louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02440620: Cardiac Toxicity in Medical Treatment of Breast Cancer
Official title: Cardiac Toxicity in Medical Treatment of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Breast Cancer
Keywords: Heart failure related to medical treatment of breast cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2015-05-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HER2 positive breast cancer in adjuvant treatment with trastuzumab.

Brief summary: This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.

In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HER2 positive breast cancer
* Adjuvant treatment with trastuzumab

Exclusion Criteria:

* Left ventricle ejection fraction (LVEF) \<50%
* Chronic or persistent atrial fibrillation
* History of moderate or severe valvular heart disease.

Primary outcomes:
measure: Global longitudinal strain by two dimentional speckle tracking.
timeFrame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
measure: Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).
timeFrame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Odense c
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jacob Moeller, MD, DMsc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02960620: Therasphere for Unresectable Primary or Secondary Liver Neoplasia
Official title: A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Liver Cancer
Liver Neoplasms
HepatoCellular Carcinoma
Keywords: Humanitarian Device Exemption
Liver Disease
HDE #980006
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Biocompatibles UK Ltd
name: BTG International Inc.
First posted: 2016-11-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.


Eligibility criteria: Inclusion Criteria:

* Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
* Potential candidates are those diagnosed with primary or secondary liver neoplasia. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC).
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
* Life expectancy ≥ 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Any other liver therapy planned for cancer treatment
* Uncorrectable flow to the gastrointestinal tract
* Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations
* Significant extrahepatic disease representing imminent life-threatening outcome
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Junsung Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04178720: Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Official title: Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lens
Daily Wear
Vision Correction
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 119
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 clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Detailed description: Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* 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.
* Habitually wearing Biofinity contact lenses.
* Monovision contact lens wearers.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance VA (logMAR) With Study Lenses - Completed Eyes
timeFrame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
measure: Distance VA (logMAR) With Study Lenses - Discontinued Eyes
timeFrame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Longwood
country: United States
facility: Alcon Investigative Site
state: Florida
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Medina
country: United States
facility: Alcon Investigative Site
state: Minnesota
city: Granville
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06880120: Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease
Official title: Improvement of Diagnostic Accuracy of Seismocardiography and Gyrocardiography for Non-Invasive Coronary Artery Disease Diagnosis: A Comparison With Coronary Artery Calcium Computed Tomography, Coronary Computed Tomography Angiography, and Invasive Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Keywords: coronary artery disease
Seismocardiography
CardioClin
Lead sponsor: Heart Force Medical Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 1534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure small vibrations on the chest caused by the heartbeat using highly sensitive sensors. The goal is to determine whether this method, using the CardioClin device, can accurately detect CAD compared to standard tests like coronary calcium scans (CAC-CT), CT angiography (CCTA), and invasive coronary angiography (ICA).

Patients who are already scheduled for one of these standard tests will also undergo SCG/GCG testing. The study will compare results to see if the new method provides a reliable, cost-effective, and radiation-free alternative for diagnosing CAD.

This research could help improve early detection of heart disease without the need for invasive procedures.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older.
* Suspected CAD, based on clinical evaluation.
* Able to provide informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Presence of implanted cardiac devices (e.g., pacemakers, implantable cardioverter defibrillators) that may interfere with SCG/GCG signal acquisition.
* Severe arrhythmias that may affect signal interpretation.
* Inability to maintain required testing positions (supine and sitting).
* Medical conditions preventing informed consent (e.g., severe cognitive impairment).

Primary outcomes:
measure: Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection
timeFrame: Baseline (Day 1, before standard diagnostic procedures).
Secondary outcomes:
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)
Study officials:
References:
Clinical trial NCT02252120: Laryngeal Mask Airway Supreme Versus Laryngeal Tube
Official title: Laryngeal Mask Airway Supreme Versus Laryngeal Tube in Non-paralysed, Anesthetized Children. A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position Using the Size 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Anesthesia Outcome
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: University of Salzburg
First posted: 2014-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients

Detailed description: The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well studied laryngeal mask airway. Both devices have a drain tube to allow access to the gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The investigators hypothesized that design differences should lead to differences in efficacy of seal and anatomic position. In this randomized, crossover study, the investigators test the hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* age 1.5 - 9 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<18 months, \>9 years)
* weight (\<10 kg, \>25 kg)
* a known difficult airway
* risk of aspiration

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 5 Min
Secondary outcomes:
measure: Fiberoptic position
timeFrame: 5 Min
Other outcomes:
measure: Ease of insertion
timeFrame: 1 Min
Locations:
Study officials:
affiliation: Schulthess Klinik, Lengghalde 2, 8008 Zürich
name: Christian Keller, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056820: Comparison of Apnea Tolerance in Two Positions of Patients With BMI 30-40
Official title: Comparison of Apnea Tolerance in Two Positions of Patients With Body Mass Index (BMI) 30-40
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Surgery
Keywords: tracheal intubation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apnea time (TAT) after induction of general anesthesia in patients with a body mass index (BMI) of 30-40.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Body Mass Index (BMI) of 30-40
* Scheduled for an elective surgery that requires tracheal intubation

Exclusion Criteria:

* Patients with abnormalities of the upper airway that require awake tracheal intubation
* Asthma
* Chronic obstructive pulmonary disease
* Congestive heart failure
* Pregnant patients

Primary outcomes:
measure: Tolerable Apnea Time (TAT)
timeFrame: Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes
Secondary outcomes:
measure: Length of time to intubation (TTI)
timeFrame: Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes
measure: Peripheral arterial hemoglobin oxygen saturation (SpO2) trough
timeFrame: Time until SpO2 decreased to 92%, up to 8 minutes
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: Mirsad Dupanović, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02657720: Comparison Between Different Technologies That Measure Respiratory Rate
Official title: Comparison Between Different Technologies That Measure Respiratory Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Respiratory Conditions for Adults
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Herzog Hospital
First posted: 2016-01-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress. Continuous monitoring of respiration rate is performed in patients under different clinical conditions, including post-surgery or different respiratory diseases. Clinician observation, pulse oximetry, and capnography are used individually or in combination to monitor ventilation during sedation and on post-surgical patients. The American Society of Anesthesiologists mandates the monitoring of respiration by measuring end tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques for respiration rate measurement include different technologies such as acoustic respiratory rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain respiratory conditions.


Eligibility criteria: Inclusion Criteria:

* Without Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
* Without Clinical diagnosis of heart disease.

Exclusion Criteria:

* Want to be excluded
* Breathing difficulties
* Unabling or unwilling to follow the protocol.
* Contact allergy to the adhesive neck sensor.

Primary outcomes:
measure: The influence of different breathing rates.on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.
timeFrame: six months
Secondary outcomes:
measure: The influence of hearing or performing noises on the accuracy of respiratory rates in breaths per minute as measured by the tested devices compared to the reference device.
timeFrame: six months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Herzog Hospital
name: Michal Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086020: Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Official title: Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: IVUS
coronary plaque
regression
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.


Eligibility criteria: Inclusion Criteria:

* Willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria:

* Patients was treated by statins before randomization
* Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
* ST elevation myocardial infarction less than 7 days
* Without informed consent
* Abnormal liver function before randomization, (AST, ALT ≥ULN)
* Active hepatitis or muscular disease
* Impaired renal function with serum creatinine level \> 3mg/dl
* Impaired left ventricular function with LVEF \> 30%
* Participate in other studies

Primary outcomes:
measure: change of coronary artery plaque volume
timeFrame: 1 year
Secondary outcomes:
measure: composite of adverse cardiac events
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital,
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weifeng Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00988520: Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)
Official title: Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 Following a Single Intubating Dose in Adult Patients Undergoing Operation Under Sevoflurane or Propofol Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Neuromuscular Blocking Agents
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.


Eligibility criteria: Inclusion Criteria:

* Subjects at least 20 but under 65 years of age.
* Subjects of asa class 1, 2 or 3 for general elective surgery.
* Subjects who are not considered to be pregnant.
* Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of 2-5 hours.
* Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
* Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.

Exclusion Criteria:

* Subjects with renal dysfunction as a complication or in the history.
* Subjects with serum creatinine level greater than 1.6 mg/dL.
* Subjects with severe hepatic dysfunction as a complication or in the history.
* Subjects with known significant metabolic or neuromuscular disorders.
* Subjects with showing dyspnea, airway obstruction or bronchial asthma.
* Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.
* Subjects with atopic diseases.
* Subjects who have developed any systemic allergic symptoms related to drugs or general anesthesia.
* Subjects receiving antihistamines and antiallergic agents for 1 month or more.
* Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
* Subjects under hypothermic anesthesia.
* Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
* Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or sub-investigator.

Primary outcomes:
measure: Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
timeFrame: 90 minutes after start of continuous infusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: