louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04000087: ECG AI-Guided Screening for Low Ejection Fraction
Official title: Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Left Ventricular Systolic Dysfunction (Disorder)
Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 358
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: This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).

Exclusion Criteria:

* Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.

Primary outcomes:
measure: New Diagnosis of Low Ejection Fraction (defined as ejection fraction ≤50%)
timeFrame: Within 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiaoxi Yao, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Peter Noseworthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao X, McCoy RG, Friedman PA, Shah ND, Barry BA, Behnken EM, Inselman JW, Attia ZI, Noseworthy PA. ECG AI-Guided Screening for Low Ejection Fraction (EAGLE): Rationale and design of a pragmatic cluster randomized trial. Am Heart J. 2020 Jan;219:31-36. doi: 10.1016/j.ahj.2019.10.007. Epub 2019 Oct 25.
citation: Rushlow DR, Croghan IT, Inselman JW, Thacher TD, Friedman PA, Yao X, Pellikka PA, Lopez-Jimenez F, Bernard ME, Barry BA, Attia IZ, Misra A, Foss RM, Molling PE, Rosas SL, Noseworthy PA. Clinician Adoption of an Artificial Intelligence Algorithm to Detect Left Ventricular Systolic Dysfunction in Primary Care. Mayo Clin Proc. 2022 Nov;97(11):2076-2085. doi: 10.1016/j.mayocp.2022.04.008.
citation: Yao X, Rushlow DR, Inselman JW, McCoy RG, Thacher TD, Behnken EM, Bernard ME, Rosas SL, Akfaly A, Misra A, Molling PE, Krien JS, Foss RM, Barry BA, Siontis KC, Kapa S, Pellikka PA, Lopez-Jimenez F, Attia ZI, Shah ND, Friedman PA, Noseworthy PA. Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med. 2021 May;27(5):815-819. doi: 10.1038/s41591-021-01335-4. Epub 2021 May 6.
Clinical trial NCT05653687: Total Hip Arthroplasty: Fluoroscopy vs Freehand
Official title: A Randomized, Monocentric Investigator-initiated Clinical Investigation Comparing Fluoroscopy Versus Freehand in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Fluoroscopy
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare total hip arthroplasty intervention executed with or without the use of intraoperative fluoroscopy in terms of positioning of the hip prosthesis. The comparison will be made on post-operative follow-up X-ray performed as per clinical practice, in order to verify if intraoperative fluoroscopy provides better prosthesis components positioning or not.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral primary THA through DAA
* Patients aged 18-90 years old.
* Patients with a BMI \>18 and \<35.
* Patients able to provide informed consent.
* Informed consent as documented by signature.

Exclusion Criteria:

* Revision THA.
* Women who are pregnant or breast feeding.
* Presence of other clinically significant concomitant disease states (ASA IV).
* Previous enrolment into the current study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: Acetabular component anteversion
timeFrame: 2 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale
state: Ticino
Study officials:
References:
Clinical trial NCT06661187: Simple Psychological Interventions and Cryoanalgesia
Official title: The Effect of Using Simple Psychological Interventions and Cryoanalgesia for Reducing Arterial Puncture Pain and Anxiety in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arterial Puncture
Keywords: Cryoanalgesia
Arterial Puncture
Anxiety
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group one will use cryoanalgesia group two will use simple psychological instruction control group
Primary purpose: TREATMENT

Brief summary: This study aims to explore the effect of using simple psychological interventions and cryoanalgesia for reducing arterial punctures pain and anxiety in critically ill patients

Detailed description: The present study will be carried out in two interventions Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage.

Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders.
* Consciousness patient required arterial puncture

Exclusion Criteria:

* Unconsciousness patients Patients with complicated site from arterial puncture

Primary outcomes:
measure: Severity of pain using Behavioral Pain Scale
timeFrame: Three observations after the end arterial puncture procedure
measure: Level of anxiety using the Hamilton Anxiety Rating Scale
timeFrame: Three observations after the end arterial puncture procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour university
city: Damanhūr
country: Egypt
facility: Faculty Of Nursing
Study officials:
References:
Clinical trial NCT03710187: HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
Official title: Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: University of Tennessee Medical Center
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 84
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: This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock (defined as 24 hours vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill septic shock patients.

Detailed description: For three consecutive months, side 1 of the medical critical care unit (MCC1) will receive hydrocortisone alone and side 2 (MCC2) will receive the combination of hydrocortisone and fludrocortisone. After the initial three months, this will be flipped and patients admitted to MCC1 will receive the combination while patients in MCC2 will receive hydrocortisone alone for three consecutive months. This change in group assignments will occur to account for the difference in number of beds between MCC1 and MCC2, and to minimize the potential differences in patient acuity by location.

Eligibility criteria: Inclusion Criteria:

* Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
* Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

* Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
* Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
* Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
* Patients not appropriate for study inclusion as determined by provider discretion
* Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
* Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
* Any patient receiving greater than one dose of hydrocortisone 100 mg
* Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone

Primary outcomes:
measure: Time to Resolution of Shock
timeFrame: Up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT05458687: Traditional Chinese Medicine for Complications in Critically Ill Patients
Official title: Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill Patients
Keywords: Traditional Chinese Medicine, intensive care,
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

Detailed description: Introduction: Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.

Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.

Eligibility criteria: Inclusion Criteria:

* Age 20-90
* newly intensive care unit admission (\<48 hours)
* Two or less inotropic medicine prescribed

Exclusion Criteria:

* Clinically unstable: receiving more than inotropic agents.
* Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times

Primary outcomes:
measure: The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.
timeFrame: ICDSC、RASS、BPS record by everyday.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT00694187: Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Term Treatment of Insomnia
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zaleplon or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two Period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02859987: Randomized Controlled Trial of Ultrasound-guided Versus Landmark Technique for Peripherally Inserted Central Catheter (PICC) Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PICC Placement
Keywords: US
Nursing Services
Lead sponsor: Equipo de Terapia Intravenosa
Sponsor class: OTHER
Collaborators: name: Hospital San Carlos, Madrid
First posted: 2016-08-09
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Peripherally Inserted Central Catheter (PICC) are intravascular devices used on patients undergoing IV therapy. Insertion of these catheters can be achieved either by using the anatomical landmarks for the veins or using ultrasound guidance. The guidelines recommend the use of ultrasound guidance for central venous access catheterization to facilitate central venous cannulation (CVC) and to reduce the risk of complications, but the scientific evidence is limited and heterogeneous.

This is a prospective randomized clinical trial in adults patients requiring peripherally inserted central catheter (PICC) placement for intravenous therapy.

The principal aim of this randomized clinical trial is to evaluate the effectiveness of ultrasound-guidance technique for successfully peripherally central venous catheterisation in the first attempt versus landmark method, in the context of PICC cannulation.

Patients are randomized (1:1) in two groups: Control arm (landmark technique) versus Experimental group (ultrasound guidance technique). In order to avoid expected biases the investigators stratified the cases by difficulty for venous cannulation. Crossover was allowed if catheterisation could not be reached after two unsuccessful venipunctures, to prevent suffering of the patients and troubles in its care.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent.
* Patients with indication of PICC insertion for long-term intravenous therapy

Exclusion Criteria:

* Peripheral vascular disease
* Injecting drug users

Primary outcomes:
measure: Evidence of catheter inserted at first attempt, correctly located (after chest X-ray performed) and proper working, confirmed by the nurse
timeFrame: Within the first 6 hours after placement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Clinico San Carlos
name: Maria Montealegre, RN, IV Nurse
role: STUDY_DIRECTOR
References:
Clinical trial NCT06251687: Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Official title: Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Fibrosis
Transbronchial Cryobiopsy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.


Eligibility criteria: Inclusion Criteria:

Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

Exclusion Criteria:

Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Primary outcomes:
measure: the diagnostic performance of transbronchial cryobiopsy（TBLC）
timeFrame: 1 month after transbronchial cryobiopsy
Secondary outcomes:
measure: the safety of transbronchial cryobiopsy（TBLC)
timeFrame: 7 days and 1 month after transbronchial cryobiopsy
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00456287: Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome
Official title: Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Cardiovascular Diseases
Keywords: Sleep Apnea
Clotting- fibrinolysis patterns
Platelet function markers
Endothelial dysfunction
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Fundacion Caubet-Cimera Islas Baleares
First posted: 2007-04-04
Enrollment: 40
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.

Detailed description: The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night.

Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night

DESIGN: Prospective and controlled study

METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:

a) medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.

Eligibility criteria: Inclusion Criteria:

* Apnea-Hypopnea Index \> 15

Exclusion Criteria:

* Presence of any chronic disease
* Presence of cardiovascular disease
* Refusal to sign informed consent
* Drug addiction and/or alcoholism
* Any medication two weeks before

Primary outcomes:
measure: To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Secondary outcomes:
measure: CPAP (Continuous Positive Airway Pressure) effect on studied variables
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Baleares
Study officials:
affiliation: Hospital Universitario Son Dureta
name: Antonia Barceló, MD
role: PRINCIPAL_INVESTIGATOR
References: