louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06028139: Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Official title: Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Sengkang General Hospital
name: National Heart Centre Singapore
First posted: 2023-09-08
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).


Eligibility criteria: Inclusion Criteria:

* Aged 21 years and above
* Have diagnosis of type 2 diabetes mellitus
* Provided informed consent
* Have near-field communication (NFC) compatible phones
* Able to engage in light physical activity (e.g., walking)

Exclusion Criteria:

* Significant cognitive impairment
* Other conditions that may preclude participants from wearing CGM devices

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Physical activity as measured by number of steps
timeFrame: 6 months
measure: Physical activity as measured by moderate to vigorous active minutes
timeFrame: 6 months
measure: Physical activity as measured by GPAQ
timeFrame: 6 months
measure: Diet as measured by DASH
timeFrame: 6 months
measure: Sugar sweetened beverages intake
timeFrame: 6 months
measure: Patient activation score as measured by patient activation measure
timeFrame: 6 months
measure: Medication adherence as measured by DOSE-Nonadherence scale
timeFrame: 6 months
measure: Quality of life as measured by EQ-5D-5L
timeFrame: 6 months
measure: Healthcare cost as measured by cost of consultations, lab tests, medications, admission
timeFrame: 6 months
measure: Healthcare cost as measured by WPAI
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
References:
Clinical trial NCT02358239: Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Vertigo
Keywords: dizziness and vertigo
emergency department (ED)
clinical trial
acupuncture
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed assess the feasibility of applying acupuncture as an emergent intervention means to the treatment of dizziness and vertigo. The investigators study targeted on filling in this gap by performing a clinical control trial to evaluate the efficacy and safety of traditional Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.


Eligibility criteria: Inclusion Criteria:

* Visit emergency department and stay in observation unit.
* Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis.

Exclusion Criteria:

1. Serious comorbid conditions (for example, life-threatening condition or progressive central disorder).
2. Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.

Primary outcomes:
measure: Visual Analog Scale (VAS) of dizziness
timeFrame: after the first 30 minutes after acupuncture
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chiu CW, Lee TC, Hsu PC, Chen CY, Chang SC, Chiang JY, Lo LC. Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study. BMC Complement Altern Med. 2015 Jun 9;15:173. doi: 10.1186/s12906-015-0704-6.
Clinical trial NCT06124339: Brain Health Virtual Reality Study
Official title: Interventions to Promote Brain Health Virtual Reality Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Aging Problems
Memory Loss
Memory Impairment
Memory Disorders in Old Age
Memory Disorder, Spatial
Memory Disorders
Mild Cognitive Impairment
Cognitive Decline
Cognitive Change
Cognition Disorders in Old Age
Keywords: Virtual Reality
technology
intervention
exercise
cycling
memory
brain health
aging
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.


Eligibility criteria: Inclusion Criteria:

1. 50-85 years of age
2. Fluent in English
3. Can safely ride a stationary bike

Exclusion Criteria:

1. Dementia
2. History of a neurological disorder
3. Severe sensory deficits
4. Inability to perform intervention (e.g., inability to cycle safely)
5. Contraindications to MRI scan (e.g., pacemaker)
6. Fear of needles/ blood
7. Prior history of fainting due to sight of needles of blood

Primary outcomes:
measure: MST memory performance
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT05496439: Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction
Official title: Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: visceral fat area
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 172
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 with heart failure with preserved ejection fraction

Brief summary: Study of the prognosis of patients with heart failure with preserved ejection fraction

Detailed description: Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.

Eligibility criteria: Inclusion Criteria:

1. Adult aged \>=18years old;
2. Diagnosed with HFpEF.Diagnostic criteria including:

1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； 4）at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

1. Age \<18 years old；
2. LVEF less than 45% at any time;
3. cancer diagnosis.

Primary outcomes:
measure: death
timeFrame: The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
References:
Clinical trial NCT02308839: GORE® EXCLUDER® Endoprosthesis French Mandatory Registry
Official title: Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Aneurysm
Aorta
Abdominal
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 181
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 requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Brief summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

Detailed description: The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Eligibility criteria: Inclusion Criteria:

* Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Exclusion Criteria:

* Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).

Primary outcomes:
measure: Percentage of Participants Survived at 5 Years
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of Participants Free From Endoleak at 5 Years
timeFrame: 5 years
measure: Percentage of Participants Free From Migration at 5 Years
timeFrame: 5 years
measure: Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years
timeFrame: 5 years
measure: Percentage of Participants Free From Aneurysm Related Mortality at 5 Years
timeFrame: 5 years
measure: Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years
timeFrame: 5 years
measure: Percentage of Participants Free From Surgical Conversion at Procedure
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier de Dijon
Study officials:
affiliation: Centre Hospitalier Universitaire du Bocage
name: Eric Steinmetz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04855539: Coronavirus: Ventilator Outcomes Using Artificial Intelligence Chest Radiographs & Other Evidence-based Co-variates
Official title: Coronavirus Infectious Disease 2019: Ventilator Outcomes Using Artificial Intelligence, Chest Radiographs and Other Evidence-based Co-variates (COVID VOICE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Pneumonia
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2021-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults with COVID-19 at secondary and tertiary centres

Brief summary: We will determine ventilator outcomes to Coronavirus Infectious Disease 2019 (COVID-19) using artificial Intelligence with inputs of chest radiographs and other evidence-based co-variates.

Detailed description: The chest radiograph (chest x-ray) has emerged as the United Kingdom's National Health Service (NHS) frontline diagnostic imaging test for COVID-19, in conjunction with clinical history and key blood markers: C-reactive protein (CRP) and lymphopenia. Typically, every suspected COVID-19 patient presenting to the emergency department is undergoing blood tests and a chest radiograph. Therefore, it has become critical for radiologists to review and "hot" report the chest x-ray urgently.

Primary Objective: Use chest radiographs and clinical data to determine whether patient can survive with a ventilator

Eligibility criteria: Inclusion Criteria:

Admitted to intensive care unit (ITU) or equivalent COVID-19 polymerase chain reaction (PCR) positive

Exclusion Criteria:

No imaging prior to ITU admission

Primary outcomes:
measure: Sensitivity and specificity of a convolutional neural network to predict survival outcome
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Orpington
country: United Kingdom
facility: Princess Royal University Hospital
state: Kent
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References:
Clinical trial NCT05447039: Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
Official title: Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19
Keywords: Montelukast
cough
cough severity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: As of September 2020, the COVID-19 pandemic has affected millions of people in 196 countries and left hundreds of thousands dead. After recovery it was found that up to 32% of cases had 1 or 2 symptoms, 55% had 3 or more Post-COVID-19 symptoms, and persistent Post COVID-19 cough was recorded in 29.3% of cases in one study.

A recent study identified Montelukast, among the top-scoring clinically-oriented drugs likely to inhibit SARS-CoV-2 main protease. Besides its known effect that is reported to improve cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed Montelukast in the treatment of post-infectious cough and found variable effects.

Despite that the exact mechanism is not yet identified, Barré and colleagues proposed several properties of Cyst LT1 receptor antagonists that are potentially beneficial in COVID-19.


Eligibility criteria: Inclusion Criteria:

* Patients with Post COVID-19 persistent cough after 4 weeks of acute attack

Exclusion Criteria:

* Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.

Primary outcomes:
measure: cough severity index
timeFrame: 14 days
measure: Cough severity visual analog
timeFrame: 14 days
Secondary outcomes:
measure: Side effects of drug
timeFrame: 14 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliae Mohamed-Hussein
Study officials:
References:
Clinical trial NCT01160939: Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Official title: Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Exercise
heart failure
rehabilitation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 21
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: To study the behavior and cardiovascular safety protocol to the front low-intensity exercise in patients with heart failure (HF) severe, awaiting heart transplantation. Methods: The investigators studied 21 patients with severe HF on the list for a heart transplant at the University Hospital of UNIFESP. After evaluation, patients underwent exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3. walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between 2-6 metabolic equivalents. These also were followed for an average period of 17 months as the clinical complications and death. Results: From the patients studied, three were not able to perform the full protocol, and the variables body mass index, maximal inspiratory and expiratory pressure measurement (Pimáx and Pemáx, cmH2O) and number of previous admissions, showed the most divergent behavior of the sample studied. A greater increase in heart rate, double product and scale of perceived exertion during step 5 was observed during the protocol. Blood pressure levels showed little change between stages, and there was no arrhythmias incidence increase (kappa = 0.552) compared to effort. A positive correlation scale was perceived in exertion walking distance of 200m, with systolic blood pressure (r = 0.4, p = 0.02). Overall observed lower values of maximal inspiratory pressure and increased blood pressure and elevated heart rate in patients with death outcome. Conclusion: Cardiovascular behavior against exercise protocol was well tolerated and safe, but suggests need for monitoring. Information collected at initial clinical evaluation associated with decompensation and death, and may help stratify these patients.


Eligibility criteria: Inclusion Criteria:

* heart failure severe, awaiting heart transplantation

Exclusion Criteria:

* decompensated heart failure
* vasoactive drugs
* unstable angina
* severe stenosis or insufficiency valvular
* recent surgery
* morbid obesity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
References:
Clinical trial NCT05205239: Small Bowel Motility in Patients With Systemic Sclerosis
Official title: Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: System Sclerosis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.


Eligibility criteria: Inclusion Criteria:

* Systemic sclerosis diagnosed by ACR criteria

Exclusion Criteria:

* Lung transplantation
* End stage kidney disease

Primary outcomes:
measure: Motility index score
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Malagelada C, Drozdzal M, Segui S, Mendez S, Vitria J, Radeva P, Santos J, Accarino A, Malagelada JR, Azpiroz F. Classification of functional bowel disorders by objective physiological criteria based on endoluminal image analysis. Am J Physiol Gastrointest Liver Physiol. 2015 Sep 15;309(6):G413-9. doi: 10.1152/ajpgi.00193.2015. Epub 2015 Aug 6.
citation: Segui S, Drozdzal M, Pascual G, Radeva P, Malagelada C, Azpiroz F, Vitria J. Generic feature learning for wireless capsule endoscopy analysis. Comput Biol Med. 2016 Dec 1;79:163-172. doi: 10.1016/j.compbiomed.2016.10.011. Epub 2016 Oct 19.
citation: Malagelada C, Bendezu RA, Segui S, Vitria J, Merino X, Nieto A, Sihuay D, Accarino A, Molero X, Azpiroz F. Motor dysfunction of the gut in cystic fibrosis. Neurogastroenterol Motil. 2020 Sep;32(9):e13883. doi: 10.1111/nmo.13883. Epub 2020 May 31.