
* Drug abuse
* Infection at the site of the block
* Presence of coagulopathy

Primary outcomes:
measure: 1st analgesic requirement
timeFrame: 24 hours
Secondary outcomes:
measure: analgesic consumption
timeFrame: 24 hours
measure: postoperative pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Faculty of Medicine
Study officials:
References:
Clinical trial NCT02482714: Life Quality Determinant Assessment of Fibromyalgia Patients
Official title: Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Keywords: Quality of Life
Physical Activity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.


Eligibility criteria: Inclusion criteria:

* Age group : 20 to 60
* Male or female
* American College of Rheumatology criteria
* Social Security beneficiary
* Informed consent of the patient
* Patient informed of the medical examination prior to inclusion
* Patient residing in the Bas-Rhin area

Exclusion Criteria:

* No medical objections to performing a stress test
* Any cardio-respiratory and musculoskeletal affection preventing physical activity
* Any particular clinical form disease
* Patient in situation of exclusion
* Subject incapacity to understand informed consent
* Patient deprived of freedom or under the protection of a conservator
* Pregnancy or breast-feeding

Primary outcomes:
measure: Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)
timeFrame: 6th month
Secondary outcomes:
measure: Score on questionnary Short Form (36) SF36
timeFrame: 6th month
measure: Measurement of displacement with Global Positioning System GPS
timeFrame: 6th month
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jehan Lecocq, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487214: Internet-based, Naturalistic Evaluation of Tolerability and Individual Patient Target Pressures With Bimatoprost 0.03% in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with either open-angle glaucoma or ocular hypertension at 41 centers in the United States

Brief summary: The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with bimatoprost in "real-world" settings


Eligibility criteria: Inclusion Criteria:

* Patients with either open-angle glaucoma or ocular hypertension were eligible if they needed bilateral IOP reduction beyond what was achieved with their current medication, or if they were intolerant of other IOP-lowering medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT00168714: Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
Official title: Avonex Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Exposure Delayed Effects
Multiple Sclerosis
Pregnancy
Keywords: AVONEX
Pregnancy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 329
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with MS who were exposed to Avonex in the US

Brief summary: The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.


Eligibility criteria: Key Inclusion Criteria:

* Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy.
* Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
* Provide verbal consent to participate in the Registry.
* Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Record and analyze birth defects and spontaneous fetal losses
timeFrame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
measure: Record and analyze pregnancy outcomes
timeFrame: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Kendle
state: North Carolina
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: