louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04195789: Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound
Official title: Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Lung Diseases, Interstitial
Rheumatoid Arthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 34
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 followed for a rheumatoid arthritis

Brief summary: The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.

Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.

The investigators want to assess the lung ultrasound performance compared with the gold standard.

Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.


Eligibility criteria: Inclusion Criteria:

* Men and women over the age of 18
* With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
* Never received any biotherapy or targeted therapy
* Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)

Exclusion Criteria:

* Refusal to participate in the study
* Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
* Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
* Patient with signs of cardiac decompensation
* Patient with pulmonary auscultation suggestive of PID
* Pregnant or lactating woman
* Psychiatric pathology seriously hindering understanding
* Difficulty understanding oral French
* Person deprived of liberty or under legal protection

Primary outcomes:
measure: Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310
Study officials:
References:
Clinical trial NCT04008589: Non-invasive Current Stimulation for Restoration of Vision
Official title: Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Electrical Stimulation
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: ERA-NET
First posted: 2019-07-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.


Eligibility criteria: Inclusion Criteria:

* HH due to ischemic or hemorrhagic stroke
* age between 18 and 75 years
* lesion age at least 6 months
* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
* best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

* known active malignancy
* eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
* electric or electronic implants (e.g. heart pacemaker)
* metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
* expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
* epileptic seizure within the last 10 years
* use of antiepileptic or sedative drugs

Primary outcomes:
measure: Size of the visual field
timeFrame: 2 weeks
Secondary outcomes:
measure: Resting EEG power spectra
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Institute of Medical Psychology
Study officials:
References:
Clinical trial NCT05822089: Intraindividual Comparison of EMO IOLs
Official title: Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age Related Cataracts
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 311
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual comparison of 7 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.
Primary purpose: TREATMENT

Brief summary: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
* Age 50 to 100
* Visual potential in both eyes of 20/25 or better as determined by investigators estimation
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)

Exclusion Criteria:

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
* Pupil diameter \< 2.0 mm (photopic)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Pregnancy/Nursing
* childbearing ability

Primary outcomes:
measure: Distant corrected intermediate visual acuity
timeFrame: 2-6 months
measure: Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL
timeFrame: 3-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christina Leydolt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05096689: Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures
Official title: Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Humerus
Physeal Fracture
Lead sponsor: Children's Fractures Interest Group, Denmark
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Cohort, Single center
Primary purpose: TREATMENT

Brief summary: The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.

Detailed description: The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute Lateral humeral condyle fracture
* Fracture \<5 days old
* Fracture with \<5 mm of displacement on plain radiographs
* Parental informed consent obtained

Exclusion Criteria:

* Contraindication(s) to performing an MRI
* Unable to participate in follow-up
* Existing bone pathology
* Previous ipsilateral elbow fracture

Primary outcomes:
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: 2 years
Secondary outcomes:
measure: MRI results
timeFrame: 2 weeks
measure: Radiographic results
timeFrame: 2 years
measure: Secondary fracture displacement
timeFrame: 2 years
measure: Pain scale (age <5 years)
timeFrame: 2 years
measure: Pain scale (age >4 years)
timeFrame: 2 years
measure: Pain scale (age >8 years)
timeFrame: 2 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev and Gentofte
state: Capital Region
Study officials:
name: Morten J Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050889: Mechanisms of Exercise-Induced Hypoalgesia
Official title: Mechanisms of Exercise-Induced Hypoalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise-Induced Hypoalgesia (EIH) is a lessening of pain sensitivity in response to an acute bout of exercise. Limited research has examined the effects of expectations on EIH during a dynamic resistance training during different intensities. Therefore, the purpose of this study is to examine the effects of positive and negative expectations on EIH.

Detailed description: Individuals who meet the eligibility criteria and consent to participate will attend one testing session that is approximately one hour. Baseline Pressure Pain Threshold will be measured followed by random assignment to one of four study arms.

Eligibility criteria: Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Not have had Surgery, injury, or fracture within the past 6 months

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Change from baseline immediately after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT02204189: The Clinical Study of Acute Pancreatitis Treated by TongFuSan
Official title: The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
gastrointestinal dysfunction
TongFuSan
ShenQue acupoint
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

Detailed description: * Patient who is diagnosed with acute pancreatitis(AP) should be included.
* Patients will be divided into two groups as random number table: control group(A) and experimental group(B).
* Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP.
* Same investigator will write the case report form.
* Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day.
* Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests.
* When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of acute pancreatitis，both mild type and severe type

Exclusion Criteria:

* pregnant or suckling
* cancer in late time
* patient near death

Primary outcomes:
measure: the time of first defecation
timeFrame: ten days
Secondary outcomes:
measure: the time of bowel sounds getting back to normal
timeFrame: ten days
Other outcomes:
measure: Hospitalization cost
timeFrame: ten days
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Bin Miao, PHD
role: STUDY_CHAIR
affiliation: Beijing Friendship Hospital
name: Hong Wang, Graduate
role: STUDY_DIRECTOR
affiliation: Beijing Friendship Hospital
name: Shuwen Zhang, bachelor
role: STUDY_DIRECTOR
affiliation: Beijing Friendship Hospital
name: Chao Wang, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Yanli Su, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Shirong Li, graduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Fengwu Li, graduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Dinghua Xu, graduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482789: Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Official title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gestational Diabetes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women (singleton)
* Gestational diabetes not requiring medical therapy
* Between 18 and 50 years of age
* Able to give written informed consent

Exclusion Criteria:

* Women in the first trimester of pregnancy
* Hematocrit less than 30%
* Current or past treatment with any hypoglycemic agent
* Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
* Women with high triglyceride levels, history of gallbladder or pancreatic disease.
* Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of glucose
timeFrame: Baseline and 1 week later
Secondary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of exenatide
timeFrame: 1 week after study enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Maisa Feghali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03285789: Dyslexics' Visual Attention Field
Official title: Evaluation of the Visuo-attention Field of Symbols Versus Objects Visual Search in Dyslexic Subjects. DyslexiaSPOTLIGHT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dyslexia
Keywords: Dyslexia
Visual Fields
visual attention span
visual search
visual attention field
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 1460
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: dyslexia is often considered like a phonological deficit but some researches show that a visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some dyslexics have a reduced V-A field in visual search when the investigator use separable feature (letter-like).

If the investigator demonstrate that, he will show that V-A deficit can be transpose to an ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a consequence of reading problem but a cause of it for some dyslexics.

The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia and make reeducation more specific for the deficit observed.


Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal vision
* diagnosed dyslexics with a recent "alouette" test

Exclusion Criteria:

* other developmental problem (dysphasia, dyspraxia, ADHD)
* strabismus, amblyopia, oculomotor paralysis

Primary outcomes:
measure: Respond time in visual search in different condition of view (full view or reduced view) with separable feature.
timeFrame: Day 0
Secondary outcomes:
measure: respond time in function of the distractors' number
timeFrame: Day 0
measure: visual exploration of the scene
timeFrame: Day 0
measure: visuo-spatial perception
timeFrame: Day 0
measure: visual attention span (VAS)
timeFrame: Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: U1028 INSERM - CNRS UMR 5292 Equipe ImpAct
Study officials:
affiliation: INSERM U1028 - Impact - CRNL
name: Laure PISELLA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586689: Evaluating Alternative Aftercare Models for Ex-offenders
Official title: Evaluating Alternative Aftercare Models for Ex-offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug/Substance Abuse/Addiction
Alcohol Abuse/Addiction
Keywords: Oxford House
recovery
substance abuse
alcohol abuse
addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2012-04-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is examining the relative effects of alternative aftercare models for ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal, randomized field trial that assigns participants to one of three conditions: Oxford House, a professionally-run residential treatment facility, or a control condition that involves usual aftercare chosen by participants (which may include no treatment at all). Oxford Houses are self-run residential recovery homes based on the premise of mutual support. These homes do not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for by the residents. The hypothesis of this study is that Oxford House participants will have as good or better outcomes in terms of substance recovery, recidivism, and health in comparison to the participants who were assigned to the residential treatment facility, and better outcomes in comparison to the control group. In addition, the cost to government/tax payers will be substantially lower given that participants pay their own way.


Eligibility criteria: Inclusion Criteria:

* released from prison/jail in last 24 months
* recovering from alcohol or drug dependence

Exclusion Criteria:

* convicted of violent crime such as murder, aggravated assault
* currently using alcohol or drugs

Primary outcomes:
measure: Relapse/recovery - drug test and self report of alcohol use
timeFrame: last data collection point (wave 5, 2 years after recruitment)
measure: recidivism
timeFrame: last data collection point (wave 5, 2 years after recruitment)
measure: health
timeFrame: last data collection point (wave 5, 2 years after recruitment)
Secondary outcomes:
measure: Drug Taking Confidence Questionnaire (DTCQ)
timeFrame: every 6 months for 2 years
measure: Risk Behavior Survey
timeFrame: every 6 months for 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DePaul University
state: Illinois
Study officials:
affiliation: DePaul University
name: Leonard Jason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jason, L.A., Olson, B.D., Mueller, D.G., Walt, L., & Aase, D.M. (2010). Residential recovery homes/Oxford Houses In B. White & J. Kelly (eds.) Addiction Recovery Management: Theory, Research and Practice. (pp. 143-161). New York: Humana Press.
citation: Jason LA, Ferrari JR. Oxford House Recovery Homes: Characteristics and Effectiveness. Psychol Serv. 2010 May;7(2):92-102. doi: 10.1037/a0017932.