louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01500681: Maintenance Plasma Exchange for Neuromyelitis Optica
Official title: A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Terumo BCT
First posted: 2011-12-28
Enrollment: 9
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: Neuromyelitis optica/CNS demyelinating disease specialty clinics

Brief summary: Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for NMO.

Detailed description: Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.

Eligibility criteria: Inclusion Criteria:

* Neuromyelitis optica
* Neuromyelitis optica spectrum disorder
* Recurrent idiopathic longitudinally extensive myelitis
* Age 18 years or greater

Exclusion Criteria:

* Any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study

Primary outcomes:
measure: Number of participants who complete planned maintenance PLEX regimen
timeFrame: One year
measure: Number of participants with adverse events
timeFrame: One year
measure: Annualized clinical relapse rate
timeFrame: One year
Secondary outcomes:
measure: Median Expanded Disability Status Score (EDSS)
timeFrame: One year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dean M Wingerchuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692081: Social Competence Training for Adolescents With Borderline Intellectual Functioning
Official title: A Randomized Controlled Trial of a Social Competence Group Training for Adolescents With Borderline Intellectual Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mental Disorders
Keywords: adolescents
borderline intellectual functioning
social competence training
vocational training
group intervention
cognitive behavioral therapy
Adolescents with borderline intellectual functioning
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 77
Sex: ALL
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Emotional and behavioural problems as well as a lack of social competence are supposed to be common phenomena in adolescents with borderline intellectual functioning, consequently impairing their social and vocational integration. Considering the lack of evaluated group interventions for this population, a cognitive-behavioural training is developed and its effectiveness is examined in a population of students attending special vocational schools.

77 adolescents with borderline intelligence are enrolled participated in the study. They are randomized either to the intervention group, who received 9 group sessions over a period of 3 months additionally to the standard vocational training (Social Competence Training for Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only the standard vocational training. Outcome measures at the end of the intervention and at a 6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural observations of cognitive, emotional, and behavioural factors of social competence.


Eligibility criteria: Inclusion Criteria:

* age 16 - 23 years
* participating in special vocational training program
* elevated scores in a screening measure of behavioral/emotional disorders (CBCL or YSR T\>59)

Exclusion Criteria:

* major psychiatric disorder (psychosis, major depression, substance abuse)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Ulm
name: Lutz Goldbeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nestler J, Goldbeck L. A pilot study of social competence group training for adolescents with borderline intellectual functioning and emotional and behavioural problems (SCT-ABI). J Intellect Disabil Res. 2011 Feb;55(2):231-41. doi: 10.1111/j.1365-2788.2010.01369.x. Epub 2011 Jan 4.
Clinical trial NCT06109181: Gene Therapy for ACM Due to a PKP2 Pathogenic Variant
Official title: A Phase 1/2 Study of the Safety and Efficacy of LX2020 Gene Therapy in Patients With Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Arrhythmogenic Cardiomyopathy
PKP2-ACM
PKP2-ARVC
Keywords: Arrhythmogenic Cardiomyopathy
ACM
Cardiomyopathy
ARVC
Arrhythmogenic Right Ventricular
Arrhythmogenic Right Ventricular Dysplasia
Genetic cardiomyopathy
Gene Therapy
PKP2 Gene
Plakophilin-2
LX2020
HEROIC-PKP2
Ventricular Arrhythmia
PVCs
Sudden Cardiac Death
Cardiac Arrest
Lead sponsor: Lexeo Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM


Eligibility criteria: Selected Inclusion Criteria:

* Adults with a clinical diagnosis of ACM meeting the 2010 revised Task Force Criteria (TFC)
* Genetic testing documenting a pathogenic or likely pathogenic variant in PKP2
* Frequent premature ventricular complexes (PVCs)
* Implantable cardioverter-defibrillator (ICD) implantation ≥ 12 weeks prior to the pre-screening MRI
* Left ventricular ejection fraction ≥ 40%

Selected Exclusion Criteria:

* Evidence of variant(s) in addition to PKP2 that meets the standard criteria to be considered pathogenic or likely pathogenic for ACM
* Other cardiac abnormalities as specified in the protocol
* New York Heart Association Functional Class IV at the time of consent
* History of prior gene transfer therapy

Primary outcomes:
measure: Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Selected Exploratory
timeFrame: 12 months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Lexeo Therapeutics
name: LEXEO Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01702181: A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
Official title: A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, Eczema
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 92
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: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* Adult subjects 18-65 years of age
* Diagnosis of atopic dermatitis (AD)
* AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
* Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.

Exclusion Criteria:

-Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening

Primary outcomes:
measure: Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
timeFrame: 28 days
measure: Measurement of drug levels in the blood of treated patients
timeFrame: 28 days
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) of Disease Severity at Week 4
timeFrame: 28 Days
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arizona
city: Irvine
country: United States
state: California
city: Orange Park
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Carmel
country: United States
state: Indiana
city: Berlin
country: United States
state: New Jersey
city: High Point
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT07007481: Purrble's Soothing Touch for Eating Disorders and Autism
Official title: SOOTH-ED: Purrble's Soothing Touch for Eating Disorders and Autism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Disorders
Autism Spectrum Disorder
Keywords: Eating Disorders
Autism
Sensory Porcessing
Emotion Regulation
Purrble
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the potential therapeutic benefits of the Purrble intervention, a tangible device designed to assist with in-situ emotion regulation, for individuals on the South London and Maudsley NHS Trust (SLaM) Eating Disorders outpatient service waiting list. By examining its effects on emotion regulation, sensory sensitivity, depression, anxiety, and motivation for treatment engagement, the study seeks to offer empirical evidence on the efficacy of the Purrble as a supportive tool while patients are on the waiting list for formal outpatient treatment.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled on the South London and Maudsley NHS Foundation Trust (SLaM) Eating Disorders Outpatient Service waiting list
* Confirmed diagnosis of an ED.
* Participants aged 18 and above.
* Willing to commit to the duration of the study and provide informed consent.

Exclusion Criteria:

* Individuals currently dealing with substance abuse issues.
* Individuals with active psychosis.
* Individuals currently experiencing high suicidality or deemed to be at a high risk of self-harm.
* Individuals currently undergoing a separate ED treatment.
* Individuals who have previously been exposed to the Purrble intervention.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale DERS-8
timeFrame: From enrollment to the end of intervention at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Kate Tchantura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slovak P, Ford BQ, Widen S, Dauden Roquet C, Theofanopoulou N, Gross JJ, Hankin B, Klasnja P. An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 9;10(11):e28914. doi: 10.2196/28914.
citation: Kinnaird E, Dandil Y, Li Z, Smith K, Pimblett C, Agbalaya R, Stewart C, Tchanturia K. Pragmatic Sensory Screening in Anorexia Nervosa and Associations with Autistic Traits. J Clin Med. 2020 Apr 20;9(4):1182. doi: 10.3390/jcm9041182.
citation: Brockmeyer T, Skunde M, Wu M, Bresslein E, Rudofsky G, Herzog W, Friederich HC. Difficulties in emotion regulation across the spectrum of eating disorders. Compr Psychiatry. 2014 Apr;55(3):565-71. doi: 10.1016/j.comppsych.2013.12.001. Epub 2013 Dec 7.
Clinical trial NCT01011881: Procalcitonin in Pleural Pleuritis
Official title: Evaluation de la Mesure du Taux de la Procalcitonine Dans Les Liquides Pleuraux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleuritis
Pleural Empyema
Keywords: pleuritis
empyema
procalcitonin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pleuritis

Brief summary: The purpose of this study is to determine pleural level of procalcitonin in differents situations of pleuritis.

Detailed description: Determine pleural level of procalcitonin in pleuritis. Two periods First period evaluation in vitro study/ Determine adequat technique included type of samples tubes for adequat analysis.

Second periods : Patient with pleuritis . Empyema or not

Eligibility criteria: Inclusion Criteria:

* Pleuritis
* Hospitalisation

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04815681: Evaluating an Online Wellness Intervention for Greek Adolescents
Official title: Evaluating an Online Single-session Intervention for Mental Health and Wellness of Greek Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Happiness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens, Greece
name: University Mental Health, Neurosciences and Precision Medicine Research Institute "Costas Stefanis," Greece
First posted: 2021-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, the investigators are conducting a randomized controlled trial with Greek adolescents attending high school in the Attica region in Greece. Students will be randomized to the COMET condition or to an active control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, subjective well-being) will be measured at two weeks post-intervention and four weeks post-intervention.

The investigators will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility criteria: Inclusion Criteria:

* Between 13 and 20 years old and a student at a participating Greek high school. Access to the internet.

Primary outcomes:
measure: Change in Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Up to 4 weeks post-intervention
measure: Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Up to 4 weeks post-intervention
measure: Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Up to 4 weeks post-intervention
Secondary outcomes:
measure: Ratings on the Acceptability of Intervention Measure (AIM)
timeFrame: Immediately after the intervention
measure: Ratings on the Intervention Appropriateness Measure (IAM)
timeFrame: Immediately after the intervention
measure: Secondary Control
timeFrame: Up to 4 weeks post-intervention
measure: Perceived Utility
timeFrame: Immediately after intervention
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Up to 4 weeks post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Athens
country: Greece
facility: Eginition Hospital National and Kapodistrian University of Athens School of Medicine
Study officials:
References:
Clinical trial NCT06691581: Italian Study for Congenital Platelet Disorders
Official title: Multicenter Observational Ambispective Study for Congenital Platelet Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Platelet Disorder
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with established diagnosis of inherited number or function platelet disorder (IPN and IPD, respectively), on the basis of internationally established clinical, laboratory and genetic criteria will be enrolled.

Brief summary: Inherited platelet disorders (IPD) are a heterogeneous group of rare bleeding diseases associated with a reduction of platelet number and/or function and with a bleeding tendency ranging from mild to severe. The frequency of inherited thrombocytopenias has been estimated to be 2.7/100,000 while the prevalence of inherited platelet function disorders is unknown, partly because they are frequently overlooked due to their difficult diagnosis.

Detailed description: This a no-profit national multicenter ambispectic (retrospective and prospective) observational study.

After collection of informed consent form each patient, each center will enroll the patient and will collect general, laboratory and clinical data on an electronic CRF on a REDCAP platform. Each patient will receive a unique identification number. All clinical events will be reported in the data base.

Eligibility criteria: Inclusion Criteria:

* All patients with established diagnosis of inherited number or function platelet disorder (IPN and IPD, respectively), on the basis of internationally established clinical, laboratory and genetic criteria will be enrolled.
* For patients \<18 ys, consensus will be signed by parents or legal responsible

Exclusion Criteria:

* No written consent
* Undocumented or uncertain diagnosis

Primary outcomes:
measure: congenital platelet diseases
timeFrame: 48 months
Secondary outcomes:
measure: QoL
timeFrame: 48 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS, Roma, Roma 00168
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Erica De Candia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786781: An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
Official title: An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoptysis
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 30
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: This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis


Eligibility criteria: Inclusion Criteria:

* Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure \< 90 mmHg), regardless of hemoptysis amount）

Exclusion Criteria:

* Pregnancy
* Patients with a previous history of bronchial artery embolization
* Uncorrectable severe infection, coagulation dysfunction, organ failure or cachexia, severe contrast agent allergy, and other interventional treatment contraindications

Primary outcomes:
measure: The accuracy rate of transarterial CT angiography in the identification of culprit vessel
timeFrame: Intraoperative phase
measure: In-hospital clinical success
timeFrame: During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge)
measure: Early hemoptysis recurrence rate
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Technical success rate
timeFrame: Intraoperative phase
measure: Radiation exposure
timeFrame: Intraoperative phase
measure: The amount of contrast agent consumed
timeFrame: Intraoperative phase
measure: Adverse events
timeFrame: Intraoperative phase and during 3 months after treatment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
References: