louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01376011: Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement
Official title: Hypoxia-inducible Transcription Factor 1 (HIF-1) in Vascular Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Problem of Aging
Keywords: quercetin
brain blood flow
aging
memory
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-06-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if quercetin can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers between the ages of 18-75 years old

Exclusion Criteria:

* subjects taking vasoactive medications
* hypertension or vascular disease
* asthma
* smokers
* pregnant women
* cancer
* diabetes mellitus
* history of seizures
* history of stroke or head trauma
* subjects taking digoxin, cyclosporine,felodipine, estradiol, or quinolone antibiotics
* poor transcranial Doppler insonation windows

Primary outcomes:
measure: Define change from baseline levels of HIF-1 concentration and 3 of its regulated proteins after 6 months of quercetin (versus placebo) dietary intake.
timeFrame: 6 months
measure: Determine change from baseline brain blood flow after 6 months of quercetin (versus placebo) dietary intake.
timeFrame: 6 months
Secondary outcomes:
measure: Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake.
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Farzaneh Sorond, mD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018811: Psychological Assessment and Treatment of Chronic Benign Headache
Official title: Psychological Assessment and Treatment of Chronic Benign Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Tension Headache
Stress Headache
Vascular Headache
Keywords: Relaxation Techniques
Behavior Therapy Feedback
Psychophysiology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback or relaxation training after fulfilling screening, intake interviews, \& psychological testing requirements. They will chart headache pain, anger level, \& medication usage throughout baseline, treatment, and 3 month follow-up periods.

Migraine sufferers will receive a combination of progressive muscle relaxation training and thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive treatment either in the office with the therapist or from another room (where communication will be over a computer). The research is designed to compare the effectiveness of treatment based on location.

Tension headache sufferers will receive training in how to reduce their muscle tension levels. They will be randomly assigned to have equipment monitor muscle tension levels either in the forehead or shoulder regions. The research is designed to compare the effectiveness of feedback to the forehead versus the shoulder muscles.


Eligibility criteria: Subjects must be at least 18 years old and have chronic headaches of any of the following types: migraine, coexisting migraine/tension, or tension. Participants must be intellectually intact and have no significant physical, neurological, or psychological problems. They must have seen a physician for their headaches within the past year. They must successfully complete screening/interview/testing process prior to admission to treatment.

All vascular headache subjects must meet the criteria for chronic migraine or coexisting migraine and tension type headache as set forth by the Headache Classification Committee of the International Headache Society.

All tension headache subjects must meet the criteria for either episodic or chronic tension headache set forth by the Headache Classification Committee, as well as the Ad Hoc Committee's criteria for tension headache.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Department of Veterans Affairs Medical Center
state: Georgia
Study officials:
References:
Clinical trial NCT06728111: Unraveling Perioperative Myocardial Injury
Official title: unRaveling pErioperative MyocArdial INjury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Injury
Myocardial Injury After Non-Cardiac Surgery
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 1114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population to be studied consists of all non-cardiac surgical patients who underwent surgery at Erasmus MC in the period 2017-2023.

Brief summary: The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Age \> 18 year of age
* Undergoing non-cardiac surgery in the Erasmus MC, with (high-sensitive) Troponin T \> 50 ng/L measured in any of the first three days after surgery.

Exclusion Criteria:

* Re-operations within the study period.
* Daycare surgery

Primary outcomes:
measure: Main etiologies elevated troponin T
timeFrame: from enrollment
Secondary outcomes:
measure: Differences in adjudication
timeFrame: from enrollment
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Epidemiologist
name: Sanne Hoeks, PhD
role: STUDY_DIRECTOR
affiliation: Anesthesiologist
name: Felix van Lier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03257111: Activity Levels and Rehabilitation Outcomes of Patients Post-stroke
Official title: The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: rehabilitation outcomes
activity level
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
Collaborators: name: Brookdale Center for Healthy Aging & Rehabilitation
First posted: 2017-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include only people with a diagnosis of stroke who have been admitted to the in-patient rehabilitation facility "Brookdale Center for Healthy Aging \& Rehabilitation" in Naples, FL. The side of the stroke, the type of the stroke, or a history of prior stroke are not considerations. The study is intended to be very clinically focused to better understand the activity level of the population seen at the facility. This study is purposely not controlling the population to a very narrow presentation so that the results will speak directly to the facility and their outcomes

Brief summary: Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be recruited into the study. The participants will wear two activity monitors (one commercial grade and one research grade) for the duration of their rehab stay. Data from the monitors will be correlated with rehab outcomes, therapy units billed, and length of stay.


Eligibility criteria: Inclusion Criteria:

* diagnosis of stroke
* patient at the Brookdale Center for Healthy Aging \& Rehabilitation
* not greater than maximum assistance to walk 10 feet
* walking re-training included in the therapy plan of care

Exclusion Criteria:

* primary diagnosis other than stroke
* allergy or reaction to the wrist bands of the activity monitors

Primary outcomes:
measure: Physical Activity Level
timeFrame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Secondary outcomes:
measure: therapy units billed
timeFrame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
measure: Functional Independence Measure (FIM)
timeFrame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Gulf Coast University
state: Florida
city: Naples
country: United States
facility: Brookdale Center for Healthy Aging & Rehabilitation
state: Florida
Study officials:
affiliation: Florida Gulf Coast University
name: Mollie Venglar, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04558411: Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students
Official title: Pilot Study of a Brief, Scaleable Intervention for COVID-19 Mental Health Sequelae in College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Affect
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. Participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. Both groups will be assessed weekly throughout the Fall semester to monitor the transition to the new semester and longer-term impact of the intervention. The control condition participants will have access to the skills videos at the end of the study.


Eligibility criteria: Inclusion Criteria

* Age 18 years or older
* Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
* Currently residing in the United States
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* iOS and Android smartphone compatible with MetricWire

Exclusion Criteria

* Non-English speaking
* Unable to understand or provide informed consent

Primary outcomes:
measure: Distress
timeFrame: Six week daily monitoring period
measure: Emotion regulation
timeFrame: Six week daily monitoring period
measure: Distress (within-person change)
timeFrame: Six week daily monitoring period
Secondary outcomes:
measure: Maintenance of improvement in emotion regulation
timeFrame: Six week post-daily monitoring period
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT02065011: A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
Official title: An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Usher's Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 9
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: Primary Objective:

To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B

Secondary Objective:

To assess long-term safety and biological activity of SAR421869

Detailed description: The total duration of study period is up to 15 years.

Eligibility criteria: Inclusion criteria :

Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA).

Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of SAR421869

Exclusion criteria:

Did not receive SAR421869 as part of the TDU13600 protocol.

Primary outcomes:
measure: The incidence of adverse events
timeFrame: 15 years
Secondary outcomes:
measure: Clinically important changes in ocular safety assessments
timeFrame: baseline to 15 years
measure: Delay in retinal degeneration
timeFrame: baseline to 15 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University Site Number : 840001
state: Oregon
city: Paris
country: France
facility: Investigational Site Number : 250001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00497211: Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Keywords: First large acute myocardial infarction
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2007-07-06
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥20 and \<80 years old
* Acute myocardial infarction \>2 and \<96 hours from start to reperfusion
* Cumulative ST-segment elevation \>6 mm on 12 lead ECG
* No functional myocardial impairment outside the myocardial infarction region
* Succesful PCI of infarct related coronary artery
* Left ventricular ejection fraction \<50% on ventriculography, echo or MRI
* Accepted anticonceptive use during the study for women of childbearing potential
* Written and signed informed consent

Exclusion Criteria:

* CPR \> 10 minuts or persistent cardiogenic shock
* complete left bundle branch block without concordant ST-segment elevation
* Need foor cardiac surgery (valvular, coronary or other)
* Trombocytopenia, coagulation disorders or hematological disease
* History or active malignancy
* Life expectancy (apart from acute myocardial infarction) \<5 years
* Dialysis or severe kidney insufficiency (creatinin clearance \<30ml/')
* Severe liver insufficiency
* Severe respiratory disease
* Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
* Symptomatic cerebral or periferal vascular disease
* Prior myocardial infarction or prior myocardial dysfunction
* Prior CABG or heart valve surgery
* Pregnancy, pregnancy wish or lactation \<1 month
* Psychiatrical illness
* Physical or psychological inability to adhere to the protocol
* Participation in other not yet completed study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
Study officials:
affiliation: UZ Antwerpen
name: Steven E Haine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Antwerpen
name: Chris Vrints, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06544811: American Indian Smokefree Native RCT
Official title: Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2024-08-09
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* AI race based on self-report;
* ≥ 18 years of age via photo ID confirmation;
* Average smoked cigarettes per day, ≥ 3 in the past 30 days;
* considering or willing to make a quit attempt;
* self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
* able to read and speak English.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
timeFrame: 6 months
Secondary outcomes:
measure: Percent of participants that are biochemically-confirmed 7-day abstinence
timeFrame: 1 and 3 months
measure: Percent of participants that self-report 24-hour abstinence
timeFrame: 1, 3, and 6 months
measure: Percent of participants that self-report 7-day abstinence
timeFrame: 1, 3, and 6 months
measure: Percent of participants that self-report 30-day abstinence
timeFrame: 3 and 6 months
measure: Mean cigarettes per day in past 7 days
timeFrame: 1, 3, and 6 months
measure: Number of 24-hour quit attempts in past 30 days
timeFrame: 1, 3, and 6 months
measure: Percent of participants that used nicotine replacement therapy and pharmacotherapy
timeFrame: 1, 3, and 6 months
measure: Percent of participants that used other behavioral support
timeFrame: 1, 3, and 6 months
measure: Percent of participants that used other commercial tobacco products
timeFrame: 1, 3, and 6 months
measure: Mean cigarette dependence
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
Study officials:
References:
Clinical trial NCT00449111: An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)
Official title: An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.


Eligibility criteria: Inclusion Criteria:

* Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1
* Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1

Exclusion Criteria:

* History of angina pectoris that has not been stabilized in the past 6 weeks
* History of clinically significant abnormal lab results or diseases
* Myocardial infarction within the past 6 months
* Stroke in the past 6 months

Primary outcomes:
measure: Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: