louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05558813: Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)
Official title: Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne
dystrophin
cardiomyopathy
cardiac MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 0
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

Detailed description: This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.

Eligibility criteria: Inclusion Criteria :

* Age \>= 6 years
* Genetically proven Duchenne muscular dystrophy
* Affiliation to French medical insurance
* Informed consent provided

Exclusion Criteria :

* Age \<6 years
* Left ventricular ejection fraction \<30%
* Tracheostomy of hospitalisation for acute respiratory failure \<1 year
* Contraindication to MRI: claustrophobia, Gadolinum allergy

Primary outcomes:
measure: Late gadolinium enhancement burden on cardiac MRI
timeFrame: 2 years
Secondary outcomes:
measure: Global T1 on cardiac MRI
timeFrame: 2 years
measure: Global T2 on cardiac MRI
timeFrame: 2 years
measure: Global extracellular volume on cardiac MRI
timeFrame: 2 years
measure: Left ventricular ejection fraction on cardiac MRI
timeFrame: 2 years
measure: Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI
timeFrame: 2 years
measure: Left ventricular systolic radial strain ejection fraction on cardiac MRI
timeFrame: 2 years
measure: Left ventricular systolic longitudinal strain on cardiac MRI
timeFrame: 2 years
measure: NTproBNP assay in the blood
timeFrame: 2 years
measure: Troponin I assay in the blood
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: APHP
name: Karim A WAHBI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01335113: A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Official title: A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinopathy of Prematurity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2011-04-14
Enrollment: 1
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: Premature newborns who are screened for retinopathy of prematurity at Stanford

Brief summary: The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.


Eligibility criteria: Inclusion Criteria:

* neonates being screened for retinopathy of prematurity

Exclusion Criteria:

* medically unstable neonates

Primary outcomes:
measure: axial length
timeFrame: one year
Secondary outcomes:
measure: anterior corneal curvature
timeFrame: one year
measure: wide angle fundus photography
timeFrame: one year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Stanford University
name: Darius M Moshfeghi, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Darius Moshfeghi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724113: ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Official title: Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shoulder Capsulitis
Keywords: Shoulder capsulitis
ARTHRO distension
Mobilisation
Randomised clinical trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 66
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 evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.

Detailed description: The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* shoulder capsulitis
* duration of symptoms ≥ 3 months
* health insurance

Exclusion Criteria:

* cognitive disorders
* Hypo coagulation
* biological inflammatory syndrome
* uncontrolled diabetes
* XYLOCAINE allergy
* pregnancy
* unable to understand and to speak french
* previous surgery of shoulder
* shoulder infiltration or distension in the previous month
* local contraindication to shoulder infiltration

Primary outcomes:
measure: Pain and disability using SPADI score at 2 weeks
timeFrame: at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Rheumatology department of Lariboisiere hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Johann Beaudreuil, PH MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120713: Noradrenergic Activity and Attention
Official title: The Influence of Noradrenergic Activity on Attentional Control in Younger and Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: attention
arousal
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults will be recruited from the student population at the University of Southern California. Older adults will be recruited from a volunteer registry.

Brief summary: Older adults demonstrate increased distractibility by task-irrelevant information which contributes to general cognitive impairment. However, it is yet unclear how changes in noradrenergic activity during aging influences attentional control. In the current study, tonic noradrenergic activity will be increased or decreased to investigate its behavioral and neural effects on attentional control.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Aged between 18-35 or 50-80
* Have normal or corrected-to-normal vision and hearing, and normal color vision
* Have a mobile phone and email address

Exclusion Criteria:

* Non-English speakers
* Currently practicing any relaxation, meditation, or breathing technique for more than an hour per week
* Have participated in studies measuring attentional capture in the past year
* Experiencing symptoms of dementia

Primary outcomes:
measure: Initial Eye-movements Toward Target and Distractor Shapes Measured by an Eye-tracker
timeFrame: Calculated once at the end of the 1 day experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Leonard Davis School of Gerontology
state: California
Study officials:
References:
Clinical trial NCT02507336: Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Official title: Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be followed until withdrawal of consent, or death.


Eligibility criteria: Inclusion Criteria:

1. Enrolled on the 20030165 clinical trial.
2. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).
2. Uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the PI to interfere with clinical study requirements.
3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to five years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to five years
measure: Response Rate (RR)
timeFrame: Up to five years
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: Up to five years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Izidore Lossos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalon MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. doi: 10.3109/10428190903518345.
Clinical trial NCT02567136: Imaging Biomarkers in ALS
Official title: A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Primary Lateral Sclerosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll ALS patients seeking care at the University of Minnesota and age-matched healthy control volunteers.

Brief summary: The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy controls.


Eligibility criteria: Inclusion Criteria:

* 21 to 75 years of age inclusive.
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

ALS patients:

* A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.

Exclusion Criteria:

* Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
* Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
* Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.
* The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.

Primary outcomes:
measure: Imaging biomarkers
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Walk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01685736: Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea
Official title: Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnoea
Hypertension
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to a sleep clinic

Brief summary: Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).


Eligibility criteria: Inclusion Criteria:

* Age ≤ 65 years
* Suspected OSA
* Treated or untreated for hypertension

Exclusion Criteria:

* History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke)
* History of asthma or chronic obstructive pulmonary disease (FEV1/FVC \<70%)
* History of diabetes mellitus, collagen diseases and sarcoidosis
* Serum creatinine \>1.6 mg/dl, proteinuria
* Previous treatment with CPAP
* Pregnancy or menstruation during the study
* Treatment with steroids, lithium or any other drugs affecting BP
* Change in antihypertensive treatment(if any) in the last 8 weeks before study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First University Department of Respiratory Medicine, Sotiria Hospital
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
References:
Clinical trial NCT01477736: A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Official title: A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Neurogenic bladder
Urodynamic
Quality of life
Lead sponsor: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 68
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 compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Spinal cord injury
* Detrusor overactivity
* Age over 18 years
* Spinal cord injury at least 12 months duration
* Undergoing regular clean intermittent catheterisation

Exclusion Criteria:

* Pregnancy
* Desire to become pregnant during the study period
* Breastfeeding
* Blood coagulation disorder
* Neuromuscular transmission disorder
* Use of any intravesical pharmacologic agents
* Previous use of botulinum toxin A

Primary outcomes:
measure: The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance
timeFrame: Beginning and 24 weeks of the study
Secondary outcomes:
measure: The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
timeFrame: Beginning and 24 weeks of the study
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: UNICAMP, Division of Urology
state: Sao Paulo
Study officials:
affiliation: Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo
name: RUITER S FERREIRA, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karsenty G, Denys P, Amarenco G, De Seze M, Game X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. doi: 10.1016/j.eururo.2007.10.013. Epub 2007 Oct 16.
Clinical trial NCT02818036: An fMRI Study of Opioid-related Changes in Neural Activity
Official title: An fMRI Study of Opioid-related Changes in Neural Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Acceptance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.


Eligibility criteria: Inclusion Criteria:

* good health
* between the ages of 18 and 35,
* fluent in English
* right-handed (for the fMRI scan)

Exclusion Criteria:

* Self-reported current or past diagnoses of physical or mental illness.
* Score on the Patient Health Questionnaire (depressive symptoms) above a 13
* Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
* Positive urine pregnancy test
* Use of any prescription medication, except for birth control
* Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
* Self-reported problems with liver functioning, including hepatitis or liver failure
* Difficulty swallowing or taking pills
* BMI greater than 35 or weight greater than 400 lbs
* Claustrophobia
* Nonremovable metal in the body

Primary outcomes:
measure: Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
timeFrame: approximately one hour after taking study drug
measure: Self-reported Feelings of Connection in Response to the Scanner Tasks
timeFrame: approximately two hours after taking study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Ross LP, Andreescu C, Inagaki TK. Relationships Between Early Maternal Warmth and Social Connection: A Randomized Clinical Trial With Naltrexone. Psychosom Med. 2021 Oct 1;83(8):924-931. doi: 10.1097/PSY.0000000000000986.
citation: Inagaki TK, Hazlett LI, Andreescu C. Opioids and social bonding: Effect of naltrexone on feelings of social connection and ventral striatum activity to close others. J Exp Psychol Gen. 2020 Apr;149(4):732-745. doi: 10.1037/xge0000674. Epub 2019 Aug 15.
Clinical trial NCT04511936: Microcurrent Stimulation for Dry Age-related Macular Degeneration
Official title: Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dry Age-related Macular Degeneration
Keywords: AMD
Dry AMD
Lead sponsor: i-Lumen Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

Detailed description: Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Eligibility criteria: Key Inclusion Criteria - Study Eye:

* Dry AMD diagnosis.

Key Exclusion Criteria - Study Eye:

* Wet AMD

Primary outcomes:
measure: Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.
timeFrame: 1 Month
Secondary outcomes:
measure: Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.
timeFrame: 1 Month
Other outcomes:
Locations:
Study officials:
affiliation: King's College London
name: Timothy Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: