louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02443727: The Role of Oxytocin in the Perception of Faces
Official title: The Role of Oxytocin in the Perception of Infant Faces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
First posted: 2015-05-14
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this project is to study whether intranasal oxytocin (OT) affects how young adults perceive and attend to infant and adult faces. Based on existing research the investigators predict that oxytocin will facilitate the allocation of attentional resources on infant faces (compared to adult faces). The investigators also predict that oxytocin will enhance the activity of reward neural-networks associated with the perception of infant faces. The behavioral effects of OT (visual attention and face recognition) will be measured with eye-tracking while participants look at photographs of adult and infant faces. Neurological effects (the activity of emotion and reward networks) will be measured with functional Magnetic Resonance Imaging (fMRI) while participants look at infant faces on a computer screen.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Norma or corrected to norma vision
* Participants are non parents
* Able to provide written informed consent and to comply with all study procedures

Exclusion Criteria:

* Dementia or severe cognitive disorders
* Endocrine disease or malignancy
* Nasal obstruction or upper-respiratory tract infection
* Current or previous psychiatric disorder
* Current or previous use of psychoactive drugs
* Alcoholism or substance abuse
* History of seizures
* Neurological Disorder
* Previous head trauma
* Hypertension
* Cardiovascular Disease
* Claustrophobia
* ferrous metal in any part of the body

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) Data
timeFrame: 45 minutes after OT manipulation
measure: Eye movements data
timeFrame: 45 minutes after OT manipulation
Secondary outcomes:
measure: Implicit Attitudes toward infants
timeFrame: 45 minutes after OT manipulation
measure: Theory of mind
timeFrame: 45 minutes after OT manipulation
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Rodrigo A Cardenas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385627: Local Infiltration Analgesia for Foot Surgery
Official title: Local Infiltration Analgesia for Foot Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedure, Unspecified
Keywords: Foot surgery
Midfoot surgery
Hindfoot surgery
Forefoot surgery
Ankle surgery
Ankle block
Local infiltration analgesia of the ankle
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing surgery of the foot or ankle will be assessed for eligibility. We will attempt to include all adult patients receiving local infiltration analgesia of the ankle for pain management following foot or ankle surgery.

Brief summary: Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Surgery of the foot/ankle
* Intraoperative local infiltration analgesia of the ankle
* Age \>= 18 years

Exclusion Criteria:

* Inability to read and understand Danish
* Uncooperativeness (judged by investigators)

Primary outcomes:
measure: Duration of analgesia, measured as time to first pain
timeFrame: 24 hours
Secondary outcomes:
measure: Pain in the post-anaesthesia care unit, measured on the Numerical Rating Scale (NRS)
timeFrame: 24 hours
measure: Participants with failed block
timeFrame: 24 hours
measure: Pain at 6 hours postoperatively, measured on the NRS
timeFrame: 6 hours
measure: Pain at 24 hours postoperatively, measured on the NRS
timeFrame: 24 hours
measure: Cumulative opioid consumption at 24 hours postoperatively
timeFrame: 24 hours
measure: Participant satisfaction related to ankle block
timeFrame: 24 hours
measure: Unplanned admission
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Zealand Region Of Denmark
Study officials:
References:
Clinical trial NCT05301127: Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery
Official title: Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Combination of General Anesthesia to Spinal and Epidural Techniques
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.


Eligibility criteria: 1. Inclusion criteria:

   * Patients aged from 18 to50 years.
   * ASA I-II.
   * undergoing elective liposuction surgery
   * BMI from 25 to 40 kg/m2
2. Exclusion criteria:

   * Patient refusal
   * ASA III-IV.
   * Patients aged less than 18 or more than 50.
   * Body mass index \>40.
   * Any contraindications to neuro-axial block such as coagulopathy or spine deformity
   * Chronic opioid consumption,
   * History of parenteral or oral analgesic intake within the last 48hours.

Primary outcomes:
measure: morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative patient satisfaction
timeFrame: 24 hours
measure: Intraoperative surgeon satisfaction.
timeFrame: 6 hours
measure: Incidence of complications
timeFrame: 24 hours
measure: Blood loss
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT02862327: Intravenous Dexamethasone for Ropivacaine Axillary Block
Official title: Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Anesthesia
Forearm Injuries
Keywords: anaesthetic techniques
regional anesthesia
brachial plexus block
Local Anesthetic
ropivacaine
analgesia
steroid
dexamethasone
placebo
adjuvant
ultrasound guided
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block


Eligibility criteria: Inclusion Criteria:

* ASA 1,2 et 3
* surgery under axillary brachial plexus block
* aged \>18 years
* signed information consent

Exclusion Criteria:

* impaired coagulation
* contraindication to regional anesthesia or technical impossibility
* opioids or pain killers abuse or addiction
* steroids consumption in the past 6 months
* dementia or under administrative supervision
* delay of surgery to short to allow regional anesthesia
* pregnancy and breastfeeding
* allergy and contraindication to dexamethasone or ropivacaine
* anticipated bad observation of treatment
* patient enrolled in another trial

Primary outcomes:
measure: Analgesia duration after axillary brachial plexus block
timeFrame: time to first pain at surgical site, an average of 24 hours
Secondary outcomes:
measure: Motor block duration after axillary brachial plexus block Safety
timeFrame: up to block recovery, an average of 24 hours
measure: Sensory block duration after axillary brachial plexus block
timeFrame: up to block recovery, an average of 24 hours
measure: incidence of adverse event
timeFrame: 6 month
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU de Besancon
Study officials:
References:
citation: Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3):e100035. doi: 10.1136/rapm-2018-100035.
Clinical trial NCT03990727: Phenotype Correlates Genotype of Inherited Retina Dystrophies, Retinitis Pigmentosa, Con>Rod Dystrophies.
Official title: Phenotype Correlates Genotype of Inherited Retina Dystrophies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinitis Pigmentosa
Cone Dystrophy
Usher Syndromes
Retina; Dystrophy
Lead sponsor: MejoraVisionMD
Sponsor class: NETWORK
Collaborators: name: Maisonneuve-Rosemont Hospital
name: Retina and Genomics Institute
First posted: 2019-06-19
Enrollment: 17000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inherited retina dystrophies / Retinitis pigmentosa, LCA, Cone-rod dystrophy

Brief summary: Patients with retina dystrophies (retinitis pigmentosa, cone\>rods dystrophies, Usher and syndromic) will be correlated with genotype and validate inheritance mode by segregation analysis.

Detailed description: Patients with retina dystrophies (retinitis pigmentosa, cone\>rods dystrophies, Usher and syndromic, etc.) will be correlated with genotype and validate inheritance mode by segregation analysis. Ocular exam of proband, parents and two unaffected siblings is needed, retina analysis, autofluorescence and ocular coherence tomography (OCT) are needed as well as family map. Blood samples 10ml max blood extraction will be sent and genotype will be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of inherited retina dystrophy or retinitis pigmentosa
2. Must be able to perform all study tests.
3. Must be able to visit every year.

Exclusion Criteria:

1) Not willing to visit every year.

Primary outcomes:
measure: Gene-molecular variation to correlate with phenotype based on autofluorescence, retina analysis,
timeFrame: 8 years
Secondary outcomes:
measure: Preliminary Natural History
timeFrame: 5 years
Other outcomes:
Locations:
city: Merida
country: Mexico
facility: Retina and Genomics Institute
state: Yucatan
Study officials:
References:
citation: Villanueva, Adda L., et al.
citation: Villanueva, A. L., Langlois, M., Mongrain, I., Provost, S., Asselin, G., Dubé, M. P., ... & Ayyagari, R. (2015). ARRP microarray and Exome analysis revealed known and novel mutations in Mexican pedigrees. Investigative Ophthalmology & Visual Science, 56(7), 2866-2866.
Clinical trial NCT06523127: Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues
Official title: Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Brain Injuries
Post ICU
Keywords: Quality of life
Withholding of life-sustaining treatments
Withdrawal of life-sustaining treatment
Severe acute brain injury
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 14
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 acute brain injury admitted to intensive care in 2022 will be included.

Brief summary: Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.

There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.

Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.

That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.


Eligibility criteria: Inclusion Criteria:

Patients:

* with severe acute brain injury (TBI, stroke, central nervous system infection).
* admitted in the neurocritical care unit in 2022.
* followed up 24 months after ICU between 15th April 2024 and 31st August 2024.

Exclusion Criteria:

Patients:

* death in 2024,
* refusal by patient or relative.

Primary outcomes:
measure: Interpretative Phenomenological Analysis
timeFrame: 24 months after ICU discharge
Secondary outcomes:
measure: International survey among neurointensivists from ANARLF network - questionnaires
timeFrame: Month : 3
measure: International survey among neurointensivists from ANARLF network - follow-up
timeFrame: Month : 3
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Marie DAKENG, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651027: Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
Official title: An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HEPATITIS C (HCV)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.


Eligibility criteria: Inclusion Criteria:

* Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;
* Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh \>50 kg (110 lbs);

Exclusion Criteria:

* Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);
* Severe ascites and/or pleural effusion;
* Had a transplanted kidney, heart or liver;

Primary outcomes:
measure: PK parameters
timeFrame: 8 day
Secondary outcomes:
measure: safety and tolerability
timeFrame: 8days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02243527: Respiratory Muscles and Inspiratory Muscle Training
Official title: Effects of Inspiratory Muscle Training on Respiratory Muscle Mechanics and Haemodynamics in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscles
Breathing Exercises
Keywords: Exercise
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2014-09-18
Enrollment: 25
Sex: MALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effects of inspiratory muscle training (IMT) remain controversial. Many studies have examined the effect IMT has on exercise performance, but any changes to the body that come from IMT have yet to be looked at.

This study will look at how someone breathes can change after IMT. Understanding how IMT changes the body can help us use IMT in different treatments.


Eligibility criteria: Inclusion Criteria:

* Recreationally active, 'Moderate' or 'High' category on International Physical Activity Questionnaire Short form questionnaire
* Able to read and understand English
* Pulmonary function within normal limits

Exclusion Criteria:

* History of or currently smoking
* History or current symptoms of cardiopulmonary disease (including asthma and exercise induced asthma)
* Currently participating and training in a sport at a provincial, national, or international level
* Ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
* Allergies to latex or local anesthetic
* Contraindications to exercise testing

Primary outcomes:
measure: Diaphragm Electromyography
timeFrame: Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
Secondary outcomes:
measure: Accessory Respiratory Muscle Activation
timeFrame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Other outcomes:
measure: Dyspnoea
timeFrame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
measure: Muscle Oxygenation
timeFrame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Locations:
city: Vancouver
country: Canada
facility: Centre for Heart Lung Innovation
state: British Columbia
Study officials:
affiliation: University of British Columbia/Centre for Heart Lung Innovation
name: Jordan A Guenette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100227: (18)F-FDG PET Database of Adult Healthy Individuals
Official title: (18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide.

Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Focal Hypometabolism on interictal \[18F\]-FDG PET is a hallmark of the Seizure Onset Zone as well as surrounding areas. Using \[18F\]-FDG PET is thus particularly useful to determine the seizure onset zone of epileptic patients and thus to guide surgical treatment when antiepileptic drugs fail.

Interpretation of PET images primarily relies on standard visual analysis, but statistical analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the diagnostic yield of PET. Over the past years, some authors have thus reported that the use of SPM can result in greater sensitivity and specificity of PET imaging in patients with partial epilepsy.

In order to perform statistical analysis of PET images to compare brain metabolism of epileptic patients and healthy controls, it is necessary to collect a normative database of \[18F\]-FDG PET images in healthy controls.

The purpose of this study is (i) collect a normative database of \[18F\]-FDG PET images in healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of \[18F\]-FDG PET scanning.


Eligibility criteria: Inclusion Criteria:

* healthy adult controls
* Age 20-65 years
* Signed informed consent form.

Exclusion Criteria:

* Contraindication to the MRI
* Known neurological disease
* Adult subject to legal protection measure.
* Women of childbearing age who do not have effective contraception

Primary outcomes:
measure: Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.
timeFrame: Day 1
Secondary outcomes:
measure: Test-reliability
timeFrame: Week 2
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Julien JUNG, MD
role: PRINCIPAL_INVESTIGATOR
References: