louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831802: Embrace and Quality of Life
Official title: Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy, Tonic-Clonic
Keywords: epilepsy
mhealth
quality of life
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 26
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: A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. These measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.


Eligibility criteria: Inclusion Criteria:

* male or female aged \>18 years old
* clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure
* primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion
* seizure frequency \> 1 seizure/month during the last three months
* signed the informed consent form
* own a mobile phone device compatible with the embrace apps
* able to use the device without help from caregivers

Exclusion Criteria:

* patients aged less than 18 years old
* epilepsy diagnosis remains uncertain
* evidence of psychogenic non epileptic seizures
* seizure frequency below 1/month during any of the three previous months
* past-history of nickel allergy and contact dermatitis
* did not sign the informed consent form
* does not own mobile phone device compatible with the embrace apps
* cognitive or behavioral impairment preventing compliance or correct use of the device and app.

Primary outcomes:
measure: The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
timeFrame: 3 month
Secondary outcomes:
measure: The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains:
timeFrame: 3 month
measure: Total number of true and false positives seizure detection
timeFrame: 3 month
measure: The usability total score of Embrace and Mate apps
timeFrame: 3 month
measure: The utility total score of the system in general
timeFrame: 3 month
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Neurotech
Study officials:
References:
Clinical trial NCT04169802: Study Evaluating Retinal Health Monitoring System Visual Acuity Module.
Official title: An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: Age-Related Macular Degeneration
visual acuity
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD

Brief summary: Assess the performance and usability of the RHMS Visual Acuity Module.

Detailed description: This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.

Eligibility criteria: Inclusion Criteria:

Cohort 1 - Normal subjects

1. Age ≥ 50 years
2. Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
3. Able to perform self-testing with the Visual Acuity Module of the RHMS after training
4. Able and willing to give informed consent

Cohort 2 - Subjects with neovascular AMD

1. Age ≥ 50 years
2. History of neovascular age-related macular degeneration, in the study eye
3. Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye

Exclusion Criteria:

Cohort 1 - Normal subjects

1. History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
2. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Cohort 2 - Subjects with neovascular AMD

1. History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
2. History of macular hole in the study eye
3. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days

Primary outcomes:
measure: Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
timeFrame: 1 day
measure: Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
timeFrame: 1 day
measure: Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retina Consultants of Arizona
state: Arizona
Study officials:
affiliation: Kubota Vision Inc.
name: Jeff Gregory, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01253902: Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 164
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: This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
* Best corrected visual acuity score of 20/100 or better in both eyes
* Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

* Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
* History of or active ocular infection/inflammation (eg, uveitis)
* Punctal plug use
* Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
* Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
* History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
* Planned contact lens wear during study

Primary outcomes:
measure: Mean Conjunctival Hyperemia at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Mean Corneal Staining With Fluorescein at Week 12
timeFrame: Week 12
measure: Mean Tear Break Up Time (TBUT) at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Rogers
country: United States
state: Arkansas
city: Calgary
country: Canada
state: Alberta
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Schwartz GF, Hollander DA, Williams JM. Evaluation of eye drop administration technique in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2013 Nov;29(11):1515-22. doi: 10.1185/03007995.2013.833898. Epub 2013 Sep 5.
citation: Crichton AC, Vold S, Williams JM, Hollander DA. Ocular surface tolerability of prostaglandin analogs and prostamides in patients with glaucoma or ocular hypertension. Adv Ther. 2013 Mar;30(3):260-70. doi: 10.1007/s12325-013-0014-7. Epub 2013 Mar 7.
Clinical trial NCT05796102: PET-MRI Esophagus Feasibility Study
Official title: Feasibility Study of PET-MRI as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Esophagogastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophagogastric Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single arm, single centre, investigator initiated study to investigate the feasibility of using PET-MRI imaging in radiation treatment workflow in up to 15 patients with esophagogastric cancer. PET-MRI imaging will be completed before the start of radiation treatment. MRI imaging will be completed during radiation treatment and after radiation treatment. These images will not be used to plan the radiation treatment and routine clinical care will be provided.

The goal of this study is to gather information that will allow the radiation team to include MRI and PET imaging into the radiation treatment workflow for patients with esophageal cancer receiving radiation therapy in the future.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Diagnosed with locally advanced esophageal cancer being considered for conventional RT \>4 weeks
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Contraindication for MRI
* Contraindication for Gadolinium (i.e. inability to lie supine for at least 60 minutes)
* Any patient who is pregnant or breastfeeding
* Pacemaker or implanted defibrillator
* Claustrophobia

Primary outcomes:
measure: Feasibility of PET-MRI to visualize and assess impact of RT treatments on esophagogastric tumors
timeFrame: 2 years
Secondary outcomes:
measure: Difference in manual GTV segmentation using PET-MRI
timeFrame: 2 years
measure: Quantification of dosimetric advantages of PET-MRI treatment plan
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT05792202: Combined Microfracture Procedure Promotes Tendon Healing
Official title: Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Full Rotator Cuff Tear
Microfracture Procedure
Double Raw Repair
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized controlled study of Combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and 6 weeks, 3 months, 6 months, 12 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of Crimson duvet procedure with Greenhouse procedure on the treatment of rotator cuff.


Eligibility criteria: Inclusion Criteria:

* Arthroscopy confirmed small to medium full rotator cuff tear
* Unilateral rotator cuff injury
* Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
* Young and middle-aged patients aged 20 to 60

Exclusion Criteria:

* Previous shoulder surgery (incision or arthroscopy)
* Combined with diseases of other parts of the same limb
* Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
* Bilateral onset
* Unable or unwilling to receive clinical follow-up

Primary outcomes:
measure: rotator cuff re-tear rate
timeFrame: 2 year postoperatively
Secondary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.
measure: ASES（American Shoulder and Elbow Surgeons'Form）
timeFrame: 3,6,12,24 months postoperatively
measure: Constant score
timeFrame: 3,6,12,24 months postoperatively
measure: UCLA (University LosAngeles scoring system)
timeFrame: 3,6,12,24 months postoperatively
measure: SST (simple shoulder test)
timeFrame: 3,6,12,24 months postoperatively
measure: front extension, external rotation and internal rotation strength of shoulder
timeFrame: 6,12,24 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03879902: The Characteristics of Falls and Its Potential Predictors
Official title: The Characteristics of Falls in Community-dwelling Older Adults in Hong Kong and Its Potential Predictors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall Patients
Keywords: fall
elderly
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 2101
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older adults with fall history

Brief summary: A prospective study to examine the fall characteristics among elderly faller in Hong Kong and the potential predictors of falls incidence.

Detailed description: This will be a prospective study. One thousand and five hundred older fallers would be recruited. Baseline assessments would be conducted to examine potential fall risk factors and the fall history. The subjects would be followed up for 1 year for fall incidence. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* aged 60 or older
* able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
* able to walk for ≥ 10 meters
* history of falls in the past 12 months
* living in the community
* able to understand Chinese

Exclusion Criteria:

* blindness

Primary outcomes:
measure: Number of falls
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control
Study officials:
affiliation: Chinese University of Hong Kong
name: Timothy Kwok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04272502: Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-02-17
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who cannot participate in a clinical trial based on the PI's judgment

Primary outcomes:
measure: Cmax
timeFrame: 0 hour ~ 144 hour
measure: AUCt
timeFrame: 0 hour ~ 144 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT00138502: Funguria in Hospitalized Patients
Official title: The Significance of Funguria In Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis
Keywords: Candidiasis, Funguria
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-08-30
Enrollment: 926
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy.

Detailed description: This protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. In addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. Finally, it will attempt to determine if funguria independently predicts fungemia or death. Data will be complemented by surveillance of a comparable population without funguria.

Eligibility criteria: Inclusion Criteria:

1. Subjects with fungi isolated from the urine of any colony count.
2. Patients seen at either Harbor-UCLA Medical Center or Cedars Sinai Medical Center.

Exclusion Criteria:

1. Persons with a previously positive urine fungal culture during the current hospital admission.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Torrance
country: United States
facility: UCLA Center For Vaccine Research
state: California
Study officials:
References:
Clinical trial NCT01660802: Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.


Eligibility criteria: Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

* History of glaucoma, ocular hypertension or optic nerve head change
* Any active bacterial, viral, parasitic, or fungal infections in either eye
* Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
* History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
* Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
* Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
* Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Primary outcomes:
measure: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Average Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, 6 Months
measure: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.
Clinical trial NCT03794102: Water Versus Saline as Irrigation Fluid for Ureteroscopy
Official title: The Effects of Water Versus Saline on Absorption Rates and Visualization During Ureteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Stricture
Hydronephrosis
Urothelial Carcinoma
Urolithiasis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 150
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 determine the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. The investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used.

Detailed description: The use of fluid irrigation is important during urologic procedures. There is little research done on the use of water versus saline for irrigation during ureteroscopy.

This study will evaluate whether the use of water or saline during ureteroscopy has any clinical implications. The investigators will compare the amount of fluid absorbed and differences in electrolytes between the two participant groups.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Participants meeting medical requirements to undergo ureteroscopy

Exclusion Criteria:

* None

Primary outcomes:
measure: Amount of irrigation fluid used during ureteroscopy
timeFrame: Measurement will be performed day of ureteroscopy
measure: Change in serum sodium levels
timeFrame: Measurement will be performed day of ureteroscopy
measure: Surgeon's rating of ureteroscopic visualization
timeFrame: Measurement will be performed day of ureteroscopy
measure: Measurement of fluid clarity
timeFrame: Measurement will be performed day of ureteroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References: