louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05080023: Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index
Official title: Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enhanced External Counterpulsation (EECP)
Cardiac Output
Cardiac Force Index
Keywords: cardiac force index
Cardiac Output
Enhanced External Counterpulsation (EECP)
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Dr. Chiang, Shang-lin
name: Dr. Liang-Cheng Chen
First posted: 2021-10-15
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects can walk with a cardiac force meter.

Brief summary: Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. The patent of the Cardiac Force Index (CFI), invented by Professor Chu, is a method to detect the state of cardiac motion. Recent studies have confirmed Enhanced External Counterpulsation (EECP) can increase cardiopulmonary fitness and maximal oxygen consumption. Our aim is to investigate the differences and effects of CFI between two groups with and without 4 weeks of EECP intervention, therefore, to find out the relationship between CFI and maximum oxygen consumption (VO2max).

Methods: A pre and post-test control group was designed. A total of 53 military students (33 males and 20 females) were recruited and divided into intervention and control groups. A 2000-meter running and maximum oxygen consumption tests were performed pre and post-test. The intervention group was conducted a 4 week (3 times per week/30 minutes) EECP intervention.


Eligibility criteria: Inclusion Criteria:

* can walk.

Exclusion Criteria:

* disabilities.

Primary outcomes:
measure: Enhanced External Counterpulsation (EECP) on cardiac force index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Local Clinics
city: Kaohsiung
country: Taiwan
facility: Local Clinics
city: Taichung
country: Taiwan
facility: Local Clinics
city: Taipei
country: Taiwan
facility: National Defense Medical Center
city: Taoyuan
country: Taiwan
facility: Local Clinics
Study officials:
References:
citation: Hsiao PJ, Chiu CC, Lin KH, Hu FK, Tsai PJ, Wu CT, Pang YK, Lin Y, Kuo MH, Chen KH, Wu YS, Wu HY, Chang YT, Chang YT, Cheng CS, Chuu CP, Lin FH, Chang CW, Li YK, Chan JS, Chu CM. Usability of Wearable Devices With a Novel Cardiac Force Index for Estimating the Dynamic Cardiac Function: Observational Study. JMIR Mhealth Uhealth. 2020 Jul 21;8(7):e15331. doi: 10.2196/15331.
citation: Chiang KT, Tu MY, Lin YJ, Hsin YH, Chiu YL, Li FL, Chen HH, Lai CY. A Cardiac Force Index Applied to the G Tolerance Test and Surveillance among Male Military Aircrew. Int J Environ Res Public Health. 2021 Aug 21;18(16):8832. doi: 10.3390/ijerph18168832.
Clinical trial NCT05440123: Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation
Official title: Bronchopulmonary Cancer Screening Program and Primary Cardiovascular Prevention, Early Management of COPD and Smoking Cessation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: the Rate of Participation in Screening for PBC
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 55 to 74, smokers with more than 20 active pack-years or weaned for less than 15 years.

Brief summary: The study consists of recruiting a target population by sending a letter from the Regional Center for Cancer Screening in Ile de France.

In the screening program, a battery of examinations will be carried out at inclusion, one year, 2 years, 3 years, 4 years and 5 years.

Detailed description: The patients will be recruited by correspondence by by sending a letter from the Regional Center for Cancer Screening in Ile de France.

When the patient has agreed to participate, a screening program will be carried out The screening program includes performing a low-dose chest CT scan (STBD), spirometry, blood sampling (biobank + screening for cardiovascular risk factors) on inclusion, at 1 year and at 2 years. Subsequently, a telephone interview will be scheduled for 3 years to collect medical information, for a total follow-up period of 5 years. At each visit, a structured offer of smoking cessation will be proposed and a collection of the quality of life will be carried out. Each year, a telephone call from participants will be scheduled in order to maximize participation

Eligibility criteria: Inclusion Criteria:

* Women and men
* Age: 55 to 74 years old
* Smokers at more than 20 pack-years weaned for less than 15 years
* Affiliated to a social security organization

Exclusion Criteria:

* Presence of signs of PBC
* Subjects with a personal history of PBC of less than 5 years or under treatment
* Presence of serious comorbidities involving the vital prognosis at 6 months
* Subjects who have already benefited from a chest CT scan less than one year old.
* Refusal to participate in the study
* Absence of exposure to tobacco or insufficient exposure to tobacco or withdrawal \> 15 years
* Patient on long-term oxygen therapy
* Metal implants (thorax, spine) which can cause a deterioration in the quality of the image of the low dose scanner
* Subject included in another study protocol

Primary outcomes:
measure: Rate of population participation in PBC screening
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02782923: Driving After Cervical Spine Surgery
Official title: Driving After Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Disease
Keywords: Cervical Spine Surgery
Simulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-center, prospective controlled simulation study designed comparing and evaluating the driving performance of subjects who have had cervical spine surgery and the use of a validated driving simulator. To date, there haven't been evidence-based recommendations to determine a patient's "fitness to drive" in the peri-operative or postoperative state. The objective of this study is to delineate the effect cervical spine procedures have on driving performance in the peri-operative time period. The study will take place at New York University Langone Medical Center - Hospital for Joint Diseases which will include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal Care.


Eligibility criteria: Inclusion Criteria:

Study Subjects

* Age between 18 and 80 years
* Indicated for elective cervical spine surgery (including ACDF \[single or multilevel\], posterior cervical laminectomy and fusion, posterior cervical laminoplasty, posterior cervical foraminotomy, cervical disc replacement) after failing at least 6 weeks of non-operative treatment modalities
* Valid driving license
* Regular use of a vehicle
* Signed consent form

Inclusion Criteria

Control Subjects:

* Age between 18 and 80 years
* No pre-existing or recent injuries to neck, torso, back
* No neurologic or systemic debilitating conditions
* Valid driving license
* Regular use of a vehicle
* Signed consent form

Exclusion Criteria:

* Significant visual impairment
* Significant debilitating neurological condition with loss of function of one or more extremities
* Recent extremity surgery
* Recent eye surgery
* Previous history of motion sickness, vertigo in simulated settings
* Recent history of chemical or narcotic dependency involved in active litigation related to their spine problem a the time of screening.
* Involved in workers compensation related to their spine problem at the time of screening

Primary outcomes:
measure: Change in Number of Total Collisions (TC)
timeFrame: Baseline, 3 months
measure: Change in Number of Centerline Crossings (CC)
timeFrame: Baseline, 3 months
measure: Change in Number of Off-road Excursions (ORE)
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Yong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567223: Effectiveness of WBV Versus RAS on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
Official title: Effectiveness of Whole-Body Vibration Versus Rhythmic Auditory Stimulation on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.

Detailed description: The study measured spasticity using the Modified Ashworth Scale (MAS), balance with the Berg Balance Scale (BBS), and lower limb motor function through the Fugl-Meyer Assessment (FMA). Results indicated that both WBV and RAS significantly improved spasticity, balance, and lower limb motor function.

Eligibility criteria: Inclusion Criteria:

* Participant with Age from 40 to 60 years
* Both males and females
* Diagnosed CVA patients
* Chronic stage (after 6 months of onset
* Individuals with BBS score ≥ 20 ≤ 40
* FMI score up to 3(moderate assistance)
* Able to understand command
* Mini-Mental State Examination (MMSE) score of over 20

Exclusion Criteria:

* Systematic Disorder e.g. Rheumatoid arthritis
* Unstable Angina
* Coexisting physical impairments e.g. limb amputation
* Any previous history of neurological disease other than stroke e.g. Parkinson's
* Any previous history of fractures
* Hearing or perception deficits
* Individuals unable to adhere to the study protocol or attend scheduled follow-up visits.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 12 Months
measure: Berg balance scale
timeFrame: 12 months
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
city: Lahore
country: Pakistan
facility: Sehat Medical Complex, Hanjerwal
state: Punjab
Study officials:
References:
Clinical trial NCT03127423: Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
Official title: Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Hybrid ablation
Thoracoscope
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2017-04-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Detailed description: This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one anti-arrhythmic drugs
* Persistent AF lasting more than 1 year or with a left atrial diameter\>50mm

Exclusion Criteria:

* Previous percutaneous catheter ablation or surgical ablation
* Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
* Left atrial diameter\>60mm
* Previous thoracic or lung operation
* Left atrial thrombosis or left atrial appendage thrombosis
* Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)\<70%、FEV1\<50% anticipated value)
* Bilateral carotid artery stenosis\>80%
* Refuse to participate in this study

Primary outcomes:
measure: Survival rate without any recurrence of AF
timeFrame: At 12-month after intervention
Secondary outcomes:
measure: Burden of AF
timeFrame: At 12-month after intervention
measure: Quality of life score
timeFrame: preoperative and 12-month after intervention
measure: Adverse events
timeFrame: 12 months follow up
measure: Left atrial function
timeFrame: preoperative and postoperative
measure: postoperative complications
timeFrame: 30 days after operation
measure: Survival rate without any recurrence of atrial tachyarrhythmia
timeFrame: At 12-month after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02447523: The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Anesthesia
Perioperative Outcome
Complications
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population: Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.

Group sample sizes of 42 in group one and 42 in group two achieve 90% power to detect a difference between the group proportions of 0,2500. The proportion in group one (MetS group) is assumed to be 0,0500 under the null hypothesis and 0,3000 under the alternative hypothesis. The proportion in group two (the Non-MetS group) is 0,0500. The test statistic used is the two-sided Likelihood Ratio test. The significance level of the test was targeted at 0,0500. The significance level actually achieved by this design is 0,0909.

Brief summary: Worldwide, the rising incidence of obesity has led to the identification of an obesity related syndrome, called metabolic. This syndrome is characterized by central obesity, hypertension, insulin resistance and altered lipid levels.

Taking into consideration the rising incidence of obesity, anesthetists will more frequently encounter patients with metabolic syndrome, in their everyday practice. Moreover, the comorbidities that are related to the metabolic syndrome, increase the risk for perioperative complications. Therefore, strategies that will evaluate and modify the risk will be of great importance in the management of these patients, in order to maximize peri-anaesthetic and surgical safety.

The aim of the study is to assess the incidence of metabolic syndrome and the impact of its presence on the outcome of patients undergoing elective laparotomy.


Eligibility criteria: Inclusion Criteria:

* Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia.

Exclusion Criteria:

* Endstage neoplasia
* Procedures performed within 1 hour of admission
* Emergency cases

Primary outcomes:
measure: Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
timeFrame: 2 Weeks
measure: Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
timeFrame: 2 Weeks
measure: Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines
timeFrame: 2 Weeks
measure: Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines.
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00649623: Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute Ltd.
name: James D Carlson, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434223: Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
Official title: Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spondylolisthesis
Spinal Stenosis
Degenerative Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 3
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System

Brief summary: Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Detailed description: To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' elderly patients (aged ≥ 60 years) who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation.

Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the Implanet Jazz System
* Patients at least 60 years of age.

Exclusion Criteria:

* Patients under the age of 60 years old are excluded.

Primary outcomes:
measure: Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: H. Francis Farhadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277623: Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant
Official title: Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Liver Transplant Disorder
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (Therefore, attenuating the syndrome during anesthesia is of great importance.


Eligibility criteria: Inclusion Criteria:

* patients with end-stage liver disease who will undergo living donor transplantation.

Exclusion Criteria:

* Patients with a history of portopulmonary hypertension.
* Hepatopulmonary syndrome.
* Cirrhotic cardiomyopathy.
* Hepatorenal syndrome types 1 and 2.

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: one hour after reperfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Medicine Ain Shams University
Study officials:
References: