louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04005911: Non-Contact Respiratory Rate Monitoring
Official title: Evaluation of Non-Contact Respiratory Rate Monitor in Post-Surgical Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxia
Keywords: Post-surgical
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-surgical patients in the PACU at the University of Virginia

Brief summary: The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.


Eligibility criteria: Inclusion Criteria:

* Underwent surgery at the University of Virginia
* Able to provide verbal consent to participate in the study

Exclusion Criteria:

* Unable to provide verbal consent to participate in the study
* Youth
* Prisoners

Primary outcomes:
measure: Agreement between manually calculated respiratory rate and thermographic respiratory rate
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT01477411: A Drug-Drug Interaction Study of Digoxin and PA21
Official title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Digoxin in Healthy Male and Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction Potentiation
Keywords: Drug-drug interaction
Pharmacokinetics
PA21
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if Digoxin is affected by PA21.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy

Primary outcomes:
measure: Area Under the Curve from time zero to 24 hours (AUC0-24)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22
measure: Area Under the Curve from time zero to infinite (AUC0-infinity)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22
measure: Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACRI - Phase 1
state: California
Study officials:
affiliation: ACRI - Phase 1 (Advanced Clinical Research Institute)
name: Peter Winkle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021111: The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Official title: The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Sprains and Strains
Wounds and Injuries
Knee Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with ACL injuries.

Detailed description: This study will address the following specific aims: 1) To optimize a wearable, targeted, active training feedback device to reduce the risk of ACL injury among healthy subjects by inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries. 2) To evaluate the efficacy of the active device and determine if the device reduces the risk of ACL injury among healthy subjects by effectively inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries.

Eligibility criteria: Inclusion Criteria:The ages would range from 18 to 65. Both male and female subjects will be enrolled, and ethnic backgrounds would be mixed. Exclusion Criteria:(i) chronic lower body pain (ii) recent surgery of the lower or upper body (limitation of range of motion) (iii) previous history of ligament, meniscal, or chondral injury requiring surgery to the lower limb (iv) inability to complete jumping tasks

Primary outcomes:
measure: Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback
timeFrame: 1 day
Secondary outcomes:
measure: Thigh Coronal Angular Velocity After Feedback Training
timeFrame: 1 day
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Thomas Peter Andriacchi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01031511: Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders
Official title: A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Anxiety
Keywords: High-Functioning Autistic Spectrum Disorder
Anxiety
Cognitive Behavioural Therapy
Social Recreational
Parent Stress
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
Collaborators: name: Nanyang Technological University
name: Autism Resource Centre, Singapore
First posted: 2009-12-14
Enrollment: 73
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.


Eligibility criteria: Inclusion Criteria:

* Assessed to have Autistic Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder, Not Otherwise Specified by the DSM-IV criteria, based on clinical interview, Asperger Syndrome Diagnostic Scale (ASDS) or Autism Diagnostic Observation Schedule (ADOS)
* Child have a Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and above
* No change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study
* Written parental consent and assent from children above 12 years old

Exclusion Criteria:

* Children with Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and below.
* Children who are undergoing other Cognitive Behavioural treatment program concurrently
* Those without parental consent will not be able to participate

Primary outcomes:
measure: Anxiety level of child
timeFrame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Secondary outcomes:
measure: Parent Stress Level
timeFrame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health, Singapore
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Min Sung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470611: Sodium Alendronate in Non Surgical Periodontal Therapy
Official title: Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Bone Resorption
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Pontifícia Universidade Católica de Minas Gerais
First posted: 2015-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.


Eligibility criteria: Inclusion Criteria:

* chronic periodontitis
* two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss \> 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
* systemically healthy volunteers

Exclusion Criteria:

* need for antibiotic or systemic/local antibiotic use in the previous 3 months
* periodontal treatment in the previous 6 months
* pregnancy or lactation
* immunological disorders or imune suppressive treatments
* diabetes
* smoking
* orthodontic appliances or removable prosthesis
* osteoporosis
* known or suspected allergy to biphosphonates
* systemic use of biphosphonates

Primary outcomes:
measure: Changes in pocket depth
timeFrame: baseline and 3- and to 6-month evaluations
measure: Changes in clinical attachment level
timeFrame: baseline and 3- and to 6-month evaluations
Secondary outcomes:
measure: Changes in bone defects
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Dental clinic of pontifical catholic university
state: Minas Gerais
Study officials:
affiliation: Head of Periodontology
name: Fernando O Costa, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06846411: The EMPA-FIT Study
Official title: Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type II
Keywords: Metformin, empagliflozin, glucose variability
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.

Exclusion Criteria:

* individuals with a body mass index (BMI) \<18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR \<60 mL/min/1.73 m²) or end-stage renal disease (eGFR \<15 mL/min/1.73 m² or on dialysis) were also excluded.

Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (\>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides \>1,000 mg/dL or LDL cholesterol \>250 mg/dL).

Primary outcomes:
measure: mean amplitude of glucose excursion (MAGE)
timeFrame: 24 weeks
Secondary outcomes:
measure: SD of glucose
timeFrame: 24 weeks
measure: Time in range (TIR)
timeFrame: 24 weeks
measure: Mean Blood Glucose (MBG)
timeFrame: 24 weeks
measure: Glucose Management Indicator (GMI)
timeFrame: 24 weeks
measure: Coefficient of Variation (CV)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: SNUBH
Study officials:
References:
Clinical trial NCT04867811: Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Official title: Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old.

Detailed description: They were divided randomly into three groups by lottery method. Group A (n=30) received conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group C received cupping therapy with conventional therapy and group D (n=30) received TENS and cupping therapy plus conventional therapy. All patients read and signed a consent form before participation in this trial. This study was approved by the Ethical Committee of the Faculty of Physical Therapy, October 6 University, Egypt. Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months were included in the study while patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin were excluded from this study.

Eligibility criteria: Inclusion Criteria:

- Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months

Exclusion Criteria:

* patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
measure: Pain-Free Grip Strength
timeFrame: 4 weeks
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qaliubia
country: Egypt
facility: Bassam
Study officials:
References:
Clinical trial NCT05117411: Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema
Official title: Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakic Cystoid Macular Edema
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 18 years with diagnosis of pseudophakic cystoid macular oedema. The participans did not present other ophthalmological diseases.

Brief summary: This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography

Detailed description: Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery.

It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.

Eligibility criteria: Inclusion Criteria:

* age older than 60 years
* diagnosis of pseudophakic cystoid macular oedema
* treatment-naïve for pseudophakic cystoid macular oedema
* absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Exclusion Criteria:

* age younger than 60 years
* No diagnosis of pseudophakic cystoid macular oedema
* previous treatment for pseudophakic cystoid macular oedema
* presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Primary outcomes:
measure: OCTA and pseudophakic cystoid macular oedema
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università Federico II
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289011: Spondyloarthritis and Nutrition
Official title: Spondyloarthritis and Nutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthrosis
Nutrition Disorders
Keywords: Spondyloarthrosis
Nutrition Disorders
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with axial or peripheral spondyloarthritis

Brief summary: The food composition and consumption of certain foods could be associated with a higher or lower inflammatory activity of spondyloarthritis and consequently changes in the quality of life of patients. This has been shown in other chronic inflammatory disease.

In order to highlight a profile or nutritional profiles associated with the activity of the disease, we chose to carry out observational pilot study using a qualitative food survey, which will be submitted to all patients with spondyloarthritis. The general demographic data and the data of the disease will be collected by the investigating physician at the same time, as well as possible confounding factors: comorbidities, physical activity, treatments.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who meet the ASAS criteria for axial or peripheral spondyloarthritis
* Patients agreeing to participate and not objecting to the use of their personal data

Exclusion Criteria:

* Presence of Inflammatory bowel disease: Crohn's or RCH diagnosed
* History of bariatric surgery
* Patient subject to a court order, guardianship or trusteeship
* Patient unable to complete questionnaire

Primary outcomes:
measure: Nutritional survey
timeFrame: Day 0
measure: Disease activity
timeFrame: Day 0
Secondary outcomes:
measure: Physical activity
timeFrame: Day 0
measure: Assess the quality of life
timeFrame: Day 0
measure: Digestive symptoms
timeFrame: Day 0
measure: Fatigue
timeFrame: Day 0
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References:
Clinical trial NCT06227611: Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients with Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.
Official title: Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients with Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma patients referring to glaucoma clinic of IRCCS-Fondazione GB Bietti and University of Rome Tor Vergata.

Brief summary: The aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness.


Eligibility criteria: Inclusion Criteria:

* glaucoma patients with glaucomatous optic nerve head defect and reduced ganglion cell layer thickness

Exclusion Criteria:

* age\<18 years
* unable to read, understand and sign the written informed consent
* unable to perform visual field test
* advanced glaucoma with C/D\>0.7
* other causes of optic neuropathies
* retinal or macular diseases
* lens or corneal opacities
* spherical refractive defect \>± 6D
* cylindric refractive defect \>± 3D

Primary outcomes:
measure: the agreement between 10-2 HFA and 24-2c HFA in detecting central visual field defect
timeFrame: 12 month
Secondary outcomes:
measure: the agreement between 24-2c HFA and G1 Octopus in detecting central visual field defect
timeFrame: 12 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS-Fondazione GB Bietti
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References: