louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01539577: A Long-Term Safety Study of OZURDEX® in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Macular Edema
Uveitis, Posterior
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 875
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 macular oedema due to CRVO or BRVO or non-infectious uveitis

Brief summary: This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.


Eligibility criteria: Inclusion Criteria:

* Macular oedema following either BRVO or CRVO or non-infectious uveitis
* Requires treatment with OZURDEX®

Exclusion Criteria:

* Current participation in any clinical study

Primary outcomes:
measure: Incidence of Patients Reporting Serious Adverse Events
timeFrame: 2 years
measure: Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
city: Ulm
country: Germany
city: Barcelona
country: Spain
city: Bradford
country: United Kingdom
state: West Yorks
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02142777: S-Equol in Alzheimer's Disease (SEAD) Trial
Official title: S-Equol in Alzheimer's Disease (SEAD) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: S-equol
COX activity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Ausio Pharmaceuticals, LLC
First posted: 2014-05-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).

Detailed description: Alzheimer's disease (AD) is a progressive brain disorder which causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produces energy) might be linked to symptoms of AD. Some studies have shown that patients with Alzheimer's disease have reduced mitochondrial activity or have fewer mitochondria present in neurons. In this study, it is believed that by targeting mitochondria, we might learn more about its influence on AD symptoms.

Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor β (ERβ). When estrogen attaches to this site, it promotes mitochondrial function. Studies have also suggested ERβ stimulation can cause cells to create new mitochondria. More mitochondria, or increased activity of existing mitochondria, in the cell might have an impact on patients with Alzheimer's disease. One way to measure this increase in function is to look for the presence of an enzyme called COX in your blood. If a drug increases mitochondrial function, there will be an increase in COX concentration in the bloodstream.

By doing this study we hope to learn if S-equol, a compound that acts like estrogen in the body, causes such an increase in mitochondrial activity. We also hope to determine the tolerability of a therapeutic dose of S-equol. It is our goal to advance the understanding of AD, particularly in women.

Eligibility criteria: Inclusion Criteria:

* Very mild (CDR 0.5) or mild (CDR 1) AD at time of last KU ADC assessment
* Have a study partner
* Speak English as primary language

Exclusion Criteria:

* No viable study partner
* Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
* Use any type of estrogen replacement therapy

Primary outcomes:
measure: platelet mitochondria cytochrome oxidase (COX) activity
timeFrame: Change from Baseline to 6 Weeks
Secondary outcomes:
measure: safety of S-equol
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Russell H Swerdlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02375477: Improved Adherence to C. Difficile Isolation Protocols Through Improved Education Methods
Official title: Improved Adherence to C. Difficile Isolation Protocols Though Improved Inter-disciplinary Educational Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infection
Clostridium Difficile
Keywords: Clostridium difficile
C. difficile
adherence
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-02
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial studies how well inter-disciplinary educational methods work in improving adherence to isolation protocols in patients with Clostridium (C.) difficile infections. An inter-disciplinary educational method may help to prevent the spread of infection.

Detailed description: PRIMARY OBJECTIVES:

I. To lower rates of C. difficile transmission through improved adherence to recommended isolation protocols.

SECONDARY OBJECTIVES:

I. Improve resident knowledge of infection control procedures and engagement in quality improvement initiatives.

OUTLINE:

Residents and nurses are given a short presentation on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.

After completion of study, residents and nurses complete post-tests to determine the effectiveness of the training every 6 months.

Eligibility criteria: Patient Criteria

Inclusion Criteria:

* Patient on the gynecologic oncology service
* Admitted to Seidman 6th floor of the Seidman Cancer Center
* Diarrhea or clinical concern for C. difficile infection

Exclusion Criteria:

* None

Medical Staff Criteria:

Inclusion Criteria:

* Any resident or nurse treating a patient meeting the above criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of C. difficile infection
timeFrame: Up to 1 year
Secondary outcomes:
measure: Proportion of patients with an isolation order placed concurrently with the order for C. difficile
timeFrame: Up to 1 year
measure: Difference in scores post-test minus pre-test
timeFrame: Baseline to up to 1 year
measure: Retention of information
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: John Nakayama
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903677: The Relationship Between Preoperative Levels of Ionized Magnesium and Risk of Acute Kidney Injury After Cardiac Surgery
Official title: The Relationship Between Preoperative Levels of Ionized Magnesium and Risk of Acute Kidney Injury After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Magnesium Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people more than or equal 18 years who undergo open heart surgery between July 2023 to July 2024 and not known to have kidney disease .

Brief summary: Detection the relationship between preoperative ionized magnesium levels and the risk of acute kidney injury after cardiac surgery.

Detailed description: Acute kidney injury (AKI) is a major medical problem that is of particular concern after cardiac surgery. The reported prevalence of cardiac surgery-associated acute kidney injury (CSA-AKI) is up to 30% and is independently associated with an increase of morbidity and mortality .So this study is for measuring preoperative ionized magnesium levels of patients who will undergo cardiac surgeries then measuring postoperative serum creatinine, BUN and urine output to detect if they developed AKI or not and if there is a relationship between the post cardiac surgery AKI and preoperative ionized magnesium levels.

Eligibility criteria: Inclusion Criteria:

1. patients more than or equal 18 yrs.
2. patients undergoing cardiac surgery between July 2023 and July 2024

Exclusion Criteria:

1. patients with known Kidney disease.
2. patients less than 18 yrs

Primary outcomes:
measure: Post cardiac surgery AKI according to KDIGO criteria with low preoperative magnesium level
timeFrame: Baseline
measure: Post cardiac surgery AKI according to KDIGO criteria with normal or high preoperative magnesium level
timeFrame: basline
measure: Post cardiac surgery normal kidney functions with low preoperative magnesium level
timeFrame: basline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Koh HB, Jung CY, Kim HW, Kwon JY, Kim NH, Kim HJ, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. Preoperative Ionized Magnesium Levels and Risk of Acute Kidney Injury After Cardiac Surgery. Am J Kidney Dis. 2022 Nov;80(5):629-637.e1. doi: 10.1053/j.ajkd.2022.03.004. Epub 2022 Apr 23.
Clinical trial NCT03577977: Betaferon Use in Children and Adolescents With Multiple Sclerosis
Official title: Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis (MS), Betaseron, Betaferon
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-07-05
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.

Brief summary: The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents


Eligibility criteria: Inclusion Criteria:

* patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
* patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
* recorded use of at least one dose of Betaferon before January 1, 2008

Exclusion Criteria:

* Diagnosis other then MS or a demyelinating CNS disease

Primary outcomes:
measure: Mean expanded disability status scale (EDSS) score at the end of trial participation
timeFrame: Up to 2 years
measure: Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial
timeFrame: Up to 2 years
measure: Mean frequency of complications recorded after start of betaferon therapy
timeFrame: Up to 2 years
measure: Mean EDSS score on the exacerbations recorded after start of betaferon therapy
timeFrame: Up to 2 years
measure: Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug
timeFrame: Up to 2 years
measure: Number of mild, moderate, or severe adverse events
timeFrame: Up to 2 years
measure: Number of serious adverse events described during the trial
timeFrame: Up to 2 years
measure: Number of adverse events described during the trial and classified as an flu-like syndrome
timeFrame: Up to 2 years
measure: Number of adverse events described during the trial and classified as a local reaction
timeFrame: Up to 2 years
measure: Number of cases of betaferon discontinuation due to adverse events
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00998777: Shoulder Injury Prevention Program in Swimmers
Official title: The Effect of a 6-week Shoulder Strengthening Program on Scapular Kinematics and Shoulder Strength in Division I Collegiate Swimmers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Injury
Keywords: tubing program
shoulder strengthening
injury prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder strengthening and stretching program in division I collegiate swimmers. The result of this study may demonstrate the effectiveness of a strengthening and stretching program to positively influence factors that have been associated with pain and injury in division I collegiate swimmers and indicate the need to implement this program for the entire team. Following a 6-week strengthening and stretching program, it is believed that scapular kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be improved compared to control subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects will be included in the study if they meet the following criteria:

  * NCAA division I swimmers
  * Participate in swimming for at least 30 minutes per day for 4 days per week.
  * Participate in all team weight lifting sessions.
  * Complete 15 of the 18 training sessions if the subject is placed in the treatment group.

Exclusion Criteria:

* Subjects will be excluded from the study if:

  * They are currently being treated for shoulder pain
  * They develop shoulder pain during the course of the intervention program

Primary outcomes:
measure: Shoulder and Scapular Stabilizer Strength
timeFrame: Measured pre and post test
Secondary outcomes:
measure: Scapular Kinematics
timeFrame: Measured pre and post test
measure: Shoulder ROM
timeFrame: Measured pre and post test
measure: Postural Assessment
timeFrame: Measured pre and post test
measure: Width of subacromial space
timeFrame: Measured pre and post test
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Dean E. Smith Center
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Elizabeth Hibberd
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC- Chapel Hill
name: Joseph B Myers, PhD, ATC
role: STUDY_DIRECTOR
References:
Clinical trial NCT04074577: Computer Aided Detection, Tandem Colonoscopy Study
Official title: Computer Aided Detection, Tandem Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 32
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy
* Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation

Exclusion Criteria:

* People with diminished cognitive capacity
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients referred for endoscopic mucosal resection (EMR)

Primary outcomes:
measure: Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Seth Gross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190877: Monitoring Subjects With Fluid-Management Issues In the Home Environment
Official title: A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Hypertension
Keywords: Heart Failure
Impedance
Fluids
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or more diuretic medication(s) prescribed by a physician

Brief summary: This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.

Detailed description: The study has the following objectives:

Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational

Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation

Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device

Eligibility criteria: Inclusion Criteria:

* Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
* Subject will have a current prescription for a diuretic medication.
* Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

* Subject is participating in another clinical study that may affect the results of either study.
* Subject is unable or not willing to wear electrode patches as required.
* Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
* Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
* Subject is considered by the PI to be medically unsuitable for study participation.

Primary outcomes:
measure: Ease of Use
timeFrame: Each subject will be measured once per weekday over a 6 week period
Secondary outcomes:
measure: SKin irritation and reproducibility
timeFrame: Each subject will be measured once per weekday over a 6 week period
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Riverside Meadows
state: California
Study officials:
affiliation: Baxter Healthcare Corporation
name: Matthew Banet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005287: Late Sequelae of Bronchopulmonary Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Bronchopulmonary Dysplasia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To measure the cardiopulmonary function in individuals who developed bronchopulmonary dysplasia (BPD) at Stanford University Medical Center from 1964-1973 and to determine the factors associated with the presence of cardiopulmonary function abnormalities in these adolescents and young adults.

Detailed description: BACKGROUND:

Eleven to 22 percent of prematurely born human infants with Respiratory Distress Syndrome (RDS) treated with artificial ventilation and supplemental oxygen therapy, develop a severe chronic lung disease called bronchopulmonary dysplasia. While many children who had BPD are asymptomatic by three years of age, some can have respiratory symptoms and abnormal pulmonary function tests at nine years of age. The hypothesis tested in this study is that abnormalities of pulmonary function seen in infants with BPD can persist into adolescence, even in asymptomatic children and young adults.

DESIGN NARRATIVE:

A detailed interval pulmonary history was taken. Pulmonary abnormalities were determined by pulmonary angiography and lateral chest x-ray and pulmonary function tests for small airway obstruction, reversible bronchial hyperreactivity, distribution of ventilation, air trapping and hyperinflation, residual interstitial disease or edema, vascular bed loss, and gas exchange. Right and left ventricular hypertrophy were evaluated by electrocardiogram. Elevated right ventricular pressure was estimated by echocardiography with doppler ultrasound. The atopic status of the children was determined. Other abnormalities, including growth retardation, developmental delay, hearing loss, retrolental fibroplasia, and neurologic disability seen in BPD were assessed by history and physical examination.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Northway WH Jr, Moss RB, Carlisle KB, Parker BR, Popp RL, Pitlick PT, Eichler I, Lamm RL, Brown BW Jr. Late pulmonary sequelae of bronchopulmonary dysplasia. N Engl J Med. 1990 Dec 27;323(26):1793-9. doi: 10.1056/NEJM199012273232603.