louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04103008: Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography
Official title: Effect of Residual Myocardial Ischemia on Recovery of Left Ventricular Function After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Echocardiography 2D
Left Ventricular Dysfunction
Keywords: Speckle tracking
2D echocardiography
Left ventricle residual function
PCI, percutaneous coronary intervention
single coronary artery
multiple coronary arteries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction with single or multiple coronary artery lesions seen after PCI on admission and after 40 days

Brief summary: Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. However, this technique has limitation related with its intra- and interobserver variability. A recent technique, 2D speckle tracking for assessing global longitudinal strain, has been introduced to reduce the variability and potentially has a higher accuracy. Speckle tracking is a method which uses two dimensions recording for measuring quantity of movement of myocardium in several segments.

Speckle-tracking echocardiography is a current noninvasive ultrasound imaging technique that allows for an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and from cardiac translational movements,

Detailed description: Authors using 2D speckle tracking found that subclinical LV systolic dysfunction is common in patients with isolated severe mitral stenosis (MS) and is determined primarily by the hemodynamic variables of MS severity and reduced LV filling. BMV results in rapid recovery of LV systolic function in these patients through improvement in LV diastolic loading. These findings suggest that LV contractile properties in MS are modulated predominantly by LV diastolic filling rather than myocardial structural abnormality.

Eligibility criteria: Inclusion Criteria:

* Patients with acute myocardial infarction eligible for PCI seen on admission and after 40 days

Exclusion Criteria:

* cardiomyopathy
* cancer
* on cytostatic treatment.

Primary outcomes:
measure: Assessing change of left ventricular function
timeFrame: baseline and after 40 days of PCI
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 40 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Professor of Cardiology
name: Amr A Youssef, MD
role: STUDY_CHAIR
affiliation: Associate Professor
name: Mohamed A Abdel Hafez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03177408: Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients
Official title: Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastolic Dysfunction
Hypertension
Inflammation
Keywords: Diastolic Dysfunction
Hypertension
HMGB1
Lead sponsor: Affiliated Hospital of Hebei University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study sample is recruited from the patients examined in the physical examination center of our hospital.

Brief summary: This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic.


Eligibility criteria: Inclusion Criteria:

All of the hypertensive patients in both diastolic dysfunction and control groups were either newly diagnosed or were aware of hypertension without using any pharmacotherapy.

-

Exclusion Criteria:

Individuals already under treatment for hypertension were not include.

-

Primary outcomes:
measure: Differences of HMGB1 levels between hypertensive patients with and without diastolic dysfunction
timeFrame: on the day of admission
Secondary outcomes:
measure: Differences of HMGB1 levels between grades of diastolic dysfunction
timeFrame: on the day of admission
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00713908: Voiding Dysfunction in the Postoperative Period Following Placement of the TVT
Official title: Voiding Dysfunction in the Postoperative Period Following Placement of the TVT
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Voiding Dysfunction
Keywords: Voiding dysfunction following TVT placement
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: The purpose of this study is to evaluate how often women have problems passing their urine (voiding) after TVT (Tension Free Vaginal Tape) surgery. This will help us to better understand normal voiding function after surgery as well as to find factors that may help us predict who will have problems after surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stress incontinence, diagnosis must be confirmed by cough stress test or multichannel urodynamics
* Undergoing minimally invasive sling procedure - TVT (by transvaginal or surpapubic approach)
* Must be competent to give informed consent

Exclusion Criteria:

* No diagnosis of stress urinary incontinence
* Undergoing minimally invasive sling procedure by route other than TVT
* Undergoing any other pelvic organ prolapse repair procedures
* Pregnancy
* Known voiding dysfunction preoperatively

Primary outcomes:
measure: Post-void residual volume
timeFrame: Pre-operative and post-operative periods
Secondary outcomes:
measure: 2-day voiding diary, uroflow, standardized questionnaires
timeFrame: Pre-operatively and post-operatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michael K. Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662608: Compassionate Use of Brontictuzumab for Adenoid Cystic Carcinoma (ACC)
Official title: NOTCH 1 Inhibitor Brontictuzumab for Adenoid Cystic Carcinoma Bearing Two Activating NOTCH1 Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoid Cystic Carcinoma
Keywords: Brontictuzumab
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.

Detailed description: Treatment:

Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.

Clinic Visits:

On Day 1 of Cycle 1 and then every 3 weeks from then on:

* Participant will have a physical exam
* Blood (about 3 teaspoons) will be drawn for routine tests.

Every 6 weeks, participant will have an MRI and CT scan to check the status of the disease.

Length of Treatment:

Participant may continue taking brontictuzumab for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the drug if the disease gets worse, they develop another illness that prevents receiving more treatment, or if intolerable side effects occur.

Brontictuzumab is not FDA approved or commercially available. It is currently being used for research purposes only.

Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
2. Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1000/mm3, platelets ≥50,000/dL, hemoglobin ≥8 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal.
3. Central Nervous System (CNS) metastases allowed if subject does not require steroids, brain metastases are clinically stable without symptomatic progression
4. Capability to understand and comply with the protocol and signed informed consent document.

Exclusion Criteria:

1. Major medical conditions that might affect study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
2. Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator.

Primary outcomes:
measure: Number of Participants With Disease Progression
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Renata Ferrarotto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03518008: Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Official title: Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Errors
Keywords: soft contact lenses
vision
eyesight
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.


Eligibility criteria: Inclusion Criteria:

* Understand and sign an Informed Consent Form;
* Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Refractive, ocular, or intraocular surgery, as specified in the protocol;
* Eye condition or injury, as specified in the protocol;
* Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
* Currently wearing clariti® 1 day contact lenses;
* Habitually wearing monovision or multifocal lenses during the last 3 months;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Overall Quality of Vision
timeFrame: Day 8, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT05712408: Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Official title: Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).


Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* a self-reported diagnosis of multiple sclerosis
* relapse free in past 30 days
* non-pregnant
* willing and able to visit University of North Texas on two testing occasions

Exclusion Criteria:

* electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)

Primary outcomes:
measure: Metabolic Health
timeFrame: From recruitment to end of 8 week intervention
measure: Body Weight
timeFrame: From recruitment to end of 8 week intervention
measure: Body Fat
timeFrame: From recruitment to end of 8 week intervention
Secondary outcomes:
measure: 6-Minute Walk
timeFrame: From recruitment to end of 8 week intervention
measure: 25-Foot Walk
timeFrame: From recruitment to end of 8 week intervention
measure: Cognitive Assessments
timeFrame: From recruitment to end of 8 week intervention
measure: Fatigue
timeFrame: From recruitment to end of 8 week intervention
measure: Health-Related Quality of Life
timeFrame: From recruitment to end of 8 week intervention
Other outcomes:
measure: Acceptability of Intervention
timeFrame: From recruitment to end of 8 week intervention
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Stephanie Silveira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547508: To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
Official title: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study in Men With Erectile Dysfunction to Evaluate the Efficacy and Safety of Tadalafil When Sexual Attempts Occur at Specific Time Points After Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 485
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.


Eligibility criteria: Inclusion Criteria:

* At least 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges

Primary outcomes:
measure: Prove superiority to placebo by measuring question 3 of the SEP diary
timeFrame: 6-10 and 24 weeks
Secondary outcomes:
measure: Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary
timeFrame: 6-10 and 24 weeks
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03430908: Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography
Official title: Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: endotracheal tube
gastric tube
17-653
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider.

Brief summary: This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.


Eligibility criteria: Inclusion Criteria:

* The adult population, ages 18 and greater
* Patients undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider

Exclusion Criteria:

* Pediatric population (\<18 years)
* Gastric tube inserted under direct visualizing (the use of a Mac or Miller laryngoscope or any video laryngoscope)
* Inability to visualize gastric tube by ultrasound due to body habitus, analogous anatomy, etc
* Pre-anesthesia insitu gastric tube
* Gastric tube inserted by practitioner other than a member of the anesthesia team

Primary outcomes:
measure: Incidence of malposition of blindly placed gastric tubes by anesthesia providers
timeFrame: Day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Luis E Tollinche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519008: Effectiveness and Security Testing of a Mobile App
Official title: Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness and security of a mobile App (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit/hyperactivity disorder comparing 40 patients with treatment as usual (TAU) with 40 patients with TAU plus the mobile App


Eligibility criteria: Inclusion Criteria:

* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of attention-deficit/hyperactivity disorder
* High emotion dysregulation severity
* Aged 14 to 17 years
* Outpatient setting (Consorci Sanitari del Maresme

Exclusion Criteria:

* Comorbidity with mental retardation
* Comorbidity with psychotic disorder
* Comorbidity with autism spectrum disorder

Primary outcomes:
measure: Emotion dysregulation severity
timeFrame: 9 months
measure: Smartphone addiction
timeFrame: 9.months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06627608: Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
Official title: Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Hepatitis B
Keywords: Cost-Effectiveness Analysis
HBV Cure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart, AND
2. Patients achieved HBV cure, i.e. HBsAg turned negative
3. Aged 18 years old or above.

Brief summary: A number of hepatitis B virus (HBV) cure regimens including antisense oligonucleotide (ASO) and small interfering RNA (siRNA) are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval. Patients most in need should be prioritised to receive HBV cure regimen to maximise its clinical benefits and speed up hepatitis elimination.

Detailed description: A territory-wide cohort study of all patients with chronic hepatitis B who have achieved functional cure of HBV. Real-world data will be used to estimate the risk of HCC, hepatic decompensation, and liver-related death for the subsequent simulation of HCC risk in particular populations of patients who achieved HBV cure. Literature search also be performed in parallel to cross-validate the estimates in untreated patients, and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature. An optional systematic review and meta-analysis may be performed the address these issues.

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart, AND
2. Patients achieved HBV cure, i.e. HBsAg turned negative
3. Aged 18 years old or above.

Exclusion Criteria:

1. Patients with missing age and gender
2. Serious medical illnesses or malignancy with life expectancy \&amp;lt;1 year
3. Age \&amp;lt; 18 years

Primary outcomes:
measure: Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death
timeFrame: 20 years
Secondary outcomes:
measure: Economic burden
timeFrame: 20 years
measure: Partial HBV cure
timeFrame: 20 years
measure: Establish the most desirable cost range
timeFrame: 20 years
measure: Healthcare resources saving
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
References: