louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064973: An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
Official title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Keywords: autism
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.


Eligibility criteria: Inclusion Criteria:

* Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator

Exclusion Criteria:

* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension

Primary outcomes:
measure: Irritability subscale of the Aberrant Behavior Checklist
timeFrame: every 2 to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research & Resource Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina Neurosciences Hospital
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
city: Houston
country: United States
facility: Red Oaks Psychiatry Associates, P.A.
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT06944873: Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases
Official title: Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Monocytes
Metabolic reprogramming
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institute for Advanced Biosciences (IAB), Grenoble
First posted: 2025-04-25
Enrollment: 30
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 IBD in severe relapse requiring hospitalisation for immunosuppressive therapy or endoscopy for relapse.

Brief summary: Inflammatory bowel diseases, Crohn's disease and haemorrhagic rectocolitis, are pathologies that progress in flare-ups, impacting on patients' quality of life and functional or even vital prognosis. These inflammatory diseases require the use of immunosuppressive and immunomodulatory treatments, the side-effects of which can be significant, and the limited number of which sometimes puts patients and practitioners in a therapeutic impasse from which surgery is the only way out. It is therefore important to be able to develop new therapeutic approaches, ideally better tolerated, that can control inflammation during relapses. Monocytes are one of the main players in the inflammatory reaction. In the laboratory, we have developed a strategy for the metabolic reprogramming of these cells based on the use of oxygen microbubbles to modulate the inflammatory response of monocytes.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18
* Managed at the CHUGA for a severe IBD flare-up requiring hospitalisation or endoscopy for flare-up
* Patient not objecting to the REPRO-MICI study

Exclusion Criteria:

* Patients protected by law (pregnant or breast-feeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalised under duress).
* Patients with positive HIV, HBV or HCV serology.
* Patients with a positive ELISPOT with no history of treatment for latent tuberculosis.

Primary outcomes:
measure: Comparaison of reduction of concentration of inflammatory cytokines and chemokines in cells treated by oxygen microbubbles vs cells not treated
timeFrame: up to 2 years
Secondary outcomes:
measure: Comparaison of tissue factor expression at the membrane of monocytes treated by microbubbles vs monocytes not treated
timeFrame: up to 2 years
measure: Comparaison of glucose metabolism rate in monocytes treated bu microbubbles vs not treated cells
timeFrame: up to 2 years
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Marianne HUPE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758973: Validity and Reliability of the Turkish Version of the 4-Item Short Form of the Pain Anxiety Symptom Scale
Official title: Validity and Reliability of the Turkish Version of the 4-Item Short Form of the PASS
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Scale Reliability Validity
Keywords: pain
anxiety
reliability
validity
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be implemented at the Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center between the dates after receiving the ethics committee approval. Patients who apply to the Physical Medicine and Rehabilitation Polyclinic with complaints of pain will be examined by a physical therapist. Patients who are diagnosed with chronic pain through physical examination, meet the inclusion criteria and agree to participate in the study will be included in the study.

Brief summary: The primary aim of the study was to determine the reliability and validity of the Turkish version of the 4-Item Short Form of the Pain Anxiety Symptom Scale. The secondary aim of the study was to determine the level of pain-related anxiety in individuals with chronic pain.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18-65
2. Having pain 4 or more days a week
3. Having weekly pain intensity of 3 or more according to the Numeric Pain Rating Scale
4. Having chronic pain lasting at least 3 months
5. Being able to read and write and having no cognitive problems
6. Individuals who volunteer to participate in the study will be included.

Exclusion Criteria:

1. Having pain limited to headache only

Primary outcomes:
measure: Pain Anxiety Symptom Scale 4-Item Short Form
timeFrame: 20 weeks
Secondary outcomes:
measure: Chronic Pain Admission Form
timeFrame: 20 weeks
measure: Beck Anxiety Inventory
timeFrame: 20 weeks
measure: Visual Analog Scale
timeFrame: 20 weeks
measure: Chronic Pain Acceptance Questionnaire
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
Study officials:
References:
Clinical trial NCT01391273: Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Official title: A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyelash Prominence in Japanese Subjects With Hypotrichosis of the Eyelashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 173
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.


Eligibility criteria: Inclusion Criteria:

* Have inadequate eyelashes

Exclusion Criteria:

* Any disease/infection/abnormality of the eye or area around the eye
* Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
* Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
* Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
* Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
* Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months

Primary outcomes:
measure: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Eyelash Thickness as Measured by DIA
timeFrame: Baseline, Month 4
measure: Change From Baseline in Eyelash Darkness as Measured by DIA
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.
Clinical trial NCT06745973: An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B
Official title: An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Epigenic Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, 2-Part (Single Ascending Dose \[Part 1\] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself.


Eligibility criteria: Inclusion Criteria:

1. Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
2. Confirmed diagnosis of CHB;
3. Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study

Exclusion Criteria:

1. Confirmed diagnosis of liver cancer or cirrhosis;
2. Combination of other major diseases; 3 Pregnant or lactating females.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs
timeFrame: From Baseline through to Day 28 postdose
Secondary outcomes:
measure: Evaluation of maximum observed concentration (Cmax)
timeFrame: From Baseline through to Day 28 postdose
measure: Evaluation of maximum observed concentration (tmax)
timeFrame: From Baseline through to Day 28 postdose
measure: Evaluation of terminal elimination half-life (t1/2)
timeFrame: From Baseline through to Day 28 postdose
measure: HBsAg
timeFrame: From Baseline through to Day 365 postdose
Other outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
timeFrame: From Baseline through to Day 365 postdose
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT03902873: The Effect of a Real-time Audiovisual Feedback System on CPR Quality
Official title: The Effect of a Real-time Audiovisual Feedback System on CPR Quality During In-hospital Cardiac Arrest: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The investigators will evaluate the effect of a real-time audiovisual feedback system on CPR quality during in-hospital cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* Patients over 17 years old who require cardiopulmonary resuscitation in a medical or surgical intensive care units

Exclusion Criteria:

* Patients less than 18 years
* Patients with Do Not Resuscitate order
* Patients who require cardiopulmonary resuscitation outside a medical or surgical intensive care unit

Primary outcomes:
measure: chest compression fraction
timeFrame: 2 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Agree
Study officials:
affiliation: Seoul National University Hospital
name: Ho Geol Ryu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108573: Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters
Official title: Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-04-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a definite diagnosis of multiple sclerosis, with a follow-up MRI

Brief summary: This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence

Detailed description: MRI is a tool of choice for detecting demyelinating lesions in Multiple Sclerosis (MS) disease. On a consensual basis, the detection of those lesions in done on FLAIR (FLuid Attenuated Inversion Recovery) sequences, weighted T2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. The environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. Keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of FLAIR. Although 3D FLAIR sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis.

The aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.

Eligibility criteria: Inclusion Criteria:

* relapsing remitting multiple sclerosis
* MRI required

Exclusion Criteria:

* MRI contraindication

Primary outcomes:
measure: Number of detectable lesions
timeFrame: baseline
Secondary outcomes:
measure: localisation of lesions
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02934373: Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Official title: Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System


Eligibility criteria: Inclusion Criteria:

1. 12 months old or older
2. Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
3. Use of the CP810, CP920 or CP910 sound processor
4. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
3. Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device

Primary outcomes:
measure: Subjective rating with a new sound processor compared to ratings with each subjects own processor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SINT-Augustinus Antwerpen
state: Wilrijk
city: Southampton
country: United Kingdom
facility: University of Southampton - Auditory Implant Service Highfield
state: Hampshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals - Queens Medical Centre
state: Nottinghamshire
Study officials:
affiliation: Head of Clinical Affairs
name: Mary Beth Brinson
role: STUDY_CHAIR
References:
Clinical trial NCT00369473: Long-Term Assessment of Safety and Physical Function With AMG 108 in RA
Official title: A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 690
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 purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA


Eligibility criteria: Inclusion Criteria:

* Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.

Exclusion Criteria:

* Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

Primary outcomes:
measure: To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168
timeFrame: 144 Weeks
Secondary outcomes:
measure: To determine whether long-term use of AMG 108 improves function in subjects with RA
timeFrame: 144 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04142073: CCU Wireless Vital Signs Monitoring
Official title: Advanced Wireless and Wearable Sensors for Patients With Critical Neonatal and Pediatric Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CCU Inpatients
Keywords: wireless vitals
vitals monitor
cardiac
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2019-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate

Brief summary: This is a pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals

Detailed description: This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital to test a wireless vitals monitor against the current vitals monitors used in the Cardiac Care Unit.

Eligibility criteria: Inclusion Criteria:

* Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate

Exclusion Criteria:

* Patients at imminent risk of death
* Patients with a skin abnormality that precludes assessment
* Patients with hyperbilirubinemia and requiring a need for UV light

Primary outcomes:
measure: Percent agreement with pilot sensor and current standard of vital signs monitoring
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephanie Rangel
role: STUDY_DIRECTOR
References: