louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05224414: Interpretation Bias as a Mechanism of Treatment Response in OCD
Official title: Interpretation Bias as a Mechanism of Treatment Response in OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.

Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.


Eligibility criteria: Inclusion Criteria:

* 1) OCD Institute patients
* 2) adults (\> 18 years old)
* 3) able to complete a computer task for 20 minutes
* 4) consent to main OCD Institute study protocol
* 5) primary diagnosis of OCD (as measured by a score of \>16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team
* 6) score of \>131 on the Obsessive Beliefs Questionnaire-44 at admission \[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\]

Exclusion Criteria:

* 1) Currently experiencing acute symptoms of psychosis
* 2) Psychotic disorder diagnosis

Primary outcomes:
measure: Change in Average Score on Yale-Brown Obsessive Compulsive Scale
timeFrame: Weeks 0, 4, and 8
Secondary outcomes:
measure: Change in Average Score on Obsessive Beliefs Questionnaire
timeFrame: Time Frame: Weeks 0, 2, 4, and 8
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01793714: Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
Official title: Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Neoplasms
Keywords: Magnetic Resonance Imaging
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
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 brain tumor involving MRI realization

Brief summary: One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years and older
* Brain tumor involving frontal and/or temporal lobe and/or insula, with scheduled neurosurgery
* Patient able of accepting protocol information
* Patient who received information about the protocol and had not expressed its opposition to participate

Exclusion Criteria:

* Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
* Claustrophobic patient
* Patients who cannot cooperate for the fMRI
* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Primary outcomes:
measure: Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL)
timeFrame: 2 years
Secondary outcomes:
measure: Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL)
timeFrame: 2 years
measure: Difference of cerebral blood flow maps obtained with ASL and fASL
timeFrame: 2 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Jean-Christophe Ferre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04509414: Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients
Official title: Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Sedation
Dexmedetomidine
Keywords: deep sedation
pediatric
dexmedetomidine
dental treatment
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.

Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.

This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.


Eligibility criteria: Inclusion Criteria:

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time 1-2hours

Exclusion Criteria:

1. any known medical records with neural or mental disorder
2. any known medical records with severe systemic disorder
3. history of sedation drug administration in recent 1 months
4. any known allergic history of dexmedetomidine, midazolam or propofol
5. morbid obesity
6. history of OSAHS or acute respiratory infection in 2 weeks
7. other conditions which the attending considers to be unfit for the trial

Primary outcomes:
measure: venipuncture acceptance
timeFrame: Day 0
Secondary outcomes:
measure: Observer's Assessment of Alertness/Sedation(MOAA/S) Score
timeFrame: Day 0
measure: remedial mask induction acceptance
timeFrame: Day 0
measure: propofol dosage
timeFrame: Day 0
measure: patients' discomfort
timeFrame: up to 24 hours
measure: hypoxemia
timeFrame: Day 0
measure: peri-operative blood pressure
timeFrame: Day 0
measure: peri-operative heart rate
timeFrame: Day 0
measure: times of intra-operative airway assistance
timeFrame: Day 0
measure: post-operative pain
timeFrame: Day 0
measure: post-operative agitation
timeFrame: Day 0
measure: discharge time
timeFrame: Day 0
Other outcomes:
measure: peri-operative satisfaction
timeFrame: up to 24 hours
measure: post-operative condition of the child
timeFrame: up to 24 hours
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
Study officials:
References:
Clinical trial NCT03046914: HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction
Official title: A Prospective Study to Prove the Usefulness of HLA-B*5801 Screening Test for the Prevention of Allopurinol-induced Severe Cutaneous Adverse Reaction in Patient With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stevens-Johnson Syndrome
Kidney Failure, Chronic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2017-02-08
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cases and historical controls
Primary purpose: PREVENTION

Brief summary: Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B\*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B\*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B\*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.


Eligibility criteria: Inclusion Criteria:

* a subject who needs an allopurinol treatment based on the physician's assessement
* a subject with chronic kidney disease (CKD)

  * CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis

    1. an estimated or measured glomerular filtration rate \<60 mL/min/1.73 m2 and/or
    2. evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests)

Exclusion Criteria:

* a subject who refuses to participate in this study

Primary outcomes:
measure: An occurrence of allopurinol-induced severe cutaneous adverse reaction
timeFrame: Before 3 months after initiation of allopurinol
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04538014: A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain
Official title: Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88434 Investigating Blood-brain Barrier Penetration, Safety, and Tolerability of Lu AF88434 in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

Detailed description: The study consists of the following parts:

* a Screening Visit
* an MRI scanning visit
* an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day \[11C\]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
* a Follow-up Visit 7 days after dosing

Eligibility criteria: Inclusion Criteria:

* The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
* The subject has a normal MRI performed during the screening period, as judged by the investigator
* The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
* The subject can tolerate confined spaces for prolonged periods of time
* The subject is suitable for radial artery blood sampling and cannulation

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply

Primary outcomes:
measure: Total distribution volume (VT) of [11C]-Lu AF88434
timeFrame: At baseline and post-dose on Day 1
measure: C(PET) of Lu AF88434
timeFrame: Day 1
measure: Area Under Curve (AUC(0-inf)) of Lu AF88434
timeFrame: Day 1
measure: Cmax of Lu AF88434
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesex
country: United Kingdom
facility: Parexel International Northwick Park Hospital (Level 7)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01364714: Biomechanical Properties in Intensive Care Unit (ICU) Survivors 12-month After Discharge
Official title: Biomechanical Properties in ICU Survivors 12-month After Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care (ICU) Myopathy
Keywords: ICU acquired weakness
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-06-02
Enrollment: 32
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: ICU survivors 12 months after discharge compared to age and gender matched controls

Brief summary: Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors report persevering limitation of physical capacity for years after discharge. Limited information is available about the underlying biomechanical properties responsible for this muscle function impairment.


Eligibility criteria: Inclusion Criteria:

* ICU length of stay \> 72 hours
* Informed consent

Exclusion Criteria:

* BMI\>30
* Neuromuscular or psychiatric disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Biomechanics and Motor Control Laboratory, Department of Exercise and Sport Sciences, University of Copenhagen
Study officials:
References:
Clinical trial NCT05090514: Ready to Read: Ready to Read: A School-Based Intervention to Promote Growth Mindset and Reading
Official title: Ready to Read: A School-Based Intervention to Promote Growth Mindset and Reading
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reading
Keywords: Reading
Growth Mindset
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Demonstration project in an underserved, urban school with children randomized to intervention group or wait-list control group.
Primary purpose: TREATMENT

Brief summary: Primary Aim/Objective: To determine if a school-based intervention promoting reading with a growth mindset framework improves student reading achievement in the intervention group compared to a wait-list comparison group of children in kindergarten through 2nd grade.

Secondary Aim/Objective: To determine if students whose parents endorse a fixed mindset with regard to student reading abilities show more improvement post-intervention than parents that endorse growth mindset.

Secondary Aim/Objective: To determine if more parents endorse growth than fixed mindset post-intervention.


Eligibility criteria: Inclusion Criteria:

* all children in kindergarten through 2nd grade and their caregivers at the targeted elementary school

Exclusion Criteria:

* Less than kindergarten or above 2nd grade

Primary outcomes:
measure: Change in Reading Achievement on the Fountas and Pinnell Benchmark Assessment System
timeFrame: Administered at baseline and through intervention completion, an average of 8 weeks
Secondary outcomes:
measure: Change in Parent Growth Mindset as applied to Reading
timeFrame: Administered at baseline and through intervention completion, an average of 8 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Irene M Loe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03078114: Central Mechanism of Manual Therapy for Low Back Pain
Official title: Central Mechanism of Manual Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Chiropractic Mutual Insurance Company Foundation
First posted: 2017-03-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of subacute low back pain
* Ability to read and understand English

Exclusion Criteria:

* Previous low back surgery
* Severe structural spinal deformity
* Neurological compromise resulting in current nerve root entrapment
* Spinal cord compression
* Tumor
* Severe spinal instability
* Severe osteoporosis
* Psychiatric disease
* Head trauma
* Spinal infection
* Known cardiovascular or metabolic disease
* Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
* Pregnancy
* Mini-Mental State Examination score \< 25
* Body Mass Index (BMI) \< 18 or \> 30
* Pain or paresthesia below the knees
* Systemic illness known to affect sensation i.e. diabetes
* Acute and/or chronic pain condition unrelated to LBP

Primary outcomes:
measure: Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing
timeFrame: Change from Pre-treatment to Post-treatment, 2 Weeks
Secondary outcomes:
measure: Change in function measured using the Oswestry Disability Index (ODI)
timeFrame: Change from Baseline to Week 2
measure: Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)
timeFrame: Change from Baseline to Week 2
measure: Change in Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from Baseline to Week 2
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Leavenworth
country: United States
facility: University of Saint Mary
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.
Clinical trial NCT03226314: Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island
Official title: Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae (Prevalence, Resistance Mechanisms and Risk Factors) in Reunion Island
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Resistance
Keywords: bacterial multi-resitance
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community patients admitted in emergency ward or in intensive care unit for any condition.

Brief summary: In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years, third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is continuously increasing. Community 3GCREB prevalence has not been studied whereas several observations made in Reunion Island hospital suggest a diffusion in community. In this situation of world-wide and regional extension of bacterial resistance, the investigator offers to study bacterial resistance to antibiotic in Reunion Island community.

Detailed description: The investigator is focused on E. coli species exhibiting BLSE or metallo-betalactamases production that could be encountered du to the increasing level of migratory flow in Reunion Island.

Fecal sample collection will be used for further investigations on bacterial typology.

Eligibility criteria: Inclusion Criteria:

Patients:

* aged over 18 years old
* admitted in emergency ward or intensive care of the university hospital of Reunion Island
* who received the patient information notice and who gave their consent
* who have a stool sample performed in the 48 hours following admission
* who understand and can read French

Exclusion Criteria:

Patients:

* transferred from a short-term, middle-term or long-term stay health facility
* who have a stool sample performed more than 48 hours following admission.

Primary outcomes:
measure: Digestive prevalence rate of 3GCREB
timeFrame: through study completion, an average of 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: Chu Reunion Island
state: Reunion Island
Study officials:
affiliation: CHU La Réunion
name: Julien JAUBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: