louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05158049: Longitudinal Study of a Bionic Eye
Official title: Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Retinitis Pigmentosa
Choroideremia
Lead sponsor: Center for Eye Research Australia
Sponsor class: OTHER
Collaborators: name: The Bionics Institute of Australia
name: Australian National University
name: Commonwealth Scientific and Industrial Research Organisation, Australia
name: Bionic Vision Technologies
First posted: 2021-12-15
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who were implanted with a suprachoroidal retinal prosthesis.

Brief summary: This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.

Detailed description: To observe and assess visual, orientation and mobility behavior with primary and adjunct vision processing (AVP) methods that may enhance the performance with the suprachoroidal retinal prosthesis (ScRP). To investigate the effectiveness of primary and AVP methods in the laboratory and real-world environments with the ScRP. Assess structural and functional ScRP stability with objective and subjective assessments. Record participant experiences and feedback with the ScRP.

Eligibility criteria: Inclusion Criteria:

* Willing to provide signed informed consent;
* Implanted with a suprachoroidal retinal prosthesis;
* Be available for the study visits;
* Willing to comply with study assessments;
* In good general health and mobile.

Exclusion Criteria:

* Medical condition that prohibits mobility;
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Primary outcomes:
measure: Effectiveness of vision processing method in the laboratory.
timeFrame: 5 years.
measure: Effectiveness of vision processing method in the 'real world' featured environment.
timeFrame: 5 years.
Secondary outcomes:
measure: Device stability and functionality.
timeFrame: 5 years.
measure: Participant experience.
timeFrame: 5 years
measure: Participant interview.
timeFrame: 5 years
Other outcomes:
Locations:
city: Melbourne E.
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
Study officials:
affiliation: Center for Eye Research Australia
name: Penelope J Allen, FRACO, FRACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06898749: Impact of Canine Mediation Practice in Psychomotor Therapy on Improving the Quality of Life in Adult Epileptic Patients.
Official title: Impact of Canine Mediation Practice in Psychomotor Therapy on Improving the Quality of Life in Adult Epileptic Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Institut La Teppe
First posted: 2025-03-27
Enrollment: 76
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: In addition to the search for new pharmaceutical or surgical solutions that could improve the therapeutic management of epileptic individuals, it is interesting to ask whether other complementary approaches, such as canine mediation in psychomotor therapy, could enhance the quality of life in this population.

However, there is currently no evidence indicating that exposure to animals through mediation sessions would be beneficial for epileptic individuals, particularly regarding their quality of life, anxiety, emotional management, or cognition (such as social cognition). In the absence of current data in this population, it seems pertinent to study the impact of this practice on people with epilepsy. Furthermore, beyond quality of life, it would be valuable to examine whether it also influences anxiety or the frequency of seizures in individuals with epilepsy (a phenomenon reported for epileptic individuals living with a pet dog or a service dog). Canine mediation could help better manage and regulate the emotions of epileptic individuals, as well as improve their self-esteem.


Eligibility criteria: Inclusion Criteria:

* Person aged ≥ 18 years
* Presenting pharmacoresistant epilepsy according to the criteria of the International League Against Epilepsy
* Requiring psychomotor therapy sessions for one of the following indications:

Difficult emotional and relational management And/or global motor difficulties And/or body schema organization disorder And/or temporo-spatial disorder

* Explicit consent or no opposition to participation in the study by the patient and/or their legal representative or guardian
* Image rights consented by the patient and their legal representative or guardian, if applicable
* Hospitalization or residence at the Teppe Institute or at the FAM (Foyer d'Accueil Médicalisé) des 4 Jardins planned for at least 3 months
* Affiliated with or a beneficiary of a social security scheme

Exclusion Criteria:

* Fear or phobia of dogs
* Epileptic person benefiting from a legal protection measure other than guardianship or curatorship
* Person with insufficient cognitive abilities to respond to the questionnaires
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Improvement of quality of life
timeFrame: Day 0 and Day 7 after the end of the 10 sessions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05618249: Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age
Official title: Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age When Taking Over a Patient Base in the SOULTZ Haut-Rhin Sector
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Disease
Keywords: Peptic Ulcer Disease
Proton pump inhibitors
PPI
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient, over 75 years of age, with a PPI in the initial prescription

Brief summary: This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018.

It aims to highlight and quantify a possible inappropriate use of PPIs in private practice.


Eligibility criteria: Inclusion criteria:

* Patient over 75 years of age
* Patient with a PPI in the initial prescription
* Patient seen at least once between 01/01/2018 and 31/11/2019 in the general practice
* Patient who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research.

Exclusion criteria:

* Patient having expressed his opposition to participate in the study
* Impossibility to give the patient informed information (difficulties in understanding the subject, ...)
* Patient under legal protection
* Patient under guardianship or curatorship
* Patient who is no longer followed up in the office following an entry into an institution (EHPAD)

Primary outcomes:
measure: Retrospective systematic analysis of patient prescriptions to identify possible inappropriate use of PPIs in private practice
timeFrame: Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gériatrie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03871049: Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries
Official title: Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: effect of intrathecal dexamethasone on blood sugar of dietetic patients


Eligibility criteria: Inclusion Criteria:

* control diabetic patients will undergo foot surgeries.

Exclusion Criteria:

* The exclusion criteria included patient refusal, patients with major cardiac, respiratory, renal, hepatic disorders or uncontrolled diabetes mellitus, history of chronic use of analgesic medication or hypersensitivity to drugs under investigation, any contraindication to regional anesthesia, namely; patients with coagulopathy infection at puncture site, backache, spine deformity or prior surgery, neuromuscular disorders or psychic disturbances

Primary outcomes:
measure: blood sugar
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT00162149: ATV/Ritonavir Nevirapine Interaction (USPAC)
Official title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.


Eligibility criteria: Inclusion Criteria:

* signed informed consent form
* For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks
* For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 weeks
* Have had 2 measurements of plasma HIV RNA of \<400 copies/mL. The first test being 6 to 16 weeks prior and the second being within 3 weeks prior to Day 1
* Have CD4 cell count \>=200 cells/mm3
* Body Mass Index of 18 to 35 kg/m2.
* Men and women, ages 18 to 55.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Presence of a newly diagnosed HIV-related opportunistic infection or CD4 cell count \<200 cell/mm3 within the previous 6 months.
* Any significant acute or chronic medical illness, unless stable or controlled by a non-prohibited medication.
* History of virologic failure on an antiretroviral regimen.

Primary outcomes:
measure: Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.
Secondary outcomes:
measure: Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Local Institution
state: California
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05471349: Message Testing in Older Adult Smokers
Official title: Message Testing in Older Adult Smokers (MCAS-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Centiment LLC
First posted: 2022-07-22
Enrollment: 820
Sex: ALL
Minimum age (years): 50
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 is examining different messages to motivate older smokers to quit smoking. Participants will be current smokers, between the ages of 50-80 years old, who do not have a history of cognitive impairment or dementia. Participants can expect to take part in a one-time 30 minute online survey.


Eligibility criteria: Inclusion Criteria:

* Current smoker (smoking at least some days per week)
* Ability to read and write English
* Between the ages of 50 and 80 years old

Exclusion Criteria:

* History of Mild Cognitive Impairment or dementia

Primary outcomes:
measure: Emotional Response
timeFrame: Through study completion, approximately 30 minutes
measure: Motivation to Quit
timeFrame: Through study completion, approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Adrienne Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174249: Exposure Therapy Combined With Cortical Interventions for CRPS-II
Official title: Leaving the Wheelchair Behind - Treating CRPS-II With Exposure Therapy Combined With Cortical Interventions: a Series of Case Reports
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: Behavioural therapy
Exposure in vivo
Cortical reorganisation
Mirror therapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Folksam
First posted: 2017-06-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A series of case-studies
Primary purpose: TREATMENT

Brief summary: Consecutive patients with long-standing complex regional pain syndrome II in a lower limb are treated with graded exposure therapy in vivo in combination with methods targeting cortical reorganisation.

Detailed description: Complex regional pain syndrome, CRPS, is an uncommon but often very handicapping chronic pain syndrome. Most often, a single extremity is affected. The diagnosis is subdivided in CRPS type I where no nerve injury has been identified, and CRPS type II when a major nerve injury has been verified. With the exception of spontaneous pain, several of the symptoms related to CRPS may be connected to the inactivity and immobilization often seen in the history of CRPS patients.

Exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with the avoided movements and activities, has been shown safe and effective for patients with CRPS type I. The present study uses a combination of exposure in vivo and interventions targeting a supposed cortical reorganisation with the hypothesis that the functional impairments would decrease, independent of possible changes in pain levels.

Consecutive patients with long-standing CRPS-II, diagnosed according to the Budapest criteria, in a lower limb are included. Treatment comprises daily graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation: mirror therapy, desensibilisation training, and sensory re-education. The treatment is implemented at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.

Eligibility criteria: Inclusion Criteria:

* Complex regional pain syndrome II

Exclusion Criteria:

* Severe psychiatric disorder drug abuse

Primary outcomes:
measure: Photograph series of daily activities, PHODA
timeFrame: 12 weeks
Secondary outcomes:
measure: The Tampa Scale of Kinesiophobia - Short Form, TSK-SF
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university hospital
Study officials:
affiliation: Uppsala University
name: Torsten Gordh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03949049: Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
Official title: Efficacy of Citicoline as Neuroprotector in Neonates Exposed to Hypoxia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neonatal Hypoxia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Detailed description: Efficacy of Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Eligibility criteria: Inclusion Criteria:

* neonates with hypoxia.

Exclusion Criteria:

* hypoxic ischemic encephalopathy

Primary outcomes:
measure: number of seizures
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Pediatrics department - Kafr-Elsheikh university
name: Abeer Salamah, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrics department - Tanta university
name: May R Elsheikh, Lecturer
role: STUDY_CHAIR
References:
Clinical trial NCT06966349: Quantifying Ocular Surface Aberrations After Tear Film Interventions
Official title: Quantifying Ocular Surface Aberrations After Tear Film Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Tear Film Characteristics
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.


Eligibility criteria: Inclusion Criteria:

1. Are at least 17 years of age and have full legal capacity to volunteer.
2. Have signed the information consent letter.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
5. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
6. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
7. Agree to wear the study contact lenses for at least 6 hours.
8. Have clear corneas (e.g. no central scars).
9. Have no active ocular disease or inflammation.

Exclusion Criteria:

1. Are participating in another concurrent clinical research study.
2. Have worn any rigid contact lenses in the past 30 days.
3. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
4. Have any known active ocular condition, disease, and/or infection.\*
5. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
6. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
7. Have undergone refractive error surgery.
8. Are a member of the study team for this study, i.e. are listed on the delegation log for this study.

Primary outcomes:
measure: Change in higher order aberrations with an eye drop
timeFrame: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop
measure: Change in higher order aberrations with senofilcon A
timeFrame: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
measure: Change in higher order aberrations with somofilcon A
timeFrame: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Ocular Research & Education
name: Lyndon Jones, PhD, DSc, FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00280449: Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
Official title: Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS (PHAs): The Comparative Impact on Quality of Life, Access to and Expenditures for All Health and Social Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infection
Keywords: people living with HIV
quality of life
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2006-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of having a case manager help PHAs access and use health, social services and practical resources that are helpful to their needs as compared to the usual more PHA self-managed approach of deciding and using services as they see necessary. New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce Regions who consent to this study will be randomized to receive their usual self-directed supportive, educational, medical and medical care services when they seek assistance according to their needs or these usual services augmented by case management services. They will be measured before randomization and at 3, 6 and 12 months following service use for their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement in quality of life, psychological distress, risk behaviours and expenditures for the use of a range of publicly funded services.


Eligibility criteria: Inclusion Criteria:

* HIV-positive individuals
* living in the community setting

Exclusion Criteria:

* cognitive impairment

Primary outcomes:
measure: risk behavior, quality of life, health and social service utilization
Secondary outcomes:
measure: depression, satisfaction
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Adriana Carvalhal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: