louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06806475: Sustained Ketamine Effectiveness for Suicidal Ideation
Official title: SUSTAINED KETAMINE EFFECTIVENESS for SUICIDAL IDEATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression - Major Depressive Disorder
Suicide
Keywords: suicide
depression
major depressive disorder
ketamine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 128
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: Adult patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis over the period from June 2022 to March 2024

Brief summary: As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated.

Patients are systematically reassessed twice in the month following the last infusion, to ensure that the suicidal crisis is progressing. Psychometric assessments are part of routine care, to ensure systematic evaluation of psychopathology, intensity of depression and suicidality.

Therefore existing data were re-used from the medical records of patients who had received ketamine infusions to assess the effect of ketamine on suicidal ideation and behaviour.


Eligibility criteria: Inclusion Criteria:

* Patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis
* over 18 y.o

Exclusion Criteria:

* Opposition to data use
* Subject deprived of liberty (by judicial or administrative decision)
* Subject protected by law (guardianship or curatorship)
* Subject not affiliated to a social security system

Primary outcomes:
measure: suicidal ideation at 7 days after IV ketamine administration
timeFrame: 7 days
Secondary outcomes:
measure: suicidal ideation at 1 month after IV ketamine administration
timeFrame: 1 month
measure: Severity of depressive symptomatology at 7 days
timeFrame: 7 days
measure: Severity of depressive symptomatology at 1 month
timeFrame: 1 month
measure: suicidal ideation at 7 days after IV ketamine
timeFrame: 7 days
measure: suicidal behavior at 1 month after IV ketamine
timeFrame: 1 month
measure: suicidal behavior at 3 months after IV ketamine
timeFrame: 3 months
measure: suicidal ideation at 1 month after IV ketamine
timeFrame: 1 month
measure: suicidal ideation at 3 months after IV ketamine
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital, Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Emilie OLIE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151475: Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)
Official title: Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of HE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Hepatic Encephalopathy
Keywords: liver cirrhosis
hepatic encephalopathy
ammonia
cerebral blood flow
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatic encephalopathy

Brief summary: We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate; brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute episode of hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* patients with an acute episode of hepatic encephalopathy

Exclusion Criteria:

* previous stroke

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Gitte Dam
Study officials:
References:
Clinical trial NCT00792675: Effect of Exercise on the Disease Activity of Rheumatoid Arthritis
Official title: Evaluation of the Effect of Exercise on Disease Activity and Immune Parameters in Persons With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: exercise
disease activity
inflammation
resistance training
rehabilitation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
name: Nebraska Chapter Arthritis Foundation
First posted: 2008-11-18
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weightlifting.

Detailed description: The goal of this study was to evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis. It was hypothesized that persons would have less inflammation associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weighlifting. Immune parameters were measured to determine potential mechanisms responsible for changes in inflammation with exercise.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of RA according to the ACR 1989 Criteria at least 6 months prior to enrollment in the study, but not longer than 12 years
* age 19 to 65 years old
* stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids
* currently exercise \< 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate
* Subjects must pass the Physical Activity Readiness Scale Questionnaire (PAR-Q)

Exclusion Criteria:

* other serious health problems
* intra-articular injection within 6 weeks
* total joint replacement of the large joints
* use of beta-blockers
* inability to complete the submaximal exercise test

Primary outcomes:
measure: Swollen Joint Count
timeFrame: 12 Weeks
measure: Tender Joint Count
timeFrame: 12 Weeks
Secondary outcomes:
measure: Pain (visual Analog Scale)
timeFrame: 12 Weeks
measure: Modified-Health Assessment Questionnaire
timeFrame: 12 Weeks
measure: Estimated Aerobic Capacity (VO2max)
timeFrame: 12 weeks
measure: SF-36
timeFrame: 12 Weeks
measure: Patient Global Assessment
timeFrame: 12 Weeks
measure: Practitioner Global Assessment
timeFrame: 12 Weeks
measure: Timed-Stands Test
timeFrame: 12 Weeks
measure: 50 Foot Walk Test
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Physical Activity Lab, University of Nebraska Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Laura D Bilek, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109275: Connectome Characterization With Aging
Official title: Connectome Characterization With Aging Using Functional and Structural MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this project is to develop a new model to characterize brain connectivity and its changes with aging. This characterization will be based on new sensitive and specific markers, allowing a better understanding of structural and functional brain networks. To this end, two complementary MRI methods will be developed: 1) Resting-state functional MRI (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and reconstruct fiber tractography of patient's brains. In combination with conventional MRI, both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of cortical regions, so- called "Connectome". Once generated, brain networks will be quantified through numerous graph metrics, such as graph density, global efficiency and assortativity (etc.), reflecting the organization and topology of subjects' connectivity with aging.


Eligibility criteria: Inclusion Criteria:

* Volunteers (Men and women) aged between 18 and 50 years
* No neurological or psychiatric diseases

Exclusion Criteria:

* MRI contraindications
* Pregnant women or nursing women
* Persons under guardianship or any other administrative or deprivation of liberty or of right

Primary outcomes:
measure: Functional and structural connectivity MRI marker : resting-state fMRI
timeFrame: End of study (one year)
measure: Functional and structural connectivity MRI marker : Functional connectivity
timeFrame: End of study (one year)
measure: Functional and structural connectivity MRI marker : Diffusion tensor
timeFrame: End of study (one year)
measure: Functional and structural connectivity MRI marker : Structural connectivity
timeFrame: End of study (one year)
measure: Functional and structural connectivity MRI marker : SPM software
timeFrame: End of study (one year)
Secondary outcomes:
measure: Metrics of functional connectivity
timeFrame: End of study (one year)
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Sabine Mouchet-Mages, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284775: Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
Official title: Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. Over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. Although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma.

In this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes will be technical feasibility and device safety. The secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.


Eligibility criteria: Inclusion Criteria:

* adult patients
* undergoing transsphenoidal surgery
* diagnosis of pituitary adenoma on pre-operative MRI
* able to provide consent

Exclusion Criteria:

* patients less than 18 years of age
* patients undergoing transcranial surgery
* diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma
* unable to provide consent e.g., mental illness or later withdrawing consent.

Primary outcomes:
measure: Technical feasibility
timeFrame: Intraoperative
measure: Device safety
timeFrame: Intraoperative
Secondary outcomes:
measure: Radiological resection
timeFrame: Early post-operative
measure: Endocrinological remission
timeFrame: Early post-operative
measure: Postoperative complications
timeFrame: Early post-operative
measure: Operating time (minutes)
timeFrame: Intra-operative
measure: Length of stay (days)
timeFrame: Early post-operative
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
Study officials:
References:
Clinical trial NCT02909075: A Study to Assess Thymic Function Using PET/CT and MRI
Official title: An Initial Study of FDG-PET/CT and MRI to Assess Thymic Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CD34 Selected Peripheral Blood Stem Cell Graft
Keywords: PET/CT
MRI
Assess Thymic Function
16-1244
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK BMT clinic

Brief summary: The purpose of this study is to see if a positron emission tomography/computed tomography (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan and a MRI before and after the participants transplantation.


Eligibility criteria: Inclusion Criteria:

* Patient's age is ≥18 or ≤65 years old.
* Patients must have a plan to receive a CD34-selected peripheral blood stem cell graft.

Exclusion Criteria:

* Patient is not able to undergo MR imaging due to any contraindication to MRI based on departmental MR questionnaire (e.g. past gadolinium allergies, failure of metallic screening, claustrophobia, inability to lay flat for duration of the study, inability to hold breath, etc.)
* Pregnant or breastfeeding.

Primary outcomes:
measure: change in thymic size
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schoder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02070575: Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence
Official title: Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: PSA
Human Kallikrein 2
locally resected prostate cancer
biochemical recurrence
14-041
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 200
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to investigate if a new blood test looking at PSA and a group of PSA related proteins in a patient's blood can indicate which men after surgery with a rising PSA could benefit from treatment, and/or indicate which men are at higher risk for recurrence before initial treatment is given.


Eligibility criteria: Inclusion Criteria:

* All patients treated with radical prostatectomy that develop a rising serum PSA ≥ 0.05ng/ml and have not received any kind of additional therapy.
* Patients who have had additional therapy post radical prostatectomy are eligible for this study if ≥1 year has passed since treatment and the patient develops a rising serum PSA ≥0.05ng/ml.

Exclusion Criteria:

* Previous additional therapy for prostate cancer, less than 1 year ago
* No evidence of rising PSA
* Patients unwilling to undergo venesection

Primary outcomes:
measure: profile of a panel of kallikrein related serine proteases in the blood
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vincent Laudone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04225975: Neonate Cerebral Activity in Immediate Post Partum
Official title: Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anoxia-Ischemia, Brain
Neonatal Encephalopathy
Keywords: Anoxia-Ischemia, Brain
postpartum
Electroencephalography
Cerebral oxymetry
Near Infrared spectroscopy
EEG
NIRS
Neonate
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.

In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.


Eligibility criteria: Inclusion Criteria:

* Full term neonates between 36 and 41 weeks Gestational Age

Exclusion Criteria:

* Premature neonates
* Neonates of twin pregnancy
* Suspicion of congenital malformation seen in antenatal ultrasound
* Any pathology requiring pediatric care from birth
* Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria

Primary outcomes:
measure: Temporal correlation with EEG
timeFrame: within the 5 minutes after birth
measure: time-frequency correlation with EEG
timeFrame: within the 5 minutes after birth
measure: temporal correlation with NIRS signals
timeFrame: within the 5 minutes after birth
measure: time-frequency correlation with NIRS signals
timeFrame: within the 5 minutes after birth
Secondary outcomes:
measure: Mode of delivery correlation with temporal and EEG data
timeFrame: within the 5 minutes after birth
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01879475: Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
Official title: Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: C.Surgical Procedure; Cardiac
Haemorrhage.
Lead sponsor: Medtrade
Sponsor class: INDUSTRY
Collaborators: name: The Clinical Trial Company
First posted: 2013-06-17
Enrollment: 200
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: The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* The patient must be equal or greater than 18 years old
* The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
* The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
* The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
* The patient must provide written informed consent using a form that is reviewed and approved by the IEC

Exclusion Criteria:

* The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
* The patient has a known hypersensitivity to materials of bovine origin
* The patient does not wish to receive materials of bovine or shellfish origin for any reason

Primary outcomes:
measure: Haemostasis success
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
state: East Yorkshire
Study officials:
affiliation: Blackpool Victoria Hospital NHS trust
name: Russell Millner, MD FRCS
role: STUDY_CHAIR
References: