louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04359940: Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot
Official title: The Effect of Different Contouring Techniques on Cardiac Magnetic Resonance Assessment of Right Ventricular Volumes in Repaired Tetraology of Fallot: Implications on Preoperative Thresholds for Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tetralogy of Fallot
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with repaired tetralogy of Fallot (RTOF) with chronic pulmonary regurgitation who require monitoring for right ventricular dilatation.

Brief summary: Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

Detailed description: Participants with repaired tetralogy of Fallot (RTOF) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. Cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. There are different post-processing techniques published for measuring RV volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). The primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative RV volumetric thresholds for intervention. As a secondary aim, the investigators will determine the reproducibility of different contouring methods.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with repaired Tetralogy of Fallot undergoing routine clinical surveillance at a Level 1 ACHD surgical referral centre.

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique
timeFrame: Cross-sectional study. Repeated measurements performed on the baseline CMR study.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: QEHB
city: Birmingham
country: United Kingdom
facility: Cardiac MRI department, University Hospitals Birmingham NHS Foundation Trust
Study officials:
affiliation: UHB
name: William Moody
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03843840: Dual Wavelength OCT
Official title: Combined Coaxial Optical Coherence Tomography System to Image the Retina and Choroidal Structures and Estimate Tissue Reflectivity in Healthy and Diseased Retinas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMD
Diabetic Retinopathy
Retinal Degeneration
Retinal Dystrophies
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with diseased retina

Brief summary: The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.

Detailed description: Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.

Eligibility criteria: Inclusion Criteria:

* Age\>18
* Ability to consent
* Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
* clinical care

Exclusion Criteria:

* Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
* the retina and/or choroidal substructures in the opinion of the investigator
* Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.

Primary outcomes:
measure: Test retest reliability
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
Study officials:
References:
Clinical trial NCT01330940: Effect of Diet Orange Soda on Urinary Lithogenicity
Official title: Effect of Diet Orange Soda on Urinary Lithogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stones
Nephrolithiasis
Urolithiasis
Keywords: Kidney stones
Calcium
citrate
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2011-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.

Detailed description: The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* able to sign consent
* ability to reliably urinate into a vessel and measure urine volume

Exclusion Criteria:

* prior history of nephrolithiasis
* a known history of metabolic bone disease
* hyperthyroidism
* hyperparathyroidism or chronic kidney disease
* current use of diuretics
* current use of potassium citrate or other oral alkali supplementation and
* use of calcium supplementation that could not be stopped

Primary outcomes:
measure: Change in urine citrate content
timeFrame: 1 week
Secondary outcomes:
measure: Change in urine pH
timeFrame: One week
Other outcomes:
Locations:
city: New York City
country: United States
facility: New York Harbor VA Medical Center
state: New York
Study officials:
affiliation: New York Harbor VA Medical Center
name: David S Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01323140: Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Official title: An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Keywords: hypogonadism, testosterone, transdermal system
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 40
Sex: MALE
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: Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

Detailed description: The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

Eligibility criteria: Inclusion Criteria:

* Male, 18 - 65 years of age;
* Documented testosterone deficiency;
* BMI 18 to 33.

Exclusion Criteria:

* Evidence of prostate cancer and benign prostate hyperplasia;
* Taking medications that interfere testosterone metabolism;
* History of alcohol or drug substance abuse;
* Abnormal ECG;
* Allergic to transdermal products;
* Skin condition that interfere transdermal system application and assessment

Primary outcomes:
measure: Percent of Subjects With Testosterone Levels in the Normal Range.
timeFrame: Day 29/30
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Meyers
country: United States
facility: Watson Investigational Site
state: Florida
city: Tacoma
country: United States
facility: Watson Investigational Site
state: Washington
Study officials:
affiliation: Watson Pharmaceuticals
name: Keshava Kumar, PhD, MHSA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01304940: Women's Post Traumatic Stress Disorder (PTSD) Research Study
Official title: The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posttraumatic Stress Disorder
Keywords: Stress
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
name: Boston VA Research Institute, Inc.
name: Boston University
First posted: 2011-02-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, ages 18-55.

Brief summary: The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.

Detailed description: The investigators are trying to understand if there is a relationship between the experience of traumatic events such as those experienced by people with post traumatic stress disorder and reactivity to startling noises or mild threats. So, the investigators are looking at startle reflex, heart rate, and stress hormone responses to short noises and small shocks in people exposed to trauma and who either do or do not have PTSD. Additionally, the investigators will be looking at how the menstrual cycle impacts these processes. The investigators know that women have twice the risk for developing PTSD and some research suggests that stress hormones change during the menstrual cycle and may have an effect on risk.

Eligibility criteria: Inclusion Criteria:

* Women, ages 18-55 years old who have a regular menstrual cycle and who can come in to participate in the afternoon

Exclusion Criteria:

* Long-term medications, oral or steroid contraceptives, irregular menstrual cycle

Primary outcomes:
measure: Prepulse Inhibition
timeFrame: This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Suzanne Pineles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03157440: Novel Device for Screening Patients With Symptoms of OSA
Official title: Validation of a Novel Device for Screening Patients With Symptoms of OSA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 symptoms of OSA who will be undergoing sleep study for establishing a diagnosis

Brief summary: An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA


Eligibility criteria: Inclusion Criteria:

* Patients above 18 years old and below 70 years old, both men and women

Exclusion Criteria:

* Patients requiring oxygen therapy or noninvasive ventilation;
* Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy.
* Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.

Primary outcomes:
measure: the concordance of the ring oximetry with PSG as the gold standard
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT05921240: Unmet Needs, Barriers and Facilitators to Vision Services for Children and Adolescents With Special Vision Care Needs: A Mixed-Model Design Study
Official title: Special Needs (Vision)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vision Disorders
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 330
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents, educators, and profession with experience in children and adolescents with special needs in vision

Brief summary: Children and adolescents with special needs, compared to those with general development, have a much higher incidence of visual impairments (10.5% vs. 0.16%). This project will focus on "children and adolescents with special visual care needs", comprehensively exploring their unmet needs in ophthalmology and visual care, as well as the obstacles and facilitators they may encounter in the process of seeking ophthalmic services.

The purposes of this study will investigate the current needs of children and adolescents with special visual care needs in ophthalmology and visual medical services, and the obstacles and potential facilitators encountered by children and adolescents with special visual care needs in the process of obtaining ophthalmology and visual medical services.

Detailed description: The research will center on children and adolescents with special visual needs and explore the research questions from various stakeholders' perspectives, including parents, special education teachers and experts, healthcare professionals, workers from related NGOs and government units. A mixed-methods research approach will be used to gather both quantitative and qualitative data. After data analysis, a comparison and interpretation between the two results will be conducted to obtain the final research outcomes.

1. Quantitative research: Two-part questionnaire. The first part collects background information, and the second part is a "Needs and Difficulties Survey", framed by Levesque et al.'s conceptual framework of access to healthcare.
2. Qualitative research: The first part consists of semi-structured in-depth interviews, and the second part uses the focus group method. Both parts will use a common interview guideline and the International Classification of Functioning, Disability and Health, Child \& Youth Version (ICF-CY) as the theoretical framework.

Eligibility criteria: Inclusion Criteria:

1. Able to read, understand, and fill out questionnaires in Chinese
2. Able to conduct interviews in Chinese

Exclusion Criteria:

1. The special needs children or adolescents they have taught do not have specific visual needs, hence they cannot provide relevant information.

Primary outcomes:
measure: qualitative data analysis
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00877240: The Influence of an Intervention Program on Altering Health Behavioral Patterns Among IDF's Staff
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Physical Fitness Habits
Balanced Nutrition
Weight Reduction
Smoking Cessation
Reduction of Stress
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 26
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this study is to determine the effectiveness of a general intervention that includes encouragement of physical activity and healthy living habits of officers and permanent staff in the IDF


Eligibility criteria: Inclusion Criteria:

* IDF'S staff member
* Age \>26
* One or more risk factor

Exclusion Criteria:

* Cardio vascular condition
* Respiratory disease
* Other healthy conditions according to the physician's decision

Primary outcomes:
measure: physical fitness habits weight reduction balanced nutrition
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: IDF's Medical Corps
Study officials:
References:
Clinical trial NCT00259740: Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Official title: An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 96
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: The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

Detailed description: Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* clinical diagnosis of relapsed or plateau-phase multiple myeloma
* measurable disease (\>0.5 g/dL) as determined by special blood tests
* ECOG 0 or 1

Exclusion Criteria:

* newly diagnosed myeloma
* non-secretory myeloma
* plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
* prior allogeneic stem cell transplant
* administration of oral or IV bisphosphonates within 2 weeks of enrollment to study

Other criteria also apply.

Primary outcomes:
measure: Complete Response or Partial Response Based on M-Protein Assessments Only
timeFrame: Up to 18 months
Secondary outcomes:
measure: Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
timeFrame: Up to 18 months
measure: Complete Response Based on M-Protein Assessments Only
timeFrame: Up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Vij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509.
Clinical trial NCT06222840: Electro-clinical Features and Functional Connectivity Analysis in SYN1 Gene Mutation-related Epilepsy
Official title: Electro-clinical Features and Functional Connectivity Analysis in SYN1 Gene Mutation-related Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epileptic Syndromes
Keywords: SYN1 mutation
reflex bathing epilepsy
neurodevelopmental disorders
connectivity analysis
electro-encephalographic seizure pattern
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SYN1 gene mutation patients and controls

Brief summary: SYN1 gene mutation is an X-linked gene mutation that causes numerous pathological manifestations such as seizures and neurodevelopmental disorders. A few descriptions of this disease have been published in the last decade, but the electro-clinical features of epilepsy are still largely unknown. No analysis of electroencephalographic connectivity has yet been performed. The aim of this study is to perform a detailed electro-clinical seizure analysis and electroencephalographic analysis in patients with a SYN1 gene mutation, in an attempt to identify a characteristic pattern that would allow earlier diagnosis and better understanding and management of this disease.


Eligibility criteria: Inclusion Criteria:

* Cases : SYN1 gene mutation, available electroencephalographic and clinical data.
* Controls : older than 12 years at the moment of the electroencephalogram recording, electroencephalogram considered as normal, no neurological disease (particularly no epilepsy), no neuroimaging abnormality.

Exclusion Criteria:

- Controls : younger than 12 years at the moment of the electroencephalogram recording, electroencephalogram considered as abnormal, neurological disease (particularly epilepsy), neuroimaging abnormality.

Primary outcomes:
measure: Electroencephalographic functional connectivity mapping
timeFrame: Month 6
Secondary outcomes:
measure: Electroencephalographic reading grid
timeFrame: Month 6
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Laure MAZZOLA, MD
role: PRINCIPAL_INVESTIGATOR
References: