louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04198194: Apple Heart & Movement Study
Official title: Apple Heart & Movement Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prevention
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: American Heart Association
First posted: 2019-12-13
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will self-enroll in this trial, if they meet inclusion criteria, and there will be no active recruitment of any particular population. Invitation to volunteer.

Brief summary: This study will look for factors that affect heart health and potentially cause deterioration in mobility or heart function. Participant's Apple Watch and iPhone can help researchers gain a better understanding of potential early warning signs. This can lead to new interventions and products that will help millions lead longer, healthier, and more active lives.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
* Live in the United States of America;
* Have an iPhone;
* Have an Apple Watch (Series 1 or later) at the time of enrollment;
* Have the Apple Research app installed on your iPhone;
* Be comfortable communicating in written and spoken English;
* Not share your iCloud account, iPhone, or Apple Watch with anyone else;
* Be willing and able to provide informed consent to participate in the study.

Primary outcomes:
measure: Number of Participants with Chronic Disease Events
timeFrame: quarterly (every 90 days) through study completion (up to 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: cmacrae@bwh.harvard.edu
name: Calum A MacRae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: amspillane@bwh.harvard.edu
name: Angela M Spillane
role: STUDY_DIRECTOR
References:
Clinical trial NCT05041894: Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography
Official title: Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke With Tracheotomy : Assessment by Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Diaphragm Injury
Tracheostomy
Keywords: The stroke patients with tracheotomy
Diaphragm excursion
Diaphragm thickness
Ultrasonography
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .

Brief summary: The purpose of this study was to examine whether if the effect of standing with assistance of the tilt table on diaphragm excursion and thickness in the stroke patients with tracheotomy.

Detailed description: 40-45 stroke patients with tracheotomy were passive tilting (α=0°, 30°, 60°) by an electric tilt table in the random order. The diaphragm excursion and thickness were measured by ultrasonography on three tilting during the quiet breathing. Besides, the intraclass correlation coefficient (ICC) were calculated to assess the reliability of the diaphragm ultrasonography in this population.

Eligibility criteria: Inclusion Criteria:

1. currently diagnosed with ischemic or hemorrhagic stroke by CT or MRI;
2. right unilateral or bilateral limb with hemiparesis;
3. age over 18 years;
4. BMI\<35 kg/m2;
5. within 2 weeks to 12 months；
6. the tracheotomy tube replacement;
7. non first time standing assisted with tilt table.

Exclusion Criteria:

1. undergoing mechanical ventilation;
2. postural hypotension;
3. myocardial infarction in the first 3 months;
4. deep vein thrombosis;
5. angina or acute heart failure;
6. complicated with other primary pulmonary diseases, such as tuberculosis,；pneumothorax, and chronic obstructive pulmonary disease and so on;
7. a past episode of abdominal or chest surgery.

Primary outcomes:
measure: Diaphragm excursion
timeFrame: Half an hour
measure: Diaphragm thickness
timeFrame: Half an hour
Secondary outcomes:
measure: The intraclass correlation coefficient (ICC)
timeFrame: Within-24h
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
Study officials:
References:
Clinical trial NCT01290094: A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Official title: Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-04
Enrollment: 41
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.


Eligibility criteria: Inclusion Criteria:

* Female patients, \> 50 years of age
* Diagnosed osteoporosis
* Bone mineral density \< minus 2.5 SD or osteoporotic fracture
* At least 3 years after menopause

Exclusion Criteria:

* Impaired renal function
* Contra-indication to Calcium or Vitamin D therapy
* Previous or current treatment with biphosphonates

Primary outcomes:
measure: Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
timeFrame: Baseline, Month 24
measure: Percent Change From Baseline in Mean Hip Bone BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Mean Hip BMD at Month 24
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24
timeFrame: Baseline, Month 12, Month 24
measure: Percent Change From Baseline in Total Hip T-score at Month 12 and 24
timeFrame: Baseline, Month 12, Month 24
measure: Percentage of Participants Who Received All Planned Study Medication (Compliance)
timeFrame: Baseline up to Month 12
measure: Correlation Coefficient of Participant's Profile With Compliance
timeFrame: Baseline up to Month 12
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
city: Sarajewo
country: Bosnia and Herzegovina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03069794: Effect of Spinal Surgery on the Posture and the Balance of the Patients Reached of Spinal Pathologies
Official title: Effect of Spinal Surgery on Stable Force Platform Parameters Estimating the Posture and the Balance of the Patients Reached of Spinal Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Surgery
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Many studies are in favour of the importance of the rachis on the postural balance of the body.It is possible to study the upright posture by determining the center of pressure using a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By deformation correction and stabilizing vertebral stages via arthrodesis, it seems to hypothesize that surgery can modify postural balance.

This study aim to evaluate spinal surgery effect on posture using that plaftorm .

Detailed description: At the inclusion, Day 1 and day 2 after surgery, the patient will stand on the stabilometric platform, with arms extended along the body, barefoot at 30 ° with a 2 cm gap at the heels.

He will fix a target located 1 meter away from him, in silence and will be instructed to "stand as still as possible, with his arms along his body, look in the direction of the visual target, do not think about anything. ". Then there will be a collection of data in 3 shots of 90 seconds, with a rest period between each shot, using the Winposture® software. The patient will answer health related quality of life questionnaires.

6 months after inclusion, patients will answer health related quality of life questionnaires.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old
* Patient programmed for spinal surgery
* Patient accepting participation

Exclusion Criteria:

* Refusal of participation
* All patient with vestibular disease
* All patient with neurologic disease
* Patient with pathologies not allowing to maintain the prolonged standing.

Primary outcomes:
measure: Center of foot pressure (COP) positions
timeFrame: Day 1- Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Groupe Hospitalier Paris St Joseph
name: Romain Clquin
role: STUDY_DIRECTOR
affiliation: Groupe Hospitalier Paris St Joseph
name: Stéphane WOLFF, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04407494: Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)
Official title: Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2
COVID-19
Diagnostic value
Sensitivity
Specificity
Prevalence
Positive predictive value
Negative predictive value
Epidemiology
Diagnostic test
Anosmia
Ageusia
Olfactory disorders
Gustatory disorders
Smell disorders
Taste disorders
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.

Brief summary: Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.


Eligibility criteria: Inclusion criteria:

* Symptoms compatible with COVID-19
* Close exposure to a confirmed COVID-19 index case
* Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus with initial mild disease)

Exclusion criteria:

* known history of smell and taste disorders
* testing inability (cognitive impairment, non native French speakers, test malingering)
* testing contraindication (children, pregnancy, breastfeeding, specific allergies).

Primary outcomes:
measure: Diagnostic values of anosmia and ageusia for COVID-19
timeFrame: at inclusion
Secondary outcomes:
measure: Diagnostic values of CODA
timeFrame: at inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Fréderic VENAIL, PU-PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03453294: Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers
Official title: Effect of Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) During Apneic Oxygenation in General Anesthesia on Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Oxygen Toxicity
Keywords: THRIVE
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 30
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: Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Adults, \>18 years old.
2. Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

1. American Society of Anaesthesiologist severity score \>2
2. New York Heart Association score \>2
3. Pacemaker or ICD.
4. Body Mass Index \>35
5. Pregnancy
6. Manifest cardiac failure or coronary disease
7. Severe gastrointestinal reflux.
8. Neuromuscular disorder

Primary outcomes:
measure: Oxidative stress
timeFrame: Up to 2 hours after start of intervention
Secondary outcomes:
measure: Biomarkers of neuronal injury
timeFrame: Up to 2 hours after start of intervention
measure: Biomarkers of cardiac damage
timeFrame: Up to 2 hours after start of intervention
measure: Biomarkers of kidney injury
timeFrame: Up to 2 hours after start of intervention
measure: Markers of RNA damage
timeFrame: Up to 2 hours after start of intervention
measure: Inflammatory response
timeFrame: Up to 2 hours after start of intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT02779894: Sleep Apnoea Management by a Communication Based Technology (ICT)
Official title: Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Telemedicine
Keywords: Sleep Apnea
Communication Based Technology
ICT
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).

Detailed description: Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity resulting in long waiting lists and high health care costs. Therefore, alternative cost-effective approaches are urgently needed. A possible procedure is telemedicine based on ICT.

The design of the study is prospective, randomized, controlled, open and parallel.

A ICT-based out of hospital management of SAHS is implemented to be compared with the classical in-hospital management.

The main objectives were the evaluation of both groups and the analysis of efficacy and cost effectiveness of two SAHS management programs.

This is a 3 month randomized, with parallel groups study. Participants will be patients with suspicion of SAHS derived to the Investigators' Sleep Unit.

Patients are randomized in two groups; 1) classical in-hospital group: polysomnography or home respiratory polygraphy (HRP), CPAP titration and treatment and hospital follow-up; and 2) ICT group: 3 consecutive HRPs, automatic CPAP treatment and control by phone/video conferences and data transmission by using a custom designed platform.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of SAHS
* Use of Smartphone and internet

Exclusion Criteria:

* Severe hypersomnia
* Central apneas or other sleep disorder
* Previous CPAP treatment
* Unstable diseases
* Profession of risk
* Not able to complete questionnaires
* No written informed consent

Primary outcomes:
measure: Evaluation of the two SAHS management programs
timeFrame: 3 months
measure: Evaluation of the two SAHS management programs
timeFrame: 3 months
Secondary outcomes:
measure: Cost-effectiveness of the two SAHS management programs
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic
name: Josep M Montserrat
role: STUDY_DIRECTOR
References:
Clinical trial NCT05945394: The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human
Official title: The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Heart Disease, Susceptibility to, 1
Keywords: TRAF3IP2, Coronary angiography, coronary deart disease
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected coronary heart disease who experienced coronary angiography

Brief summary: To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human

Detailed description: Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients with suspected coronary heart disease
2. patients received coronary angiography

Exclusion Criteria:

1. NYHA III-IV
2. malignant tumor
3. acute infection
4. thyroid dysfunction

Primary outcomes:
measure: stenosis of coronary artery
timeFrame: 1 week
Secondary outcomes:
measure: coronary artery calcium
timeFrame: 1 week
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
Study officials:
affiliation: NJMU
name: Ma Shuren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05400694: Functional and Value-Added Dairy Products and Blood Glucose Control
Official title: The Sensory and Metabolic Effects of Functional and Value-Added Dairy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose, High
Metabolic Disease
Overweight and Obesity
Keywords: Sugar intake
Sweeteners
Milk Proteins
Diabetes
Obesity
Sweetened food products
Chocolate milk
Blood glucose
Insulin
Satiety
Food Intake
Casein
Whey protein
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2022-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Milk proteins possess multiple biological activities including their effect on blood glucose control, satiety and energy intake. The design of functional food products with added milk protein fractions has many challenges related to their inferior sensory properties. Chocolate milk presents the universal vehicle for added milk protein fractions that might partially mask their sensory characteristics. However, commercially produced chocolate milk has a significant amount of added sugar. This project will investigate the properties of a value-added dairy product (chocolate milk with reduced sugar content) enriched with individual milk protein fractions on characteristics of blood glucose control, satiety and energy intake in young healthy adults.


Eligibility criteria: Inclusion Criteria:

* 19-35 y males and females, non-smokers

Exclusion Criteria:

* having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.

Primary outcomes:
measure: Blood glucose
timeFrame: 0-120 minutes
measure: Insulin
timeFrame: 0-120 minutes
Secondary outcomes:
measure: C-peptide
timeFrame: 0-120 minutes
measure: Incretins, glucagon and amino acids
timeFrame: 0-120 minutes
measure: Satiety
timeFrame: 0-120 minutes
measure: Food Intake
timeFrame: 0 min, 120 minutes
measure: Thirst
timeFrame: 0-120 minutes
measure: Physical comfort
timeFrame: 0-120 minutes
measure: Food pleasantness
timeFrame: at 0 and 120 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: Mount Saint Vincent University
name: Bohdan Luhovyy, PhD
role: PRINCIPAL_INVESTIGATOR
References: