louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01942057: Myopia Prevalence in Canadian School Children - a Pilot Study
Official title: Myopia Prevalence in Canadian School Children - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 173
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School children in Waterloo Region

Brief summary: The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.


Eligibility criteria: Inclusion Criteria:

* Has had a parent/legal guardian read the study consent form and who agrees to allow them to participate in the study by signing the consent form
* Has had the "letter of assent for children" explained to them, the child has agreed to participate and the letter has been signed by the study investigator and the child
* Has provided the completed Questionnaire (Appendix 4A for parents to complete on behalf of their children in school grades 1 and 2, 6 and 7; Appendix 4B for children to complete that are in school grades 11 and 12)
* Is currently in school grades 1 and 2, 6 and 7 or 11 and 12
* Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria:

* Has not given verbal assent to participate
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Has undergone refractive error surgery or orthokeratology
* Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests

Primary outcomes:
measure: Number of children with spherical equivalent refraction of at least -0.50D in at least one eye
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: Center for Contact Lens Research
name: Lyndon Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03565757: Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer
Official title: Feasibility and Acceptability of a Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer Undergoing Outpatient Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Advanced Cancer
Keywords: Stress Management
Resilience
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines Stress Management and Resilience Training (SMART) for family caregivers (FCG) of patients receiving chemotherapy for advanced cancer to potentially help with the stressful aspects of providing care. All participants will receive the SMART intervention.

Detailed description: FCGs experience stress and extensive demands in providing care for those with head and neck cancer. Teaching the principles of mindfulness and compassion to FCGs has the potential to protect their psychological health and well-being. This may allow them to provide effective, compassionate care to patients, which ultimately puts the needs of the patient first.

Mindfulness interventions have demonstrated decreased stress and anxiety, and improved self-compassion for individuals, but entail numerous sessions over several weeks, a barrier for caregivers. The SMART program, a brief mindfulness program, has demonstrated improvements in resilience, anxiety, perceived stress, and mindfulness for healthcare providers and patients.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver of patient with advanced head and neck cancer receiving chemotherapy, living with the patient at least 50% of the time during treatment, able to read and speak English, cognitively intact, able to take SMART class within 2 weeks of enrollment

Exclusion Criteria:

* Self-identified mental health diagnoses, less than 18 years of age, not living with patient at least 50% of the time, unable to read and speak English

Primary outcomes:
measure: Mean Satisfaction score at 8 weeks
timeFrame: Week 8
measure: Change in Mean Self Compassion Scale-Short Form Score at 8 weeks
timeFrame: Baseline and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sherry Chesak, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05814757: OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Official title: A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Eye Diseases
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED

Detailed description: Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.

Eligibility criteria: Inclusion Criteria:

* VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
* Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
* Unanesthetized Schirmer of \> 0 and ≤ 10 mm.
* Must not have used Artificial Tears during the Screening period.
* IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.

Exclusion Criteria:

* Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
* Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) \< 5 mmHg or \> 24 mmHg.

Primary outcomes:
measure: Severity of Eye Dryness Score (visual analogue scale (VAS))
timeFrame: Change from baseline (CFB) at Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Ocular Therapeutix
state: Tennessee
Study officials:
References:
Clinical trial NCT05008757: Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II
Official title: Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Indirect Calorimetry
Keywords: indirect calorimetry
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers who practice more than 1 hour per day at moderate intensity

Brief summary: Comparison of indirect calorimetry by Q-NRG (Cosmed) with Deltatrac II (Datex)

Detailed description: The aim of the present study is to compare the measured resting energy expenditure by Q-NRG (Cosmed) with Deltatrac II (Datex), in healthy volunteers.

Q-NRG is a new device. It is relevant to compare its results with the blog standard calorimeter, the Deltratrac II.

The study will include sports healthy subjects. The could benefit from the determination of their resting energy expenditure in order to adapt their nutritional intakes.

Eligibility criteria: Inclusion Criteria:

* healthy adult
* sport practice \> 1h per day at moderate intensity

Exclusion Criteria:

* refusal to participate
* unable to give a consent

Primary outcomes:
measure: resting energy expenditure
timeFrame: during the calorimetry
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Marjorie Fadeur
Study officials:
affiliation: University Hospital of Liège, Belgium
name: Anne-Françoise Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01260857: Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension
Official title: An Open Label, Observational, Post Marketing Surveillance Study To Assess The Safety And Efficacy Of The Spironolactone Plus Hydroflumethiazide (Aldazide) In The Treatment Of Filipino Patients With Stage 1 To 2 Hypertension
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Keywords: Spirinolactone
Hydroflumethiazide
Hypertension
Filipinos
Diabetes mellitus
Proteinuria
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients ages \>/= 18 years old with Stage 1 or 2 hypertension

Brief summary: Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively.

Detailed description: Prospective, non-interventional non-probability sampling

Eligibility criteria: Inclusion Criteria:

* Patients \>/= 18 years old with Stage 1 or 2 hypertension not controlled by monotherapy or by a combination of anti-hypertensives without any diuretic yet.

Exclusion Criteria:

* Pregnant or lactating women, with hypersensitivity to Aldazide, patients with resistant hypertension not controlled by a combination therapy with a diuretic in their regimen

Primary outcomes:
measure: Report of Adverse Events occurence (Safety)
timeFrame: 8 weeks
Secondary outcomes:
measure: Systolic BP in mmHg
timeFrame: 8 weeks
measure: Diastolic BP in mmHg
timeFrame: 8 weeks
measure: % of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02563457: Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients
Official title: Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetic patients
periodontal treatment
glycaemic control
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of periodontal treatment in diabetic patient. Patients will be randomized in the periodontal group or in the control group. The control group will received a periodontal treatment after the study.


Eligibility criteria: Inclusion Criteria:

* patient suffering from a periodontitis
* patient with : 7,0% \< Hemoglobin A1c \< 9,5%

Exclusion Criteria:

* If an hospitalization is planned within the next 4 months
* Patient suffering from chronic infectious pathology (HIV, hepatitis C virus, hepatitis B virus, mononucleosis)
* Renal insufficiency
* Contra indication for amoxicilline or clindamycin
* Antithrombotic treatment
* Liver disease

Primary outcomes:
measure: Hemoglobin A1c blood level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: fructosamine blood level
timeFrame: 3 weeks
measure: Quality of life
timeFrame: 3 months
Locations:
city: Bordeaux
country: France
facility: UH Bordeaux
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: UH Toulouse
name: Michel Sixou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06992557: Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol
Official title: Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol in the Mandibular Posterior Area a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Implant Stability
Low Speed Drilling
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower posterior mandible will the use of biological drilling protocol osteotomy compared to conventional drilling protocol osteotomy differ regarding implant stability at three months?


Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients, aged 21 to 60 years old,
* Indicated for delayed implant placement in the posterior mandibular arch.
* Good oral health.
* Willingness to sign the informed consent form.

Exclusion Criteria:

* Heavy smoker (\> 10 cigarettes/day)
* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* A history of radiotherapy in the head or neck region.
* Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation.

Primary outcomes:
measure: Implant stability (Implant Stability Quotient )
timeFrame: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical
Secondary outcomes:
measure: Crestal bone level changes
timeFrame: Measurements will be taken immediately post surgical and after 3 months post surgical
measure: Post-Operative Pain ( visual analogue scale)
timeFrame: 7 days post surgically
measure: Post-operative swelling (Verbal rating scale)
timeFrame: Swelling will be assessed 7 days post surgically
measure: Post-Operative patient's Satisfaction
timeFrame: 3 months post surgically
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university , faculty of dentistry
Study officials:
References:
Clinical trial NCT06450457: Effects of High Intensity Stepping Training on Gait in Patients With Ataxia
Official title: Effects of High Intensity Stepping Training on Gait in Patients With Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of high intensity stepping training on gait recovery, including walking speed and endurance, in patients with cerebellar ataxia. The hypothesis is that there will be a significant improvement in gait outcome measures (6 Minute Walk Test and 10 Meter Walk Test) in patients who receive high-intensity stepping training during physical therapy.


Eligibility criteria: Inclusion Criteria:

* diagnosis of ataxia
* admitted to The Institute for Rehabilitation and Research (TIRR) Texas Medical Center (TMC) Inpatient or TIRR Kirby Glenn Outpatient
* pathology that primarily affects the brain/cerebellum, including degenerative diseases, stroke, traumatic brain injury (TBI), posterior fossa tumor, and multiple sclerosis (MS)
* ambulatory at initial evaluation or will have functional ambulation goals at initial evaluation (as noted by 10 meter walk test and 6 minute walk test measures documented as 0)
* chronicity of injury will be of at least 1 month or greater

Exclusion Criteria:

* diagnoses that may have cerebellar involvement but without cerebellar ataxia as a principal impairment such as autism, down syndrome, schizophrenia, etc
* non ambulatory or who are not able to participate in high intensity stepping training due to cardiac involvement (such as cardiac rehabilitation parameters) or due to orthopedic limitations (such as weight bearing parameters)

Primary outcomes:
measure: Walking Speed in Meters Per Second as Assessed by the 10 Meter Walk Test(10MWT)
timeFrame: Baseline, 3 weeks
measure: Distance Walked in Feet as Assessed by the the Six Minute Walking Test (6MWT)
timeFrame: Baseline, 3 weeks
Secondary outcomes:
measure: Ataxia as Assessed by the Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: Baseline, 3 weeks
measure: Ability to Balance as Assessed by the Berg Balance Scale (BBS)
timeFrame: Baseline, 3 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kaitlin Benjamin, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05788757: Optetrak Knee System Post Market Clinical Follow-Up
Official title: A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Arthroplasty, Total
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 4588
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: Patients must qualify for surgery per indications and contraindications as well as meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.

Brief summary: A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

Detailed description: Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Eligibility criteria: Inclusion Criteria:

* Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
* Patient is skeletally mature
* Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary

Exclusion Criteria:

* Patient has a local or systemic infection
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant
* Patient has a mental or physical condition that may invalidate evaluation of the data - ---
* Patient is a prisoner
* Surgery is contraindicated according to the applicable product package insert

Primary outcomes:
measure: Knee Society Score
timeFrame: Preoperative
measure: Knee Society Score
timeFrame: 6 month postoperative
measure: Knee Society Score
timeFrame: annually through study completion, maximum of 10-years
measure: Hospital for Special Surgery Knee Score
timeFrame: Preoperative
measure: Hospital for Special Surgery Knee Score
timeFrame: 6 month postoperative
measure: Hospital for Special Surgery Knee Score
timeFrame: annually through study completion, maximum of 10-years
measure: Oxford Knee Score
timeFrame: Preoperative
measure: Oxford Knee Score
timeFrame: 6 month postoperative
measure: Oxford Knee Score
timeFrame: annually through study completion, maximum of 10-years
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Orthopaedic and Spine Center
state: Nevada
city: Charleston
country: United States
facility: Medical University South Carolina
state: South Carolina
Study officials:
References: