louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05557162: Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis
Official title: Artificial Intelligence Enhanced ECG to Detect Cardiac Amyloidosis: Protocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Amyloidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 20143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to assess a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of cardiac amyloidosis (CA).

Detailed description: This pragmatic trial will be the first study to prospectively evaluate the use of the AI ECG dashboard along with an augmented report in everyday practice. The findings will also guide future implementation strategies and inform the translation of many of the current and future AI algorithms into the clinical setting. The participants are the providers. Basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. Patient health information will be collected on their patients using a HIPPA waiver. There will be no patient contact.

Eligibility criteria: Inclusion Criteria:

* Mayo Clinic cardiology or hematology providers who care for adult patients
* Mayo Clinic providers who consent to participate on this study

Exclusion Criteria:

- None

Primary outcomes:
measure: To determine if AI ECG algorithm and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosisProtocol for a Pragmatic Cluster Randomized Clinical Trial (PREDICT-AMY)
timeFrame: 1 year
Secondary outcomes:
measure: To determine if AI ECG and enhanced algorithms and education enable earlier diagnosis of cardiac amyloidosis intervention across different practice types (strata)
timeFrame: 1 year
measure: To assess provider satisfaction with the AI ECG intervention
timeFrame: 1 year
measure: To assess differential costs between the intervention arm and the standard of care arm
timeFrame: 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System - Eau Claire
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Angela Dispenzieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802562: Medical Assistance in Dying Requests in Pain Clinic
Official title: Medical Assistance in Dying (MAiD) Requests in the Chronic Pain Clinic Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Terminal Diseases
Terminal Care
Chronic Pain
Disability or Chronic Disease Leading to Disablement
Keywords: Terminal disease
Physical disability
Chronic pain
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic pain and disability, undergoing treatment in a pain clinic.

Brief summary: Terminally ill patients often suffer existentially. Terminally ill patients with existential pain may request medical aid in dying. The Canadian government legalized Medical Assistance in Dying (MAiD) for patients unforeseeable deaths. This prospective observational study examined chronic pain clinic patients' MAiD requests. The study assessed the patients' life quality and outcomes.

Detailed description: Adult patients diagnosed with terminal or severe intractable illnesses frequently endure existential distress. Consequently, patients with terminal illnesses who experience existential distress may contemplate or seek medical assistance in dying (MAiD). In March 2021, the Government of Canada implemented amendments to the Criminal Code to authorize Medical Assistance in Dying (MAiD) for individuals whose natural death is not reasonably foreseeable.

This prospective observational study evaluated requests made for MAiD by patients in the chronic pain clinic setting. The study assessed the quality of life and natural outcomes of the patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients with chronic pain and disability.

Exclusion Criteria:

* Patients without physical disability.

Primary outcomes:
measure: How many years the patient lived after initial consultation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD, FRCPC
role: STUDY_DIRECTOR
References:
citation: Bamgbade OA, Sonaike MT, Adineh-Mehr L, Bamgbade DO, Aloul ZS, Thanke CB, Thibela T, Gitonga GG, Yimam GT, Mwizero AG, Alawa FB, Kamati LO, Ralasi NP, Chansa M. Pain Management and Sociology Implications: The Sociomedical Problem of Pain Clinic Staff Harassment Caused by Chronic Pain Patients. Anesth Pain Med. 2024 May 5;14(2):e144263. doi: 10.5812/aapm-144263. eCollection 2024 Apr.
Clinical trial NCT01004562: Collecting Information From Patients Enrolled in the Breast Specialized Program of Research Excellence
Official title: The Breast Cancer Specialized Program of Research Excellence (SPORE): Core A-Administrative/Biostatistics Core
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-30
Enrollment: 1025
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients of any age

Brief summary: RATIONALE: Collecting and storing information from patients with cancer to study in the future may help doctors learn more about cancer.

PURPOSE: This study is collecting information from patients enrolled in the Breast Specialized Program of Research Excellence.

Detailed description: OBJECTIVES:

* Provide a database for administrative and biostatistical support for the Breast Specialized Program of Research Excellence.

OUTLINE: Data is collected from patients for future research studies.

PROJECTED ACCRUAL: A total of 535 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Administrative and biostatistical support for the Breast Specialized Program of Research Excellence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Yufeng Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06295562: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
Official title: Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obstructive Sleep Apnea of Adult
Keywords: compensation
upper airway
Taiwan
serotonin
noradrenaline
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) atomoxetine 80mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.


Eligibility criteria: Inclusion Criteria:

* apnea-hypopnea index ≥ 15 hr-¹

Exclusion Criteria:

* the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases
* current use of continuous positive airway pressure therapy
* use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study
* known allergy to the investigational medication
* current smoking
* heavy alcohol drinking (male \> 14 drinks and women \>7 drinks per week)
* pregnant or lactating
* periodic limb movement index ≤ 15hr-1
* the presence of sleep-related hypoventilation

Primary outcomes:
measure: Physiological parameter
timeFrame: Baseline and one week
Secondary outcomes:
measure: Endotypic traits
timeFrame: Baseline and one week
Other outcomes:
measure: Sleep quality
timeFrame: Baseline and one week
measure: Waking sleepiness
timeFrame: Baseline and one week
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT00234962: Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
Official title: Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infection
Keywords: HIV Infection
HAART
Lopinavir
Ritonavir
Treatment Experienced
Treatment Naive
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.


Eligibility criteria: Inclusion Criteria:

* Subject is documented HIV positive
* Subject is greater than or equal to 18 years of age.
* Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
* Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
* Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
* Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin \>8.0 g/dL; Absolute neutrophil count \>750 cells/mL; Platelet count \>20,000/mL; ALT or AST \<3 x Upper Limit of Normal (ULN); Creatinine \<1.5 x ULN; Triglycerides \<750 mg/dL.
* Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.

Exclusion Criteria:

-

Primary outcomes:
measure: Antiviral efficacy by HIV RNA
Secondary outcomes:
measure: Treatment related discontinuations, predictors of adherence
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information - Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
Clinical trial NCT06009562: Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
Official title: Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Fibroid
Pregnancy Related
Keywords: Uterine fibroids
Pregnancy
myomectomy
fetal outcomes
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with symptomatic uterine fibroids (UFs)

Brief summary: The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.


Eligibility criteria: Inclusion Criteria:

* The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
* Circulatory disorders, evidenced by necrosis of the UFs.
* Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).

Exclusion Criteria:

* Refusal of LPTM by the patient.
* Absence of urgent indication for LPTM during pregnancy.

Primary outcomes:
measure: continuation of pregnancy
timeFrame: 5 months
Secondary outcomes:
measure: Fetal outcome
timeFrame: 5 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)
Study officials:
affiliation: University of Palermo
name: Andrea Etrusco, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06718062: Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia
Official title: Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension,Essential
Hyperuricemia
Keywords: Hypertension
Hyperuricemia
Non-inferiority
Lead sponsor: Hansung University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 66
Sex: ALL
Minimum age (years): 37
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the non-inferiority of Aliskiren compared to Losartan in the treatment of hypertension combined with hyperuricemia. Hypertension and hyperuricemia often coexist and may exacerbate each other, increasing the risk of cardiovascular and renal complications. Both Aliskiren and Losartan are widely used for managing hypertension, but their effects on serum uric acid levels and renal function are not well understood in this patient population.

This study will involve 66 participants, randomly assigned to receive either Aliskiren (240 mg daily) or Losartan (100 mg daily) for a treatment period of 3 months. The primary outcome will be the change in serum uric acid levels before and after treatment. Secondary outcomes include changes in blood pressure, kidney function (measured by creatinine levels, eGFR), and adverse events.

The primary objective is to demonstrate that Aliskiren is non-inferior to Losartan in lowering serum uric acid levels. Additionally, the study will assess whether Aliskiren, while effectively managing blood pressure, has a lesser impact on kidney function compared to Losartan.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Hypertension
2. Diagnosed with Hyperuricemia
3. Serum uric acid levels between 420 μmol/L and 700 μmol/L
4. Age between 18 and 80 years
5. Able to provide informed consent
6. No history of gout
7. No serious comorbidities such as severe kidney, liver, or cardiovascular diseases

Exclusion Criteria:

1. Diagnosis of Gout
2. History of secondary hypertension
3. Severe organ dysfunction, including liver, kidney, or heart failure
4. History of malignant tumors
5. Severe cognitive disorders or mental illness
6. Pregnant or breastfeeding women
7. Allergy to study medications (Aliskiren or Losartan)
8. Participation in other clinical trials during the study period

Primary outcomes:
measure: Change in Serum Uric Acid Levels
timeFrame: Baseline (before treatment) and 3 months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline (before treatment) and 3 months
measure: Change in Kidney Function
timeFrame: Baseline (before treatment) and 3 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: Chancheng District People's Hospital, Foshan City
state: Guangdong
Study officials:
References:
Clinical trial NCT06428162: An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community
Official title: an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Reaction
Drug Hypersensitivity
Drug Abuse
Drug Interaction
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs

Brief summary: Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported.


Eligibility criteria: Inclusion Criteria:

* all health care providers are invited to share in the study
* minimum experience required is one year in health carrier.
* accept sharing in the study

Exclusion Criteria:

* health care providers who refuse to complete all data required in the survey.
* fresh experience or participants who left health carrier

Primary outcomes:
measure: reported adverse drug reactions
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Deraya university
Study officials:
References:
Clinical trial NCT01194362: A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Official title: A Study to Establish Genomic Bio Signatures of Ascending Aortic Aneurysms in Patients With Bicuspid and Tricuspid Aortic Valve Disease With Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Keywords: aortic valve disease
gene expression
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital facility

Brief summary: For this study, blood and tissue samples will be collected in order to perform genetic testing to help researchers gather information about this disease and how and why it affects some patients more than others.

Detailed description: The cause of bicuspid aortic valve (BAV) and its associated co morbidities is unknown. There is, however, evidence supporting a genetic cause for the BAV, Pedigree analysis of familial clustering initially directed investigators to a genetic cause of BAV. Subsequent studies on BAV patients using linkage analysis have demonstrated high heritability.

Early identification of those patients with BAV disease who are at risk for ascending aneurysm formation and its complications may allow early intervention to prevent rupture, dissection and emergent cardiac surgery in at risk patients. Conversely, identification of those patients with BAVs not at risk for aortic aneurysm formation would delineate which patients do not need close follow up of aortic size or prophylactic ascending aortic replacement at time of aortic valve replacement.

Eligibility criteria: Inclusion Criteria:

* Patients \> or = to 18 years of age
* Presenting with aortic stenosis and to undergo elective aortic valve replacement or repair with or without aortic aneurysm dilation repair
* Able to sign informed consent document

Exclusion Criteria:

* Patients unable to provide informed consent for any reason
* Patients with predominant aortic regurgitation valve disease
* Patients with other known connective tissue disorders (such as Marfan's Syndrome, Ehlers-Danlos Syndrome)

Primary outcomes:
measure: Determine differences in genetic expression profiles using mRNA transcriptional analysis
timeFrame: 12 month
Secondary outcomes:
measure: Determine differences in the association between genetic expression profiles and aortic dilation in the two aortic valve disease groups.
timeFrame: 12 months
measure: Determine the association between expression of inflammatory markers/impaired response to oxidative stress and stenotic aortic valve disease.
timeFrame: 12 months
Other outcomes:
Locations:
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: The Heart Hospital Baylor Plano
name: William Brinkman, MD
role: PRINCIPAL_INVESTIGATOR
References: