louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06973031: A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Official title: A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation
Keywords: Pulsed Field Ablation
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.


Eligibility criteria: Key inclusion criteria:

* A diagnosis of recurrent symptomatic paroxysmal or persistent AF
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

* Long-standing persistent AF (sustained \>12 months)
* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* History of thromboembolic events within the past six months
* Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
* Any cardiac surgery within the previous six months
* Prior left atrial ablation or surgical procedure
* Presence of an implanted cardiac device
* Body mass index (BMI) \>40 kg/m\^2
* Left ventricular ejection fraction (LVEF) \<35%
* Anterior-posterior left atrial (LA) diameter \>55mm

Primary outcomes:
measure: Effectiveness endpoint
timeFrame: 12 months
measure: Safety endpoint
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH Kaiserslautern
Study officials:
References:
Clinical trial NCT05015231: Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients
Official title: Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients with a functioning graft and a patent hemodialysis fistula

Brief summary: Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Patients wishing to close the fistula and planned for surgical fistula closure
* eGFR CKD EPI ≥ 45 ml/min/1.73m2 at one year post transplantation
* Stable eGFR within the past 6 months
* Controlled blood pressure

Exclusion Criteria:

* Kidney Transplantation \< 12 months before fistula closure
* Proteinuria \> 500mg/d
* Presence of donor specific antibodies
* Rejection within the past 6 months
* BK virus replication within the past 3 months
* Cardiac pacemaker, which is not compatible with MRI
* Claustrophobia

Primary outcomes:
measure: Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access
timeFrame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
measure: Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access
timeFrame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Secondary outcomes:
measure: Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure
timeFrame: evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Nephrology
name: Thomas Müller, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990431: Ablative Fractional Lasers to Treat Peri-orbital Rhytides
Official title: Ablative Fractional Lasers (CO2 and Er:YAG): A Randomized Controlled Blinded Split-face Trial of the Treatment of Peri-orbital Rhytides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peri-orbital Rhytides
Keywords: skin aging
laser surgery
fractional photothermolysis
comparative study
Ablative fractional treatment of peri-orbital rhytides
Lead sponsor: Laserklinik Karlsruhe
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study compares these modalities in a randomized controlled blinded split-face study design:

28 patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO2 and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score, profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment).


Eligibility criteria: Inclusion Criteria:

* age 40-55
* mild to moderate peri-orbital rhytides

Exclusion Criteria:

* unrealistic expectations
* inability to meet follow-up criteria
* Fitzpatrick skin phototype \>III
* coagulation disorders or anti-coagulant treatment
* allergy to lidocaine or tetracaine
* oral isotretinoin within the last 6 months
* any active skin disease within the treatment areas (e. g., cancer, autoimmune disease)
* synthetic implants in the treatment area
* facial cosmetic procedures affecting the treatment area within the last 6 months
* photosensitizing medications (e. g., tetracycline, gold)
* history of keloid formation
* pregnancy

Primary outcomes:
measure: Objective wrinkle depth
timeFrame: 3 months
measure: Wrinkle severity (according to Fitzpatrick´s wrinkle score)
timeFrame: 3 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Laserklinik Karlsruhe
Study officials:
affiliation: Laserklinik Karlsruhe
name: Syrus Karsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00907231: Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Myocardial Infarction
Chest Pain
Acute Coronary Syndrome
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 400 adults presenting to the ED with possible AMI will be enrolled.

Brief summary: This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of enrollment
* Presenting to the ED within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of AMI or ACS and with an initial ECG non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (NOTE: Subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ED presentation is within 6 hours of symptom onset.)
* Experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (Note: Subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.)

Exclusion Criteria:

* Patient (or Legal Representative) unable or unwilling to provide written informed consent.
* Patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months.
* Vulnerable populations as deemed inappropriate for study by site principal investigator.
* ST-elevation or other ECG criteria that result that is diagnostic for AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics6.
* Pulmonary Edema requiring CPAP, BIPAP, or mechanical ventilation
* Tachyarrhythmias (SVT, V-Tach, rapid atrial fib)
* End Stage Renal Disease on Hemodialysis
* Cardiac Arrest prior to arrival
* Implantable Defibrillator firing prior to arrival
* Hemodynamically unstable patients
* Trauma injury to the chest

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Johnson City
country: United States
facility: Mountain States Health Alliance
state: Tennessee
Study officials:
References:
Clinical trial NCT01424631: Single Incision Versus Conventional Laparoscopic Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* perforation with peritonitis
* lower abdominal scar
* contraindications to laparoscopy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01050231: Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Official title: Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: stroke
cerebrovascular accident
robot
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
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 develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.

Detailed description: Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 73
* Sustained single stroke at least three months previously
* Minimal to moderate lost motor control of the arm after stroke

Exclusion Criteria:

* Concurrent severe medical problems
* Severe cognitive dysfunction
* Severe neglect or apraxia
* Severe visual deficits
* Significant subluxation of the shoulder
* Presence of severe elbow or wrist contracture
* Any metal implants or surgical clips or mechanical devices
* Metallic hardware on scalp region
* prior diagnosis of seizure and epilepsy
* severe migraine headache
* currently pregnant or lactating
* claustrophobic
* currently taking medication that lower seizure threshold

Primary outcomes:
measure: Box & Blocks Test
timeFrame: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: David J Reinkensmeyer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES. J Neuroeng Rehabil. 2013 Dec 19;10:112. doi: 10.1186/1743-0003-10-112.
Clinical trial NCT00826631: How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Official title: How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyper-Alimentation
Healthy
Keywords: weight
metabolism
cholesterol
insulin
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and hepatic triglyceride content (HTGC)and metabolism.

Design: Prospective interventional study with parallel control group. Setting University Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean (SD) age of 26 (6.6) years and a matched control group.

Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by eating at least two fast food-based meals a day with the goal to double the regular caloric intake in combination with adoption of a sedentary lifestyle for four weeks.

Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton nuclear magnetic resonance-spectroscopy at baseline and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Healthy non-obese subjects

Exclusion Criteria:

* General diseases, obesity.

Primary outcomes:
measure: weight gain
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
Study officials:
References:
citation: Kechagias S, Ernersson A, Dahlqvist O, Lundberg P, Lindstrom T, Nystrom FH; Fast Food Study Group. Fast-food-based hyper-alimentation can induce rapid and profound elevation of serum alanine aminotransferase in healthy subjects. Gut. 2008 May;57(5):649-54. doi: 10.1136/gut.2007.131797. Epub 2008 Feb 14.
citation: Lindstrom T, Kechagias S, Carlsson M, Nystrom FH; Fast Food Study Group. Transient increase in HDL-cholesterol during weight gain by hyperalimentation in healthy subjects. Obesity (Silver Spring). 2011 Apr;19(4):812-7. doi: 10.1038/oby.2010.190. Epub 2010 Sep 2.
Clinical trial NCT00327431: Relationship of Genes and Life Events to Blood Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Psychosocial Factors
Keywords: Hypertension
Blood Pressure
Psychosocial Factors
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Research suggests that blood pressure is influenced by both genetic and environmental factors. The goal of this study is to find genes that play a role in blood pressure and understand how they interact with life events (such as job stress) to influence blood pressure. We hypothesize that the gene for endothelin-1 is associated with increased blood pressure. Further, we predict that this genetic relationship is moderated by psychosocial stress factors, specifically job strain and marital cohesion.


Eligibility criteria: Inclusion Criteria:

* Previous participation in a study of psychosocial stressors and blood pressure (Double Exposure Study) and agreement to participate in follow-up studies

Exclusion Criteria:

* Withdrawal of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Brian Baker, MB, ChB
role: STUDY_CHAIR
affiliation: Sunnybrook Health Sciences Centre
name: Sheldon Tobe, MD
role: STUDY_CHAIR
References:
citation: Tobe SW, Kiss A, Szalai JP, Perkins N, Tsigoulis M, Baker B. Impact of job and marital strain on ambulatory blood pressure results from the double exposure study. Am J Hypertens. 2005 Aug;18(8):1046-51. doi: 10.1016/j.amjhyper.2005.03.734.
Clinical trial NCT03138031: Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
Official title: Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Percutaneuos Ethanol alcohol injection
Lead sponsor: The National Ribat University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 23
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment. Prospective and non-randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.

Detailed description: Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing (PAT or PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.

Eligibility criteria: Inclusion Criteria:

* Review and sign informed consent;
* Between 15 and 80 years of age at time of trial enrollment;
* Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
* Radiologically documented tumor size of \> 5 centimeters;
* Radiologically documented liver cirrhosis.

Exclusion Criteria:

* American Anesthesia Association (ASA) Class IV or V and/or any
* contraindications to general anesthesia;
* Uncontrollable ascites;
* Deep persistent jaundice;
* Hepatic encephalopathy;
* Coagulopathy;
* Severe thrombocytopenia;
* Unable or unwilling to attend follow up visits and examinations;
* Other associated surgical procedure;

Primary outcomes:
measure: Overall survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 3 years
measure: Major complications' rate
timeFrame: 3 years
measure: Tumor response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Ribat University Hospital
Study officials:
affiliation: The National Ribat University
name: Osama M Elsanousi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ribat University Hospital
name: Murtada M Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06332131: Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
Official title: Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Coronary Microvascular Dysfunction
Cardiotoxicity
Breast Cancer
Lung Cancer (NSCLC)
Keywords: cancer therapy related cardiotoxicity
Immune checkpoint inhibitor therapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast or lung cancer planned for treatment that includes pembrolizumab.

Brief summary: This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Either diagnosis of breast cancer with plan for treatment according to the Keynote 522 regimen or non-small-cell lung cancer planned for neoadjuvant treatment that includes pembrolizumab
* Able to provide written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding:
* Prior treatment with ICI therapy.
* Vulnerable patients, including pregnant women and prisoners
* Absolute Contraindication to rest/vasodilator stress PET/CT

Primary outcomes:
measure: Incidence of new abnormal myocardial blood flow reserve (MBFR)
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of major cardiovascular events
timeFrame: 3 months
measure: Coronary calcium score
timeFrame: 3 month
measure: All cause mortality
timeFrame: 3 months
measure: Cardiovascular specific mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Marielle Scherrer-Crosbie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: