louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01299961: Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
Official title: Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Subcutaneous Abatacept
Ultrasound
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.

The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.


Eligibility criteria: Inclusion Criteria:

1. Over 18 years old
2. Has a diagnosis of rheumatoid arthritis
3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
4. Disease activity score DAS28/ESR \> 3.2 or all must be met: TJC (tender joint count)\>=4, SJC (swollen joint count)\>=4
5. Must be able to understand information in the Informed Consent and comply with study requirements
6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score \>=1 for at least 2 joints and total synovitis score \>=1 for at least 1 joint

Exclusion Criteria:

1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
2. Pregnancy or breast feeding
3. Daily prednisone \> 10mg (stable dose for at least 1 month)
4. Intra-articular steroid injection of the wrist or joints within last 2 months
5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
6. History of cancer
7. Previous exposure to abatacept

Primary outcomes:
measure: 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
timeFrame: baseline, 12 months
Secondary outcomes:
measure: 12 Month Change in Power Doppler Ultrasound (PDUS) Scores
timeFrame: baseline, 12 months
measure: 12 Month Change in Gray-scale Ultrasound (GSUS)
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine, Division of Rheumatology
state: California
Study officials:
affiliation: UCLA David Geffen School of Medicine, Division of Rheumatology
name: Veena K Ranganath, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861561: Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children
Official title: Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Insufficiency
Infection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 43
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Although severe infection is the significant complication related to poorer prognosis for juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable with obtained high-dose regimen. There was lower number of severe infection episodes, but no significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of serious infection and improve overall patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Child up to 15 years of age who fulfilled the 1997 updating the American College of Rheumatology revised criteria for the classification of SLE and his or her renal biopsy reveals lupus nephritis class III or IV regarding to International Society of Nephrology/Renal Pathology Society revision on the classification of the lupus nephritis.

Exclusion Criteria:

* patient who has prior renal insufficiency due to chronic kidney disease other than lupus nephritis
* patient who has the history of cyclophosphamide hypersensitivity
* patient who has prior cyclophosphamide or mycophenolate mofetil administration within 6 months
* patient who is pregnant

Primary outcomes:
measure: renal response
timeFrame: at 6 months of the treatment
Secondary outcomes:
measure: infection
timeFrame: within 6 months
Other outcomes:
measure: Patient well being
timeFrame: at 0,1,3 and 6 months of the treatment
measure: SLE disease activity index score
timeFrame: at 0,1,3 and 6 months of the treatment
Locations:
city: Bangkoknoi
country: Thailand
facility: Nephrology division, Department of Pediatrics, Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Nuntawan Piyaphanee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siriraj Hospital
name: Anirut Pattaragarn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02856061: Tracking Intervention Effects With Eye Tracking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Simons Foundation
First posted: 2016-08-04
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot study examines concurrent and predictive relationships between eye tracking and clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking system) as well as home-based measures (using tablet-based eye tracking systems). The major goals of this study are both to improve our understanding of the potential role of eye tracking in clinical trials and to advance technologies that may further improve the sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.


Eligibility criteria: Inclusion Criteria:

* Individuals ages 4-7 years diagnosed previously with ASD and meet criteria for ASD when characterized by our research team, English is a language spoken in the family, and Full-scale IQ\>50. Participants must also complete laboratory and home-based eye tracking sessions, with success determined by the Principal Investigator.

Exclusion Criteria:

* Individuals will be excluded from participation based on the presence of

  1. a physical or neurological disorder (e.g., cerebral palsy) which is likely to impact development and learning, as intervention procedures for these individuals may need to be modified beyond the standard approach to address more complex developmental needs,
  2. hearing loss or other severe sensory impairment,
  3. history of significant head trauma or serious brain or psychiatric illness,
  4. parents/caregivers who do not speak fluent English,
  5. parents/caregivers who have previous training in PRT
  6. individuals who must be excluded from eye tracking. These families will be offered the treatment clinically (i.e., fee-based), and they will be given referrals to outside agencies offering the treatment as well.

Primary outcomes:
measure: Laboratory Eye Tracking Measuring Longitudinal Change
timeFrame: 16 Weeks
measure: Home-Based Eye Tracking
timeFrame: 16 Weeks
measure: Longitudinal Change in Autism Symptom Severity
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Shic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Pamela Ventola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554461: Optimization of Movement Patterns in Elite Volleyball Players
Official title: Optimaliseren Van Lichaams- en Bewegingsspecifieke Kenmerken Bij Volleybalspelers Met Het Oog op Het Reduceren Van Blessures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optimisation of Performance and Avoidance of Injury
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female national team volleyball players

Brief summary: On the basis of clinical and movement analysis records players are informed on what parameters can be optimized in order to improve their performance and avoid injuries


Eligibility criteria: Inclusion Criteria:

Members of national volleyball team signing informed consent

Exclusion Criteria:

No specific exclusion criteria

Primary outcomes:
measure: 2D and 3D joint angles of different movements together with kinetics
timeFrame: 1 day
Secondary outcomes:
measure: muscle strength
timeFrame: 1 day
measure: muscle strength
timeFrame: 1 day
measure: joint stability
timeFrame: 1 day
measure: joint control
timeFrame: 1 day
measure: prevalence injury past
timeFrame: 1 day
measure: prevalence injury present
timeFrame: 1 day
measure: (segmental) length
timeFrame: 1 day
measure: weight
timeFrame: 1 day
measure: Body mass index
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: UZLeuven - KU Leuven
name: Filip f Staes, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03303261: Study On Discopathie With Modic 1
Official title: Study On Discopathie With Modic 1
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Hernia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient hospitalized in GHPSJ for infiltration

Brief summary: The chronic lumbago can be associated with an active discopathie, objectified on the MRI by the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing the pathological vertebral disk The treatment recommended by t consists in particular of a local infiltration of corticoids which the efficiency is variable according to the patients. The objective of this study is to estimate the efficiency of the local treatment and to highlight some of the factors associated to the advantage of the infiltration by corticoids.


Eligibility criteria: Inclusion Criteria:

* Patient admitted in Rhumatology service for intra-disc infiltration
* Chronic pain (\>3 monts)
* VAS \>3
* MRI stipulating MODIC 1

Exclusion Criteria:

* radiculalgy
* radicular VAS\< lumbar VAS
* pregnancy
* local infection
* corticoid allergy
* previous rachial surgery
* previous spondylodiscite
* psychiatric disorder
* MRI contraindication

Primary outcomes:
measure: pain VAS ( VISUAL ANALOGIC SCORE)
timeFrame: Day 1 - Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: COHEN SOLAL P Julien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01543061: Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Official title: Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contact Lens Related Dry Eye Syndrome
Lead sponsor: Optometric Technology Group Ltd
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2012-03-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.


Eligibility criteria: Inclusion criteria:

* Current silicone hydrogel contact lens wearer
* Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria:

* Known allergy or sensitivity to the study product(s) or its components
* Systemic or ocular allergies
* Use of systemic medication which might have ocular side effects.
* Any ocular infection.
* Use of ocular medication.
* Significant ocular tissue anomaly

Primary outcomes:
measure: Tear Break up Time
timeFrame: 30 days
Secondary outcomes:
measure: Conjunctival staining measurement
timeFrame: 30 days
measure: Tear film evaporation rate
timeFrame: 30 days
measure: Ocular Surface Disease Index questionnaire
timeFrame: 30 days
measure: Comfort, vision and ocular symptoms questionnaire
timeFrame: 30 days
measure: Post wear contact lens deposition and lipid uptake assessment
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: OTG Research & Consultancy
Study officials:
affiliation: Optometric Technology Group Ltd
name: Michel Guillon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785161: Penumbra Imaging Collaborative Study (PICS)
Official title: Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Penumbra System
Mechanical Thrombectomy
Ischemic Stroke
Intervention
Neurovascular
Thrombus
Imaging
Ischemic Penumbra
Functional Outcome
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 289
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: A stroke cohort who were revacularized by the Penumbra System

Brief summary: The primary aim of this study are to gather data on the "real world" experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.


Eligibility criteria: Inclusion Criteria:

* All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.

Primary outcomes:
measure: Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.
timeFrame: Admission
measure: Proportion of patients with successful revascularization of the occluded target vessel as defined by a TIMI score of 2 or 3 following use of the Penumbra System.
timeFrame: Post-Procedure
measure: The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.
timeFrame: 90-Days Post-Procedure
Secondary outcomes:
measure: Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.
timeFrame: Admission and Discharge
measure: Incidence of intracranial hemorrhage.
timeFrame: 24-Hours Post-Procedure
measure: Incidence of device-related serious adverse events.
timeFrame: During the Procedure
measure: All cause mortality at 90 days post-procedure.
timeFrame: 90-Days Post-Procedure
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
Study officials:
affiliation: Penumbra Inc.
name: Siu Po Sit, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005361: Determinants of Respiratory Health in Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To measure lung function and respiratory symptom status in a large cohort of healthy, non-smoking 18-22 year old subjects, and relate these measurements to past histories of passive smoke and air pollution exposures.

Detailed description: BACKGROUND:

While the natural history of human lung function growth and decline has been studied intensively over the past 30 years, relatively few data have been collected during the period in which peak volumetric function is achieved, i.e., around the age of 20. As a result, very little is known about the factors, both demographic and environmental, which influence maximal attained lung function.

DESIGN NARRATIVE:

The longitudinal study collected information on the history of respiratory illness, residential history, parental smoking, socio-economic status and home characteristics via an initial questionnaire administered to cadets enrolling at West Point. A sequence of four annual measurements of lung function (by spirometry), and prior-year respiratory health status and activity patterns was obtained in the spring of each year. Pollution exposures were estimated by matching residential histories with historical pollution data stored at the Environmental Protection Agency. Data on meteorological variables (temperature, relative humidity, wind speed) and altitude were obtained for each residential location. The four annual lung function measurements provided precise estimates of individual mean levels of FVC, FEV1, FEF25-75, PEFR, and flow rates at 50 percent and 75 percent of expired FVC. Subject-specific lung function level was analyzed in relation to history of parental smoking and prior exposure to air pollution using analysis of variance methods, controlling for potential confounding variables. In addition to testing these hypotheses regarding the respiratory effects of passive smoking and air pollution exposure, the study also explored the effects of these exposures on the change in lung function between the ages of 18 and 22 and on respiratory illness and symptom experience while at West Point. Finally, the study established a cohort which could be followed in future years.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kinney PL, Nilsen DM, Lippmann M, Brescia M, Gordon T, McGovern T, El-Fawal H, Devlin RB, Rom WN. Biomarkers of lung inflammation in recreational joggers exposed to ozone. Am J Respir Crit Care Med. 1996 Nov;154(5):1430-5. doi: 10.1164/ajrccm.154.5.8912760.
Clinical trial NCT05423561: Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
Official title: Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pseudoarthrosis of Bone
Implant Breakage
Keywords: hypertrophic pseudarthrosis
dynamization
corticalisation
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 12
Sex: ALL
Minimum age (years): 28
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.

Detailed description: Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.

Eligibility criteria: Inclusion Criteria:

* Subtrochanteric fractures
* Nonunion with Pain

Exclusion Criteria:

* Infection
* Pathological Fracture (Tumor)

Primary outcomes:
measure: Provide Bone Union
timeFrame: 6 months
measure: Relieving pain in the nonunion area
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: