louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02777853: The Effect of Tea on Vascular Function and Insulin Sensitivity
Official title: Can Tea Prevent Impairments in Vascular Function and Insulin Sensitivity Induced by 7-days Physical Inactivity and Overfeeding in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: tea
cardiovascular
vascular
metabolism
microcirculation
physical inactivity
polyphenols
conduit artery
endothelial function
cerebrovascular
insulin sensitivity
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2016-05-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this research is to explore changes in peripheral/cerebrovascular function and insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and examine whether daily intake of tea can prevent such changes.

Detailed description: The aim of this study is to explore the impact of a 7-day 'unhealthy' lifestyle that combines physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) on peripheral (conduit artery and skin microvessels) and cerebrovascular function and insulin sensitivity in healthy male participants. Moreover, the investigators will explore whether the detrimental impact of this lifestyle can be mitigated by daily tea consumption (equivalent to 6 cups/day). To explore this hypothesis, the investigators will perform measurements of these parameters before and after 7-days of reduced physical activity and overfeeding, with and without the combination of daily tea ingestion.

Eligibility criteria: Inclusion Criteria:

* Aged 18-55 years
* Male
* Habitually active (\>8,000 steps/day)
* Healthy

Exclusion Criteria:

* Smokers
* Medical history of cardiovascular/metabolic disease
* Family history of cardiovascular disease (first degree relatives)
* On medication known to influence the cardiovascular system
* BMI of \<18 or \>30 kg/m2
* Known food allergies or special dietary requirements
* Vaccination (\<1 week) due to induced systemic inflammatory reaction

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Post 7 day intervention
Secondary outcomes:
measure: Vascular function
timeFrame: Post 7 day intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Sciences (RISES), Liverpool John Moores University
Study officials:
affiliation: Liverpool John Moores University
name: Kirsty A Woodward, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03333577: Evaluation of the Baha SoundArc in Pediatric Patients
Official title: Evaluation of the Baha SoundArc in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Hearing Loss, Unilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather clinical performance data on the Baha SoundArc

Detailed description: Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Eligibility criteria: Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months

* Subjects aged 5 through 12 years of age
* Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
* Willingness on behalf of the subject's parent or guardian to complete study questionnaire

Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol

-

Primary outcomes:
measure: Patient Satisfaction Survey
timeFrame: one month post fitting
measure: Percentage Correct on Word Identification Task
timeFrame: 4 weeks post fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Hearing and Balance
state: Arizona
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Fort Worth
country: United States
facility: Cook Children's Hospital
state: Texas
Study officials:
affiliation: Study Director
name: George Cire
role: STUDY_DIRECTOR
References:
Clinical trial NCT05631977: Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
Official title: Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis
Keywords: Point of care ultrasound
Echocardiography
Lead sponsor: Aisap LTD
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals under the care of the cardiology institutes of the participating sites, both inpatients and outpatient clinics and services.

Brief summary: The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 21 or more

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unstable clinical condition according to PI clinical judgment
2. Presence of prosthetic cardiac valve at any position and any type
3. Pregnancy or lactation
4. Contact isolation due to infections disease
5. Presence of left ventricular assist device (LVAD)
6. Know existence of congenital heart disease
7. Prosthetic cardiac valve, any
8. BMI 40 or greater
9. Clinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physicians
10. History of lung resection
11. Known poor cardiac US image quality based on prior echo exams
12. Mechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtained
13. Clinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant

Primary outcomes:
measure: POCUS QUALITY
timeFrame: 1 month
Secondary outcomes:
measure: Subgroup analysis
timeFrame: 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Fairfax
country: United States
facility: Inova Health
state: Virginia
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04333277: Lactobacillus Helveticus in the Treatment of Major Depression
Official title: Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.

Detailed description: Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10\^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years old;
* Diagnosis of major depression
* Agree to sign the informed consent.

Exclusion Criteria:

* Treatment with anti-inflammatory drugs or antibiotics of any pharmacological classes in the month before treatment enrollment;
* Use of dietary supplementation (herbal supplements, other pro- or prebiotics).

Primary outcomes:
measure: Change in the depressive symptoms severity
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in microbiota composition
timeFrame: 8 weeks
measure: Changes in the serum levels of biomarkers
timeFrame: 8 weeks
measure: Change in perception of stress
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Aline Silva de Miranda, PhD
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Érica Leandro Marciano Vieira
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Lais Bhering Martins
role: STUDY_CHAIR
References:
Clinical trial NCT02279277: Physical Therapy Prior to Total Knee Replacement
Official title: Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.


Eligibility criteria: Inclusion Criteria:

1. Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
2. Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
3. Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

1. Anyone who received physical therapy in the last 6 months
2. Inability to walk unaided for \>1 block
3. Currently engaged in regular PT or a regular home exercise program
4. Prior knee arthroplasty
5. Prior knee surgery for trauma, tumor and osteotomy
6. Injection given within 6 weeks of starting therapy
7. Patients using daily narcotic medications within prior 6 weeks

Primary outcomes:
measure: Range of Motion following Total Knee Replacement
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient reported perception of pain following total knee replacement
timeFrame: 6 weeks
measure: Return to functional activities following total knee replacement
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00498277: Quantitative Diffusion and Fat Imaging of the Spine
Official title: Quantitative Diffusion and Fat Imaging of Vertebral Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis
Magnetic Resonance Imaging
Vertebral Fractures
Quantitative Diffusion
Fat Imaging
Spine
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants with osteoporosis that have already been scheduled for MRI exams of the spine.

Brief summary: Primary Objective:

The purpose of this study is to determine whether or not combined quantitative diffusion and fat MR imaging techniques can differentiate between benign and malignant vertebral fractures.

Detailed description: Researchers believe that they may be able to use MRI scans to tell if fractures of the bones in the spine are due to cancer. They believe this can be done by looking at MRIs of diffusion (the random motion of molecules) and fat. For benign and malignant processes, either diffusion or fat, or both of them, can be different, because the cell density (which affects diffusion) and bone marrow content (which affects fat) are expected to be different.

All patients in this study will have already been scheduled for MRI exams of the spine at UTMDACC.

You will have one extra MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion. The extra time required for the study should be less than 10 minutes, and the total imaging time should fall within a standard MRI time slot.

Available data from your medical record, including imaging data, will be used to set up guidelines and clear examples for checking spinal fractures.

This is an investigational study. A total of 48 patients will take part in the study. All will be enrolled at UTMDACC.

Eligibility criteria: Inclusion Criteria:

1. Patients with suspected vertebral compression fractures scheduled a standard of care MRI of the spine.

Exclusion Criteria:

1. Patients who are contraindicated for MRI (such as due to metal implants, cardiac pacemaker).
2. Patients who are unable to give informed consent
3. Patients who are younger than 18 years of age since the disease (osteoporosis) is not present in children.

Primary outcomes:
measure: MRIs of diffusion (the random motion of molecules) and fat
timeFrame: One extra 10 minute MRI sequence during scheduled spine exam.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jingfei Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03798977: Preclinical Validation of New Anti-melanoma Compounds
Official title: Preclinical Validation of New Anti-melanoma Compounds: Study on Patient Melanoma Cells Sensitive and Resistant to BRAF/MEK Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Skin metastasis
Resistance
Endoplasmic reticulum stress
Metastasis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with metastatic melanoma

Brief summary: This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.


Eligibility criteria: Inclusion Criteria:

* Patient with metastatic melanoma
* Not opposition of the patient will have been looked for

Exclusion Criteria:

* Primary resistance,
* Absence of resistance,
* Patient already included in other trials

Primary outcomes:
measure: BRAF mutation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice hospital
Study officials:
References:
Clinical trial NCT04053777: Clinical Assessment Method in Patients Using Non-invasive Ventilation
Official title: Establishment and Validation of the Clinical Assessment Method in Patients Using Non-invasive Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypercapnic respiratory failure who need to use non-invasive ventilation.

Brief summary: This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Detailed description: Non-invasive positive pressure ventilation (NPPV) is undoubtedly one of the most important advances in mechanical ventilation technology in the past 30 years. Currently, NPPV has become an essential respiratory support technology in hospitals, and it is used in different fields, including respiratory and critical care, emergency care, anesthesia, and rehabilitation. Applications of NPPV are also gradually expanding from intensive care units (ICUs) and respiratory wards to use in other medical departments and at home.

This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80, males and females
2. Patients with hypercapnic respiratory failure
3. Willing to participate in the study.
4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
3. Subjects who participated in another trial within 30 days prior to the planned start of the study

Primary outcomes:
measure: Changes of visual analogue scale score before and after using non-invasive ventilation
timeFrame: 1 hour
Secondary outcomes:
measure: Changes of respiratory rate before and after using non-invasive ventilation
timeFrame: 1 hour
measure: Changes of SpO2 before and after using non-invasive ventilation
timeFrame: 1 hour
measure: Changes of tidal volume before and after using non-invasive ventilation
timeFrame: 1 hour
measure: Changes of heart rate before and after using non-invasive ventilation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Rongchang Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01352377: Impact of New CLSI Guidelines on Antibiotic Susceptability Pattern
Official title: A STUDY ASSESSING THE IMPACT OF THE NEW CLSI GUIDELINES ON ANTIBIOTIC SUSCEPTABILITY TESTING PATTERNS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic Susceptibility Patterns
Lead sponsor: University of Southern Nevada
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age more than 21 years who are inpatients at UMC.

Brief summary: Assessing the precise MIC for the Ceftriaxone using E-test. To determine what proportion of susceptibility reports will be reclassified based on the new CLSI guidelines.Antibiotic susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing Enterobacteriaceae organism generated by the Phoenix machine will be obtained on a daily basis.MIC for Ceftriaxone will be noted.If the MIC is \<=2 for Ceftriaxone,those cultures would be used to run an additional test - E- test.E-test gives us more precise MIC values compared to Phoenix machine.We will analyze the data collected over 2 months. We will determine the proportion of susceptibility reports reclassified based on the new CLSI guidelines.


Eligibility criteria: Inclusion Criteria:

* Antibiotic susceptibility reports of blood cultures, urine cultures,aseptic body fluid cultures growing Enterobacteriaceae organism generated by the Phoenix machine.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Umc
state: Nevada
Study officials:
References: