louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02942940: Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients
Official title: Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament (ACL) Tear
Lead sponsor: University of Toronto Orthopaedic Sports Medicine
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Telemedicine is increasingly used to overcome distance between patients and physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction patients is feasible, can avert in-person follow-up care, and is cost-effective.

Objective: To avert in-person follow-up through the use of a mobile app in the first six weeks after surgery.

Methods: This will be a single-center, prospective randomized controlled trial

Results: Data to be analyzed from 72 patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing ACL reconstruction at Women's College Hospital (WCH), between the ages of 18-70.
* Patients must be able to use a mobile device and communicate in English.

Exclusion Criteria:

* Patients who are smokers, as they carry increased rates of complications.
* Patients must not:

  * Suffer from chronic pain
  * Be taking narcotic (morphine-like) medication for pain on a regular basis, and
  * Have an allergy to local anesthetics or morphine-like medications

    * Pain scores captured in the VAS and QoR-9 are important for judging post-operative recovery. Pre-existing pain or inability to take narcotics post-operatively would compromise the reliability of these measures.

Primary outcomes:
measure: Required physician visits
timeFrame: 6 weeks post surgery
Secondary outcomes:
measure: Health care phone calls
timeFrame: 6 weeks post surgery
Other outcomes:
measure: Cost of treatment
timeFrame: through study completion (approximately one year)
measure: Patient satisfaction with post-operative care
timeFrame: 6 weeks post surgery
measure: Patient satisfaction with post-operative care
timeFrame: 6 weeks post surgery
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00365040: Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
Official title: Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: myopia
excimer laser
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik


Eligibility criteria: Inclusion Criteria:

* Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease

Exclusion Criteria:

* Diabetes, autoimmune diseases, topographic abnormalities

Primary outcomes:
measure: visual acuity
measure: refractive errors
measure: topography patterns
measure: aberrometry data
Secondary outcomes:
measure: subjective evaluation
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Mauro Campos, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05139940: Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia
Official title: Validation of Artificial Intelligence Enabled TB Screening and Diagnosis in Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Screening
Diagnosis
Artificial Intelligence
Chest X-ray
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 2432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted from Chainda South Clinic, Chawama and Kanyama General Hospitals. These facilities are selected based on existing access to digital radiography. Participants will be drawn from patients attending these health facilities for:

* Health services
* TB households of those who are close contacts of TB households within the catchment area of these facilities

Brief summary: Tuberculosis (TB) is a global epidemic and for many years has remained a major cause of death throughout the developing world. Zambia is among the top 30 TB/HIV high burden countries. Chest X-ray (CXR) is recommended as a triaging test for TB, and a diagnostic aid when available. However, many high-burden settings lack access to experienced radiologists capable of interpreting these images, resulting in mixed sensitivity, poor specificity, and large inter-observer variation. In recognition of this challenge, the World Health Organization has recommended the use of automated systems that utilize artificial intelligence (AI) to read CXRs for screening and triaging for TB. In this study, we primarily evaluate the performance of our AI algorithm for TB, and secondarily for Abnormal/Normal.


Eligibility criteria: Inclusion Criteria:

* Participants who are 18 years and older with a known HIV status or are willing to undergo HIV testing if unknown HIV status and meet the following criteria will be included in the study:

  * Presumptive TB patients defined as having any of the following:

    ○ Cough, Weight loss, Night sweats, Fever
  * Household /close TB contacts regardless of symptoms
  * Newly diagnosed HIV regardless of symptoms.

Exclusion Criteria:

* Individuals who do meet the above inclusion criteria will be excluded. In addition, individuals with history of TB treatment within 365 days prior to enrolment will be excluded.

Primary outcomes:
measure: Pilot Group to calibrate the operating points for AI algorithms
timeFrame: 2 months
measure: Main Cross Sectional Group
timeFrame: 7 months
Secondary outcomes:
measure: Main Cross Sectional Group:
timeFrame: 7 months
measure: Main Cross Sectional Group
timeFrame: 7 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chainda South Health Facility
city: Lusaka
country: Zambia
facility: Chawama first level hospital
city: Lusaka
country: Zambia
facility: Kanyama level 1
Study officials:
References:
Clinical trial NCT01588340: MRI Hydronephrosis Study
Official title: Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hydronephrosis
Kidney Swelling
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 0
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.

Detailed description: Ultrasound is the most commonly performed imaging modality used to assess hydronephrosis. The average renal ultrasound exam takes about 15-25 minutes to complete, however, it does have several disadvantages, including substantial operator dependence, having to rely on an adequate "sonographic window" to see the structures of interest and difficulty in visualization of portions of the kidney and urinary tracts.

Recent MRI advances have made rapid imaging possible. Such imaging has minimized motion related artifacts and need for sedation.

This study is to compare traditional ultrasound imaging to a raid noncontrast protocol MRI examination of the kidneys and urinary tract that would require no sedation and less than 15 minutes to perform.

Eligibility criteria: Inclusion Criteria:

* Children 2 years of age and younger
* Diagnosed with hydronephrosis and scheduled for an ultrasound scan

Exclusion Criteria:

* Healthy subjects

Primary outcomes:
measure: To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient.
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04106440: Pilot Study of Connected Diabetes Technology
Official title: Pilot Study of Connected Diabetes Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 41
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Use of applications to share data
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To test the hypothesis that remote sharing of health data - including measured blood glucose values as well as patient-reported carbohydrate counts and insulin doses - with the UC Davis Pediatric Diabetes team via connected health applications is feasible for pediatric patients with newly diagnosed type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with T1D in the past 6 weeks
* Daily access to the internet via a wireless connection

Exclusion Criteria:

* Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
* Primary caregiver does not speak English

Primary outcomes:
measure: Connected Health Survey
timeFrame: 1 month after diabetes diagnosis
measure: Connected Health Survey
timeFrame: 6 months after diabetes diagnosis
Secondary outcomes:
measure: Frequency of blood glucose monitoring
timeFrame: At each clinic visit until 6 months since diagnosis
measure: Hemoglobin A1c values
timeFrame: At each clinic visit until 6 months since diagnosis
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
References:
citation: Crossen S, Romero C, Reggiardo A, Michel J, Glaser N. Feasibility and Impact of Remote Glucose Monitoring Among Patients With Newly Diagnosed Type 1 Diabetes: Single-Center Pilot Study. JMIR Diabetes. 2022 Jan 17;7(1):e33639. doi: 10.2196/33639.
Clinical trial NCT00781040: Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
Official title: Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Severe sepsis in neutropenic haematological patients
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis

Brief summary: The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.

Detailed description: Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).

Eligibility criteria: Inclusion Criteria:

* diagnosis: acute myeloid leukaemia
* age under 70 years
* neutropenic fever

Exclusion Criteria:

* age above 70 years
* no neutropenic fever

Primary outcomes:
measure: This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers.
timeFrame: Within neutropenic period after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Esa Jantunen, M.D, PhD
role: STUDY_DIRECTOR
References:
citation: Vanska M, Koivula I, Hamalainen S, Pulkki K, Nousiainen T, Jantunen E, Juutilainen A. High pentraxin 3 level predicts septic shock and bacteremia at the onset of febrile neutropenia after intensive chemotherapy of hematologic patients. Haematologica. 2011 Sep;96(9):1385-9. doi: 10.3324/haematol.2011.044925.
Clinical trial NCT06607640: Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool Children
Official title: Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Axial Length
Myopia
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 210
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.

Detailed description: Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.

Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.

Eligibility criteria: Inclusion Criteria:

* Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
* Able to cooperate with eye examinations and questionnaires.

Exclusion Criteria:

* Communication barriers, unable to cooperate.
* Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
* Children currently using orthokeratology lenses or rigid contact lenses.
* Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.

Primary outcomes:
measure: The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
timeFrame: at baseline, at the 6th month of the intervention, and at the 12th month.
Secondary outcomes:
measure: The incidence of myopia.
timeFrame: at baseline, at the 6th month of the intervention, and at the 12th month.
Other outcomes:
Locations:
Study officials:
affiliation: Anhui Medical University
name: Yang Feng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136240: Automated Telephone System to Improve Treatment Adherence in People With Depression
Official title: Telecom System to Improve Adherence to Antidepressants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-08-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

Detailed description: The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.

Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
* Prescribed at least one antidepressant medication
* Access to a telephone with touch-tone service
* Speak and understand conversational English

Exclusion Criteria:

* Current significant alcohol or drug abuse
* Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
* Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
* Alzheimer's disease and other dementia
* Cancer, undergoing radiation therapy or chemotherapy
* Suffering from Renal disease or on dialysis
* Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus \[SLE\], etc.)
* HIV
* Terminal illness
* Homeless
* Legally blind
* Planning to leave the geographic area during the study period

Primary outcomes:
measure: Antidepressant medication adherence
timeFrame: Measured monthly for 4 months
measure: Adherence to scheduled psychiatry clinic visits
timeFrame: Measured monthly for 4 months
Secondary outcomes:
measure: Depression status, measured by self-administered depression inventory scale
timeFrame: Measured at baseline and at 4 month follow-up
measure: General health status, measured by self-rating health survey
timeFrame: Measured at baseline and at 4 month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Ramesh Farzanfar
role: STUDY_DIRECTOR
References:
Clinical trial NCT00023140: Collaborative Study of 1,3 Butadiene Biomarkers
Official title: Collaborative Study of 1,3 Butadiene Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: biomarkers
exposure
adducts
metabolites
butadiene
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are difficult to measure by air sampling. This study examines the relationship between air levels and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or waste products. Adducts are materials formed when a chemical reacts with a biological material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA adducts, and urinary metabolites. If a strong relationship is found then the amounts of biomarkers in a person's blood or urine can tell us how much they have been exposed. The tests are being conducted on petrochemical workers who have a wide range of exposures to butadiene. An international group of investigators is conducting the study.


Eligibility criteria: Healthy adults without metabolic disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
city: Tainan
country: Taiwan
facility: National Chung Kung University
Study officials:
References:
Clinical trial NCT02855801: Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy
Official title: Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthritis, Rheumatoid
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.


Eligibility criteria: Inclusion Criteria:

* Men and women \>18 years old, \< 80 years old
* Signature of informed consent for participation
* Affiliation to a social security scheme or French beneficiary of such a regime.
* confirmed rheumatoid arthritis and monitoring by the rheumatology department of the University Hospital of Besancon.
* If there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day
* Clinical and biological activity will be moderate (ie not in remission and not severe based on Disease Activity Score 28 joints - DAS 28 - to be between 2 and 6
* Patients could be treated with DMARDs (Disease-Modifying Drugs).

Exclusion Criteria:

* Patient under guardianship, curatorship, under judicial protection, major incapable
* Patients whose body mass index (BMI) greater than 30,
* Pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...)
* Change in DAS28 greater than 1.2 in the previous 3 months Inclusion
* A patient with a DAS28 \> 6
* about the cold: Raynaud's syndrome, cold known allergy, sickle cell anemia, cryoglobulinemia, uncontrolled hypertension
* Patient unable to follow protocol because of cognitive, psychiatric or language difficulties.
* Inability to follow protocol for causes related to health problems (unrelated Rheumatoid Arthritis) or socio-professional.

Primary outcomes:
measure: plasma concentration of C-reactive protein
timeFrame: 48 hours after the end of the exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Régional Universitaire
state: Franche-Comté
Study officials:
affiliation: CHRU Besancon
name: Clement Pati, MD
role: PRINCIPAL_INVESTIGATOR
References: