louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02979054: Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2016-12-01
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the performance and safety of T4020 versus saline solution.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with progressive keratoconus
* Patients who signed and dated informed consent

Exclusion Criteria:

* Patient under 18 years
* History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
* Corneal thickness\< 400µm

Primary outcomes:
measure: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
timeFrame: Day 3
measure: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
timeFrame: Day 4
Secondary outcomes:
measure: Corneal Epithelial Defect Size Assessment
timeFrame: Baseline and Day 5
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Varna
country: Bulgaria
facility: Hospital
city: Clermont Ferrand
country: France
facility: CHU
city: Vigo
country: Spain
facility: Hospital
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
Study officials:
References:
Clinical trial NCT02028754: A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Cataract
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of age-related cataract in the study eye
* Scheduled for cataract surgery and lens implant

Exclusion Criteria:

* Diagnosis of ocular surface disease or glaucoma
* Ocular surgery in the past 3 months
* Wearing a corneal contact lens in the study eye

Primary outcomes:
measure: Tear Break-Up Time (TBUT) in the Study Eye
timeFrame: Day 7
measure: Tear Break-Up Time (TBUT) in the Study Eye
timeFrame: Day 30
Secondary outcomes:
measure: Fluorescein Staining Score in the Study Eye
timeFrame: Day 7, Day 30
measure: Lissamine Green Staining Score in the Study Eye
timeFrame: Day 7, Day 30
measure: Results of Schirmer I Test With Anesthetics in the Study Eye
timeFrame: Day 7, Day 30
measure: Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
timeFrame: Day 7, Day 30
measure: Subjective Symptom Total Score in the Study Eye
timeFrame: Day 7, Day 30
Other outcomes:
Locations:
city: Hangzhou
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Yao K, Bao Y, Ye J, Lu Y, Bi H, Tang X, Zhao Y, Zhang J, Yang J. Efficacy of 1% carboxymethylcellulose sodium for treating dry eye after phacoemulsification: results from a multicenter, open-label, randomized, controlled study. BMC Ophthalmol. 2015 Mar 20;15:28. doi: 10.1186/s12886-015-0005-3.
Clinical trial NCT04167254: Sit Down and Play India
Official title: Feasibility of Implementing Sit Down and Play in Routine Visits in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Development, Child
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development.


Eligibility criteria: Inclusion Criteria:

Parents/legal guardians will be eligible if they:

* Are over the age of 18 years
* Have a child between 6 and 10 weeks
* Are presenting to Deshnur and Murgod Primary Health Centers in Karnataka, India for a heatlh visit and
* Self-identify as the "primary caregiver.

Exclusion Criteria:

Parents/legal guardians will be ineligible if they:

* Are less than the age of 18 years
* Have a child who is not between 6 and 10 weeks or
* Have a child who is sick at the time of visit

Primary outcomes:
measure: Parenting Behaviors that Promote Early Childhood developme
timeFrame: 1 month after second immunization visit
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Deshnur
country: India
facility: Deshnur Primary Health Center
state: Karnataka
Study officials:
affiliation: University of Illinois at Chicago
name: Reshma Shah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah R, Herekar V, Metgud D, Kim H, Atkins M, Dhaded S. Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial. Eur J Pediatr. 2022 Jul;181(7):2799-2808. doi: 10.1007/s00431-022-04485-w. Epub 2022 May 5.
Clinical trial NCT01377454: Balance and Mild Traumatic Brain Injury (TBI)
Official title: Wearable Sensor to Detect Postural Instability in People After Mild Traumatic Brain Injury (mTBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Concussion
Traumatic Brain Injury
Keywords: mTBI
concussion
mild Traumatic Brain Injury
balance
sensors
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-06-21
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls or individuals with mild Traumatic Brain Injury (mTBI) or concussion.

Brief summary: The purpose of this pilot project is to determine whether using one inertial sensor on the waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).

Detailed description: The purpose of this pilot project is to gather preliminary data to determine whether using one inertial sensor at the waist during the BESS could provide the examiner with a more immediate, objective, reliable and sensitive way to quantify deficits in postural control in the post-concussive population. The investigators hypothesize that the metrics obtained from the iSWAY will be better able to distinguish mTBI subjects from control subjects than the standard clinical assessment. The specific aims are:

1. To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test.
2. To determine if an instrumented BESS can distinguish mTBI from age-matched control subjects better than the commonly used BESS and to determine the best metrics of sway to separate groups.

Eligibility criteria: Inclusion Criteria:

* Have a mild Traumatic Brain Injury or Concussion
* Between the ages 12-40 years

Exclusion Criteria:

* Out of age range

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
citation: King LA, Horak FB, Mancini M, Pierce D, Priest KC, Chesnutt J, Sullivan P, Chapman JC. Instrumenting the balance error scoring system for use with patients reporting persistent balance problems after mild traumatic brain injury. Arch Phys Med Rehabil. 2014 Feb;95(2):353-9. doi: 10.1016/j.apmr.2013.10.015. Epub 2013 Nov 5.
Clinical trial NCT05776654: Wearable Devices in the Recovery Phase of Acute Exacerbations of COPD (AECOPDs)
Official title: Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease Exacerbation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD currently experiencing an exacerbation.

Brief summary: The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.


Eligibility criteria: Inclusion Criteria:

1. Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
2. Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
3. Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) \< 0.7 (GOLD 1-4)
4. Ability to provide informed consent

Exclusion Criteria:

1. No existing COPD diagnosis
2. History of cardiac arrhythmia
3. Presence of pacemaker/defibrillator
4. Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
5. Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD

Primary outcomes:
measure: Daily symptom score
timeFrame: Daily for 21 days
measure: Daily/nightly respiration
timeFrame: Daily for 21 days
Secondary outcomes:
measure: Daily/nightly heart rate and HR variability
timeFrame: Daily for 21 days
measure: Daily/nightly peripheral body temperature
timeFrame: Daily for 21 days
measure: Activity
timeFrame: Daily for 21 days
measure: Sleep metrics
timeFrame: Daily (nightly) for 21 days.
measure: Autonomic function/Stress
timeFrame: Daily for 21 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre (RI-MUHC)
name: Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365754: Dynamic Stabilization Versus Fusion
Official title: Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degeneration of Lumbar Intervertebral Disc
Keywords: Lumbar degenerative disease
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 440
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 posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

Detailed description: Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
* Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
* Failure of adequate conservative measures for more than 3 months
* Correctly signed informed consent form

Exclusion Criteria:

* Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
* Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
* Previous fusion or stabilization surgery

Primary outcomes:
measure: Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
timeFrame: 2 years after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Prof. Dr. med. Bernhard Meyer
Study officials:
References:
Clinical trial NCT02516254: Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults
Official title: Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin D
fortified bread
efficacy
Vitamin D Deficiency
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.

Detailed description: Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Eligibility criteria: Inclusion Criteria:

* 20 to 50 years
* healthy subjects
* no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion Criteria:

* receiving vitamin D or omega-3 supplement during the study

Primary outcomes:
measure: 25-hydroxyvitamin D (nmol/L)
timeFrame: 8 weeks
Secondary outcomes:
measure: serum glucose (mg/dL)
timeFrame: 8 weeks
measure: serum triglyceride (mg/dL)
timeFrame: 8 weeks
measure: serum total cholesterol (mg/dL)
timeFrame: 8 weeks
measure: serum LDL
timeFrame: 8 weeks
measure: serum HDL (mg/dL)
timeFrame: 8 weeks
measure: serum PTH (pg/mL)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00065754: Brain Imaging and Pain in Irritable Bowel Syndrome
Official title: Brain Imaging and Pain: Analysis of Placebo Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Placebo
Analgesia
Pain
Brain mechanism
Expectation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2003-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This study examines the mechanisms, including brain imaging of placebo analgesia


Eligibility criteria: Inclusion criteria:

* Irritable Bowel Syndrome
* English speaking

Exclusion criteria:

* Chronic pain condition other than Irritable Bowel Syndrome
* Medical condition that would contraindicate use of lidocaine
* Clinical criteria for fibromyalgia
* Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
* Seropositive HIV
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael E Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604654: Effectiveness and Safety of Yiqitongluo Granule for Stroke
Official title: Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Shineway Pharmaceutical Co.,Ltd
First posted: 2015-11-13
Enrollment: 2197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.


Eligibility criteria: Inclusion Criteria:

* mild and moderate ischemic stroke patient with 4-25 NIHSS score
* stable patients within 1 week to 3 months
* sign informed consent before study

Exclusion Criteria:

* CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
* severe disturbance of consciousness
* dysphagia
* TIA
* hemorrhagic diathesis
* patient with malignant tumor whose expected lifetime is less than 3 months
* allergic constitution
* gestation period, lactation period, woman with the possibility or plan of pregnancy
* those who participated in other clinical trials within 3 months or taking part in other clinical trials

Primary outcomes:
measure: Safety of Yiqitongluo for stroke measured by laboratory index
timeFrame: change from baseline laboratory index at 28(±7) days
Secondary outcomes:
measure: Effect of Yiqitongluo for stroke with mRS
timeFrame: 90(±7) days
measure: Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
timeFrame: 28(±7) days
measure: Effect of Yiqitongluo for stroke with NIHSS
timeFrame: 28(±7) days
measure: Effect of Yiqitongluo for stroke with BI
timeFrame: 28(±7) days
measure: Effect of Yiqitongluo for stroke with EQ-5D
timeFrame: 28(±7) days
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Yi Yang
role: STUDY_CHAIR
affiliation: The First Hospital of Jilin University
name: Zhenni Guo
role: STUDY_DIRECTOR
References:
Clinical trial NCT02069054: Airway Inflammation and Remodeling in Asthma and COPD.
Official title: Relationship Between Airway Inflammation and Remodeling in Asthma and COPD Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Keywords: asthma
COPD
airway inflammation
remodeling
cytokines
airway wall thickness
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with stable asthma and COPD invited to Clinical Hospital in Warsaw

Brief summary: Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.

The aim of this study is:

* to evaluate airway inflammation in asthma and COPD,
* to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
* to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.

Material and methods:

* mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
* mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
* healthy subjects as controls.

Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.

We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.


Eligibility criteria: Inclusion Criteria:

* a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
* control group - healthy volunteers without any history of lung disease

Exclusion Criteria:

* age below 18 years
* exacerbation in the past 6 weeks
* inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
* significant co-morbidities

Primary outcomes:
measure: Inflammatory markers
timeFrame: Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)
measure: Airway wall thickness
timeFrame: Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097
Study officials:
References: