louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00354471: Uterine Artery Embolization for Symptomatic Fibroids
Official title: Short and Long Term Outcomes of Uterine Artery Embolization.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroids
Menorrhagia
Adenomyosis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2006-07-20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Time perspective: PROSPECTIVE

Brief summary: This study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. It will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.


Eligibility criteria: Inclusion Criteria:

* Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options
* Confirmation of fibroids by endovaginal and transabdominal ultrasound

Exclusion Criteria:

* Pedunculated fibroids
* Desire for fertility
* Carcinoma of pelvic organs
* Previous pelvic irradiation
* Bleeding diathesis and vasculitis
* History of allergiy to contrst medium

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Richard S Boroditsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739371: Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)
Official title: Food Intake and Intra-Nasal Insulin for African American Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin
Keywords: Intranasal Insulin
Food Intake
APOE
Cognition
African American
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Nutrition Obesity Research Center
First posted: 2021-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this research study is to investigate brain insulin's relationship with food intake in African Americans. Facilitating insulin's entrance into the brain through a nasal spray is currently being studied as a way to prevent or treat Alzheimer's disease. However, brain insulin may also have an impact on food intake. This study is designed to help researchers understand how different factors related to Alzheimer's disease (i.e. APOE genotype and cognitive functioning) influence brain insulin's relationship with food intake.

Detailed description: The investigators will utilize a double-blind, placebo-controlled, randomized crossover design comparing a single acute dose of intranasal insulin to a single acute dose of a saline placebo.

The primary aim will consist of exploring the differences in ingestive behaviors constructs (i.e. hunger, satiety, and fullness) and ad libitum lunch caloric intake between acute administration of either a dose of intranasal insulin or saline placebo. The hypothesis is that acute intranasal insulin will result in the consumption of fewer calories, greater feelings of satiety and fullness, and less hunger compared to acute saline. A secondary aim of this investigation will be to analyzing differences in food intake by APOE genotype, adiposity, and AD family history.

Eligibility criteria: Inclusion Criteria:

* self-identify as African American
* are aged 45 years to 65 years old
* are willing to provide written informed consent
* speak and read English

Exclusion Criteria:

* diagnosed with type 1 or 2 diabetes
* pregnant or attempting to become pregnant
* have a history of sensitivity to glutaraldehyde

Primary outcomes:
measure: Change in caloric intake
timeFrame: 30 minutes post intranasal insulin administration
measure: Change in ingestive behavior constructs
timeFrame: 30 minutes post intranasal insulin administration
Secondary outcomes:
measure: Number of participants who are APOE e4 carriers versus noncarriers
timeFrame: Through study completion, an average of 1 year
measure: Characterize AD family history (via a questionnaire)
timeFrame: Day 1
measure: Amount of adiposity (i.e. DXA) per participant
timeFrame: Day 4
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Owen T Carmichael, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01494571: Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
Official title: Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functionality and Performance of Device
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 101
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 400 children, aged 2 months to 14 years

Brief summary: The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.

Detailed description: Up to 400 children, ages 2 months through 14 years

1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
2. To document completeness of injections; completeness is defined as \<10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
3. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.

Eligibility criteria: Inclusion Criteria:

* Infants and children between ages 2 months and 14 years
* Outpatient, expected to go home day of surgery
* Written consent and assent when appropriate
* Willing to complete and return pain diary (postcard) after 48 hours

Exclusion Criteria:

* Presently have skin rash at the intended injection site
* Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
* Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
* Skin disorders that may predispose them to develop skin lesions at sites of trauma.
* Present use of any blood thinning medications.
* In the 10-11 year old cohort, none of the participants can have started puberty.

Primary outcomes:
measure: Completeness of injection
timeFrame: within one minute after injection
measure: Size of bleb on skin after injection
timeFrame: within 2 minutes after injection
measure: Acceptability by subject
timeFrame: up to 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jeffrey Galinkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570971: Mannitol Versus Supportive Care in Ciguatera Fish Poisoning
Official title: Mannitol Versus Supportive Care in Ciguatera Fish Poisoning: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ciguatoxin
Keywords: mannitol
treatment
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Florida Poison Control Center
First posted: 2015-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.


Eligibility criteria: Inclusion Criteria:

* History consistent with ciguatera poisoning

Exclusion Criteria:

* Minors
* pregnant patients
* those unable to give consent
* severe congestive heart failure or renal failure

Primary outcomes:
measure: Symptom score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06382571: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients
Official title: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult out - patients who were first diagnosed be heart failure with left vetricular ejection fraction less than 40% and recieved one of ACEIs,ARBs,ARNI drugs.

Brief summary: Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).

Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group.


Eligibility criteria: Inclusion Criteria:

* Patients who were first diagnosed be heart failure with left ventricular ejection fraction less than 40%.
* Received one of ACEIs,ARBs,ARNI drugs.

Exclusion Criteria:

* Electronic medical records was not complete enough to analyse.
* Patients who had history of heart transplantation or had heart transplantation plan in last 12 months.

Primary outcomes:
measure: factors associated with sub - target dose of ACEIs,ARBs,ARNI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00139971: Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: West Japan Thoracic Oncology Group
Sponsor class: OTHER
First posted: 2005-08-31
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. completely resected non small cell lung cancer
2. no prior anti cancer treatment for thoracic malignancy exept for this operation
3. pathological stage IB, II, and stage IIIA with only one station of n2 disease
4. PS 0-1
5. age 20-75
6. adequate organ function for chemotherapy
7. written informed consent

Exclusion Criteria:

1. small cell lung cancer or low grade malignancy of lung cancer
2. incomplete resection
3. apparent interstitial pneumonitis at chest rentogenogram
4. inadequate condition for chemotherapy

Primary outcomes:
measure: 5 year survival rate
Secondary outcomes:
measure: Disease free survival
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka City General Hospital
Study officials:
affiliation: West Japan Thoracic Oncology Group
name: Hirohito Tada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06845371: MELODY Registry Follow-Up Study
Official title: MELODY Registry Follow-Up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Heart Disease (CHD)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 845
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent Melody valve implantation into the pulmonary position after its commercialization in Europe / OUS

Brief summary: Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS


Eligibility criteria: Inclusion Criteria:

* previous inclusion in the MELODY Registry

Exclusion Criteria:

* none

Primary outcomes:
measure: primary outcome
timeFrame: from december 2006 up to December 2027
Secondary outcomes:
measure: secondary measure
timeFrame: from december 2006 up to December 2027
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06678971: Effects of a Basketball-Specific Warm-Up, "Basket Up," on the Sports Performance of Young Basketball Players
Official title: Effects of the 9-Week Warm-up Program, Basket Up, on Sports Performance in Young Basketball Athletes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jumping Performance
Speed
Agility
Keywords: Sports Performance
Speed
Agility
Jumping Performance
FIFA 11+
Warm-up
Basketball
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2024-11-07
Enrollment: 65
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a specific 9-week basketball warm-up program, "BasketUp," on athletic performance, comparing it to the FIFA 11+ program. Male and female basketball players are randomly assigned to either the BasketUp or FIFA 11+ warm-up groups, performing these routines before practice three times a week for 9 weeks. Key performance metrics-sprinting speed, countermovement jump (CMJ), and agility-are measured at the start and end of the study.

Detailed description: Current evidence is limited on the effectiveness of basketball-specific warm-up programs. This study evaluates the impact of a 9-week basketball-specific warm-up, "BasketUp," on sports performance, comparing it with the FIFA 11+ program. Male and female basketball athletes, are randomly assigned to either the BasketUp program or FIFA 11+. Both warm-ups are performed three times per week before basketball practice over the 9-week period. Performance measures-including sprinting, countermovement jump (CMJ), and agility-are assessed at the beginning and end of the intervention. A two-way mixed ANOVA analyzes the effect of time (baseline vs. 9 weeks) and group on these outcomes.

Eligibility criteria: Inclusion Criteria:

* Have competed in at least one national basketball event within the past two years
* Consistently attend basketball practices throughout the season

Exclusion Criteria:

* Any current injury or condition restricting athletic activity
* A history of injury necessitating non-surgical treatment within the past 3 months
* A history of injury requiring surgery within the last 9 months

Primary outcomes:
measure: Agility
timeFrame: At baseline and after 9 weeks
measure: Vertical jump-related outcomes
timeFrame: At baseline and after 9 weeks
measure: Velocity
timeFrame: At baseline and after 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alfara del Patriarca
country: Spain
facility: UCH CEU Univesity
state: Valencia
Study officials:
References:
Clinical trial NCT02060071: Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity
Official title: Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Stenosis
Cardiac Death
Keywords: aortic stenosis
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

Detailed description: Degenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and increases in prevalence with age. Severe aortic valve stenosis accounts for considerable disease and death, especially in older patients. Aortic valve stenosis is the primary indication for valve replacement in western countries, and the number will only increase as elderly people are a growing subpopulation. Measures to identify AV disease earlier, to identify factors that influence disease progression and treat AV disease pharmacologically or with less invasive approaches would be a significant improvement over the current standard of care. These advances will only be possible with a better understanding the mechanisms underlying valve development and disease. Preliminary data suggest a novel pathophysiological concept for impaired valvular endothelial cells regeneration, leading to the progression of age-associated calcific AV disease and a potential treatment target is the disrupted endothelial cell layer of the valve leaflet.

The research objectives are:

1. To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
2. To study the association between aortic stenosis progression, severity, symptoms and left ventricular function and the number and function of circulating endothelia progenitor cells. By understanding the correlation between valve severity, left ventricular longitudinal function and endothelial progenitor cells we will indentify high risk patients population that need early intervention. We hope to add new information on the pathogenesis of aortic stenosis and to indentify factors that predict disease progression.

Eligibility criteria: Inclusion Criteria:

* Patients with Aortic stenosis
* Control with aortic stenosis

Exclusion Criteria:

* No

Primary outcomes:
measure: Cardiac death or need for intervantion in correlation to endothelial progenitor cells
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical
name: Sara Shimoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03469271: Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Official title: Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Keywords: Pneumonia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Andersen Foundation
First posted: 2018-03-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer
* Renal and hepatic function (creatinine \</= 2 x the institutional upper limit of normal; bilirubin \</= 2 x the institutional upper limit of normal)
* No contraindication to receive either of the planned interventions of inspiratory resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider
* No difficulties with swallowing oral medications in the opinion of the enrolling physician

Exclusion Criteria:

* Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
* Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports unable to walk one block without difficulty)
* Calcium or phosphorus level above the institutional upper limit of normal

Primary outcomes:
measure: Sniff Nasal Inspiratory Pressure (SNIP)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04517071: Predictors of Success Following Bariatric Surgery
Official title: Predictors of Success Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study is Patient Responses to an Obesity Management Questionnaire Administered by SGH Life Centre
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singaporeans who have undergone bariatric surgery

Brief summary: This study aims to consolidate the contributions of various medical, social and psychological predictors of success following bariatric surgery amongst Singaporeans.


Eligibility criteria: Inclusion Criteria:

* Undergone bariatric surgery within SGH lIfe centre and must have completed the intake questionnaire.

Exclusion Criteria:

-

Primary outcomes:
measure: Weight Loss
timeFrame: Immediately post-surgery within first year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References: