louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03989726: Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation
Official title: Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2019-06-18
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation

Detailed description: In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.

Eligibility criteria: Inclusion Criteria:

* 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
4. Patients in the subject group vulnerable to clinical study
5. Patients who had undergone a prior catheter ablation for atrial fibrillation

Primary outcomes:
measure: Free from atrial arrhythmia at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Acute AF termination rate during the procedure
timeFrame: During the procedure
measure: Complication rate
timeFrame: 12 months
measure: Total procedure time, ablation time, fluoroscopy time
timeFrame: 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
Study officials:
References:
Clinical trial NCT03121326: The Study of Sarcopenia and Aging Biomarkers by the Metabolomics
Official title: The Study of Sarcopenia and Aging Biomarkers by the Metabolomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Aging
Keywords: Sarcopenia
Aging
Biomarkers
Metabolomics
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2017-04-20
Enrollment: 650
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 650 residents of the Chang Gung Health and Culture Village aged over 60.

Brief summary: With the rapid growth of the global elderly population, the studies of the biomarkers of the sarcopenia and aging are under investigation in different ways. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Detailed description: Metabolomics is the emerging platform technology to address the complexity of a living system. In translational research, metabolomics approaches may enable the detection of multiple disease risk factors and interactions, disease progression, and response of patients to a particular therapy with or without side effects. Metabolomics may provide comprehensive information and improve diagnosis and prognosis which are particularly promising in human complex degenerative diseases. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Eligibility criteria: Inclusion Criteria:

* residents of the Chang Gung Health and Culture Village
* mostly independent and do not require nursing assistance
* capable of managing their daily living activities
* aged ≧ 60

Exclusion Criteria:

* None.

Primary outcomes:
measure: The biomarkers of the sarcopenia and aging in senior adults.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chih-Ming Lin, M.D.
role: STUDY_CHAIR
affiliation: Chang Gung University
name: Mei-Ling Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262126: Virtual Reality for Non-cardiac Chest Pain
Official title: A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Diseases
Chest Pain
Keywords: Virtual reality
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).

Detailed description: The primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. As such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. As a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.

Eligibility criteria: Inclusion Criteria:

* Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)
* Negative prior cardiac evaluation (at a minimum, including electrocardiogram)
* Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality

Exclusion Criteria:

* Initiation of a proton pump inhibitor (PPI) within 8 weeks
* Major concomitant illness
* Current drug or alcohol use that that would interfere with adherence to study requirements
* Symptoms of vertigo or dizziness that would limit tolerability of the VR headset

Primary outcomes:
measure: Measure changes in GERD symptoms using the GERDQ questionnare
timeFrame: Week 2
measure: Measure changes in GERD quality of life using the GERD-HRQL questionnaire
timeFrame: Week 2
measure: Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire
timeFrame: Week 2
measure: Measure changes in GI symptom severity using the PAGI-SYM questionnaire
timeFrame: Week 2
measure: Measure changes in GI related patient assessment of quality of life using PAGI-QOL
timeFrame: Week 2
Secondary outcomes:
measure: Measure changes in anxiety and depression using the HADs scale
timeFrame: Week 2
measure: Measure changes in resilience using the brief resilience scale
timeFrame: Week 2
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Andree Koop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05569226: OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration
Official title: OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Lead sponsor: OKKO Health
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People with dry or wet age-related macular degeneration.

Brief summary: Smartphone apps have the potential to measure standard metrics of visual function. In addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. Smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. While there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy.

The OKKO Health app (www.okkohealth.com) is a smartphone app available on Apple iOS and Android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. The app has one game per function, each on average 1-2 minutes. There are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. This study will aim to validate these measures of visual function against gold standard clinical tests.


Eligibility criteria: Inclusion Criteria:

* Participants with AMD in at least one eye
* Willing to travel to the clinic in Exmouth/Bristol
* Able to hold and use a smartphone

Exclusion Criteria:

* Significant ocular pathology other than AMD
* Unable to provide written informed consent

Primary outcomes:
measure: Visual acuity
timeFrame: Day 1
measure: Contrast sensitivity
timeFrame: Day 1
measure: Colour sensitivity
timeFrame: Day 1
Secondary outcomes:
measure: Visual distortion
timeFrame: Day 1
measure: Optical coherence tomography (OCT)
timeFrame: Day 1
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol
Study officials:
affiliation: OKKO Health
name: Jamie Kawadler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00391326: Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients
Official title: Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Bivalirudin
Heparin
Bleeding
TIMI flow
STEMI
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: H:S Laegeambulance
First posted: 2006-10-23
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with STEMI transferred directly to primary PCI based og transmission of a prehospital ECG

Brief summary: The purpose of this study is to describe the efficacy and safety of prehospital administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial infarction redirected for primary angioplasty bypassing local hospitals, immediately after the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.

Detailed description: Primary angioplasty (pPCI) is the therapy of choice in patients with ST elevation acute myocardial infarction (STEMI) in Denmark. However, time is lost transferring patients from a local hospital to an invasive treatment centre. Time can be saved by redirecting STEMI patients to pPCI based on wireless prehospital 12-lead electrocardiogram (ECG) transmission directly to a cardiologist's handheld device. To prevent complications during the transportation of STEMI patients to the invasive hospital, patients are treated with oxygen, aspirin, clopidogrel, heparin, and nitro-glycerine in the ambulance. However, heparin use is cumbersome for the ambulance personnel since it must be kept at 5 degrees Celsius. An alternative to heparin may be bivalirudin, since it can be kept at room temperature and thus is easily administered in the prehospital setting.

Comparison: Heparin versus bivalirudin treatment. Efficacy is determined by thrombolysis in myocardial infarction (TIMI) flow in the first and final coronary angiogram. Safety is determined by the rate of bleeding complication.

Eligibility criteria: Inclusion Criteria:

* ST elevation acute myocardial infarction patients redirected for primary angioplasty
* Symptoms less than 12 hours

Exclusion Criteria:

* Contraindications against primary angioplasty

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: H:S Lægeambulance
state: V
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Peter Clemmsensen, MD. phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00167726: Neuraxial and Neurolytic Analgesia for Intractable Pain
Official title: Neuraxial and Neurolytic Analgesia for Intractable Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective case series analysis. Subjects over the age of 18 who are offered neuraxial (epidural or intrathecal) analgesia or neurolytic procedures (e.g. celiac, hypogastric, or sacral nerve plexus block) to treat intractable pain through the UW Interventional Pain Program.

Brief summary: The purpose of this study is to collect longitudinal data on outcomes of neuraxial or neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that we may contribute to the growing evidence for or against these therapies and to provide data for ongoing quality improvement activities.


Eligibility criteria: Inclusion Criteria:

* treated for intractable pain by the UW Interventional Pain Treatment program
* inpatient or outpatient

Exclusion Criteria:

* less than 18 years of age

Primary outcomes:
measure: Prospective review of pain
timeFrame: six years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nalini Sehgal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679726: The Effect of Foot Reflexology in Intensive Care Nurses
Official title: The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Pain
Stress
Nurse
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled experimental research design to examine the effect of foot reflexology applied to nurses working in the intensive care unit on stress, fatigue and low back pain.

Detailed description: The universe of the research consisted of a total of 90 nurses working in a university and a public hospital in a city. Among the nurses, those who meet the criteria for inclusion in the study will form the sample. Assignment to the intervention and control group will be determined in the computer environment using a simple randomization method (www.randomizer.org/). The number of samples was determined using power analysis. It was decided to recruit a total of 42 nurses, 21 for each group.

Eligibility criteria: Inclusion Criteria:

* -Intensive care unit nurse
* Those aged 18 to 65 years
* Working in intensive care for at least 6 months
* Back pain for at least 3 months
* Not pregnant, non-breastfeeding
* Having a regular menstrual cycle
* Vascular disease and foot fracture, wound, scar, skin damage etc. no situation
* Volunteered to participate in the research
* Not using antidepressants, sleeping pills, etc.

Exclusion Criteria:

* Working in intensive care for less than 6 months
* No chronic low back pain
* Pregnant, lactating
* Do not have a regular menstrual cycle
* Vascular disease and foot fracture, wound, scar, skin damage etc. situation found
* Using antidepressants, sleeping pills, etc.

Primary outcomes:
measure: pain severity
timeFrame: pre test
measure: fatique
timeFrame: pre test
measure: stress
timeFrame: pre test
Secondary outcomes:
measure: pain severity
timeFrame: post test(at the end of the 4th week)
measure: fatique
timeFrame: post test (at the end of the 4th week)
measure: stress
timeFrame: post test(at the end of the 4th week)
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Ayşe Gül Parlak
Study officials:
affiliation: Kafkas University
name: Ayşe Gül Parlak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00278226: Motivational Program for Smokers Enrolled in a Methadone Maintenance Program
Official title: Smoking Cessation Among Methadone Maintained Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-18
Enrollment: 398
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: PREVENTION

Brief summary: RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.

PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.

Detailed description: OBJECTIVES:

* Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.

OUTLINE: Patients are assigned to 1 of 2 groups.

* Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
* Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.

All patients will be offered a 2- to 3-month supply of nicotine patches.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Must be currently enrolled in a methadone maintenance program
* Smokes at least 10 cigarettes a day

PATIENT CHARACTERISTICS:

* Not pregnant
* No concurrent medical condition that precludes the use of nicotine patches

PRIOR CONCURRENT THERAPY:

* No concurrent use of other nicotine replacement therapy

Primary outcomes:
measure: Nicotine Abstinence
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital Comprehensive Cancer Center
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael Stein, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04481126: Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography
Official title: Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Renal Insufficiency
Acute Coronary Syndrome
Keywords: Acute Renal Insufficiency
Acute Coronary Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized in Ambroise Paré hospital in the period between Jan 2017 to Jul 2019, who have been an urgent coronarography, and have a renal insufficiency needing dialysis.

Brief summary: The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital.

The secondary objectives are:

* identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography.
* establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* patient aged ≥ 18 years;
* evocative symptoms of myocardiac ischemia: typical chest pain; ST-segment elevation and 1 mm in two consecutive peripheral leads and 2 mm in two consecutive precordial derivations, or appearance of a bloc of left branch of novo;
* need urgent coronarography;
* Covered by french social security scheme included CMU.

Exclusion Criteria:

* dialysed patient for chronic renal insufficiency;
* cardio-resporatory arrest;
* cardiogenic choc state;
* prior emergency passage to hospital;
* patient under tutor, gardianship;
* patient covered by french AME scheme;
* pregnant women or breastfeeding;
* all medical, psychological or social situation which should influents the compliance to protocol according to investigator;
* patient refusal.

Primary outcomes:
measure: incidence of acute renal failure
timeFrame: at baselin and at 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Nephrology department, Ambroise Paré hospital, APHP
Study officials:
affiliation: Nephrology department, Ambroise Paré hospital, APHP
name: Paul GABARRE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology department, Ambroise Paré hospital, APHP
name: Eve Vilaine, MD
role: STUDY_DIRECTOR
References: