louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03751748: Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
Official title: Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Normal Ejection Fraction
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sinai Health System
name: University Health Network, Toronto
First posted: 2018-11-23
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, sham controlled, single blind with objective end points.
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

Detailed description: The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age \> 40 years
* LVEF \> 45% documented within the last 3 months.
* NYHA class ≥II status or 6MWT distance \<80% predicted.
* Left atrial enlargement
* PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.
* Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic monitoring.

Exclusion Criteria:

* Recent MI, PCI or CABG
* Untreated CAD with indication for revascularization
* Recent stroke, pulmonary embolism or major surgery
* Uncontrolled atrial fibrillation
* H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease
* Inability to perform a 6-minute walk test.
* Clinically significant valvular disease
* Uunsuitable for study participation at investigator discretion.
* Severe COPD, Anemia or morbid obesity
* Uncontrolled hypertension
* Women of child bearing age
* RA pressure \>15 mmHg or PVR \>4 wood units

Primary outcomes:
measure: 6MWT
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Congestive heart failure (CHF)
timeFrame: 12 months
measure: Quality of Life (QOL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's hospital
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT03400748: ANET Electrosurgery Applicator Pilot Evaluation Study
Official title: ANET Electrosurgery Applicator Pilot Evaluation Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lung Cancer Metastatic
Keywords: Electrosurgery
RF ablation
Minimally invasive
Lung cancer
Lung metastasis
Lung tumor
Primary
Metastatic
Endobronchial ultrasound
EBUS
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

Detailed description: This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.

Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.

Eligibility criteria: Inclusion Criteria:

1. Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
2. Pathological proof of target nodule/tumor type and malignancy
3. Target nodule/tumor which can be accessed via EBUS bronchoscopy
4. Resection/surgical candidate
5. Participants must be at least 18 years old and able to provide consent

Exclusion criteria:

1. Subjects in whom flexible bronchoscopy is contraindicated
2. Target nodule \< 1.0 cm
3. Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
5. Pacemaker, implantable cardioverter, or other electronic implantable device

Primary outcomes:
measure: ANET Related Peri-procedural Adverse Events
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT06990048: The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
Official title: The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
Collaborators: name: Fivos
First posted: 2025-05-25
Enrollment: 2000
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: Approximately 20,000 patient data will be extracted from approximately 900 sites participating in the VQI EVAR registry in the US. A minimum of 2000 AFX2 System patients will be included.

Brief summary: This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.

Detailed description: Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.

Eligibility criteria: Inclusion Criteria:

* All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study.

Exclusion Criteria:

* Ruptured AAA repair with the AFX2 or comparator device
* Patients with AFX2 in AFX relining, or relined comparator grafts.

Primary outcomes:
measure: Rates of AAA Rupture, Reintervention and Mortality
timeFrame: 5 Years
measure: Incidence of Endoleak
timeFrame: 5 Years
Secondary outcomes:
measure: Long Term Safety
timeFrame: 10 Years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: The Dartmouth Institute
state: New Hampshire
Study officials:
References:
Clinical trial NCT01167348: The Effectiveness Of Auricular Acupressure On Body Weight Parameters On Patients With Schizophrenia
Official title: The Effectiveness Of Auricular Acupressure On Body Weight Parameters On Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Obesity
Keywords: auricular acupressure
obesity
schizophrenia
body weight
Lead sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether auricular acupressure is effective in reducing body weight, waist circumference, or lipid profile.


Eligibility criteria: Inclusion Criteria:

1. ICD:295,living in chronic ward for more than 2 month
2. Body Mass Index (BMI) \>or=24
3. Age between 20 to 60
4. Psychotic status stable and can communicate

Exclusion Criteria:

1. Unstable psychotic status
2. Participants who have endocrine disease
3. Participants who have cardiac disease
4. Participants who have immunological disease
5. Participants who have liver or renal function impairment
6. Pregnant woman or in milking stage
7. Cerebrovascular accident (CVA) stroke and disability
8. Participant who attends weight control programs in recent 3 months
9. Any conditions that clinical doctors refuse to let join in this study

Primary outcomes:
measure: Using Body weight scale (kilogram) and checking body weight for all participants
timeFrame: 2 months
Secondary outcomes:
measure: waist circumference
timeFrame: 2 months
measure: Fat percentage by using bio-Impedance Analysis(Tanita-519 machine)
timeFrame: 2 months
Other outcomes:
Locations:
city: Nan-Tou
country: Taiwan
facility: Tsao-Tun Psychiatric Center
Study officials:
affiliation: Tsaotun Psychiatric Center
name: Ching Han-Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706848: Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
Official title: A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Lead sponsor: Halscion, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the resulting scar consequences following suturing of a wound.


Eligibility criteria: Inclusion Criteria:

* Patients electing to undergo a surgical procedure;
* Patients able and willing to give written informed consent

Exclusion Criteria:

* Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin

Primary outcomes:
measure: Safety
timeFrame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Secondary outcomes:
measure: Effectiveness
timeFrame: Assessed at Months 1, 3, 6, 9 and 12
measure: Device Performance Evaluation
timeFrame: Assessed at Day 1
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Angelius Szpital Proviat
city: Krakow
country: Poland
facility: Oddzial Leczenia Oparzen Chirugil Plastysznej
city: Warsaw
country: Poland
facility: Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
city: Birmingham
country: United Kingdom
facility: The Westbourne Center
city: Brentwood
country: United Kingdom
facility: Brentwood Hospital
city: London
country: United Kingdom
facility: Plastic Surgery W1 Ltd, Suite 1
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Brentwood Hospital
name: Venkat Ramakrishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01895348: A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea is a common disease, associated with cardiovascular disease, cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional evaluation of upper airway and airway obstruction could be possible. The problem of the DISE is that there is the difference between a sedative-induced sleep and normal sleep. Moreover there were no standard sedation protocol of DISE. Propofol has short half-life, about 3 minutes, so the patients could recover quickly from it. In recent years, using target controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot study, the endoscopy for the diagnosis of sleep apnea could be done successfully with propofol TCI. However there were some desaturation events, although the EEG showed that the patient was not in deep sleep enough. Therefore we thought that not only further study of propofol for DISE but also the study of other drugs for DISE will be needed to overcome this limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect and almost no respiratory depression, therefore it could be a good alternative drug for DISE. The purpose of this study is designing the appropriate sedation protocol for DISE using propofol or dexmedetomidine, and enabling the safer and more accurate DISE.


Eligibility criteria: Inclusion Criteria:

* ASA class 1, 2
* Age ≥ 20 yrs
* undergoing drug-induced endoscopy

Exclusion Criteria:

* patient's reject
* patients with hearing impairment or neurological deficits
* patients taking medicine that can affect the central nervous system
* History of adverse drug reactions
* Glasgow coma scale ≤ 15
* could not undergo the endoscopy
* could undergo the endoscopy, but do not undergo UPPP

Primary outcomes:
measure: Desaturation rate
timeFrame: Baseline / 5 min after remifentanil TCI start / 5 min after propofol TCI start or 10 min after dexmedetomidine loading start / every 5 min until surgeon can do endoscopy successfully / immediately after endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03226548: Effect of EITC on Biological Markers of Aging, Health and Mortality
Official title: An Experimental Investigation Into the Impact of Socioeconomic Context on Biological Markers of Aging, Health and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poverty
Tax Policy
Keywords: Earned Income Tax Credit (EITC)
Tax Credit
Paycheck Plus
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: MDRC
name: National Institute on Aging (NIA)
First posted: 2017-07-21
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and longevity effects associated with increasing the Earned Income Tax Credit (EITC). EITC is a national program that provides tax credits to low-income, disproportionately minority workers who file taxes. EITC is politically popular, having received bipartisan support. The EITC, along with state supplemental programs, have 7 million American families out of poverty. The investigators' preliminary data analyses show that the EITC has had large population health impacts, reversing declines in self rated health and survival among the poorest Americans.

Detailed description: Poverty disproportionately impacts minority and rural populations and is very strongly correlated with poor health over the life cycle, and has been hypothesized to lead to a shorter, less healthy aging process. Poverty is associated with a greater burden of disease than smoking and obesity combined and accounts for the bulk of health disparities by race. It is widely believed that an antipoverty policy, such as Earned Income Tax Credit (EITC), could improve healthy aging among working-age low-income adults over the life cycle. It does so by increasing material hardship and psychological stress, two risk factors that are strongly correlated with biological markers of premature aging (e.g., shorter telomeres, higher cholesterol levels, and higher blood pressure).

Eligibility criteria: Inclusion Criteria:

1. a US resident
2. Filed taxes
3. Earned \<$30,000 in the previous year
4. Aged 21-64
5. Have a Social Security number

Exclusion Criteria:

1. Eligible for Supplemental Security Income or Social Security Disability Insurance
2. Married
3. Have dependent children

Primary outcomes:
measure: Mean Score on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4 Years
measure: EuroQol 5D5L
timeFrame: 4 years
Secondary outcomes:
measure: Mean Body Mass Index (BMI)
timeFrame: 2 Years
measure: Telomere length
timeFrame: 4 years
measure: Mortality
timeFrame: 4 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Westat
state: Georgia
Study officials:
affiliation: Columbia University
name: Peter Muennig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06568848: Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
Official title: Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: "Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.

Detailed description: This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

Eligibility criteria: Inclusion Criteria:

* 1. cerebral palsy (CP)
* Severity: Typically applied to those with mild to moderate CP

Exclusion Criteria:

* Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
* Severe cp cases may be excluded

Primary outcomes:
measure: GMFM Scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps
state: Punjab
Study officials:
References:
Clinical trial NCT00945048: Non-Invasive Determination of Cardiac Output by Electrical Velocimetry
Official title: Non-Invasive Determination of Cardiac Output by Electrical Velocimetry Compared With Magnetic Resonance Tomography and Inert Gas Rebreathing Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Diseases
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with indication for CMR

Brief summary: The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). Therefore the aim of the study at hand was to evaluate the electrical velocimetry technique as a new method for determining the CO and to compare this new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance Tomography


Eligibility criteria: Inclusion Criteria:

* Indication for CMR
* Ability of following instructions for electrical velocimetry test, rebreathing test and spirometry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: 1st Department of Medicine, University Hospital Mannheim
state: Baden-Württemberg
Study officials:
affiliation: 1st Department of Medicine
name: Joachim Saur, Dr.
role: STUDY_DIRECTOR
affiliation: 1st Department of Medicine
name: Jens Kaden, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05014048: Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men
Official title: Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infection: a Randomized, Double-blinded and Plasebo Controlled Trial Among Young Finnish Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Respiratory Tract Infections
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Finnish Defense Forces
First posted: 2021-08-20
Enrollment: 231
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men


Eligibility criteria: Inclusion Criteria;

* Male
* 18-29 years of age
* examined as Healthy according to Finnish Military Health Care regulations

Exclusion Criteria

* Female
* age \> 30 yrs

Primary outcomes:
measure: Days off duty due to acute respiratory tract infections
timeFrame: 4 months
Secondary outcomes:
measure: Days off duty due to musculoskeletal disorders
timeFrame: 4 months
measure: Aerobic and muscular fitness
timeFrame: 4 months
Other outcomes:
Locations:
city: Hämeenlinna
country: Finland
facility: Finnish Defence Forces
Study officials:
affiliation: University of Tampere, Finland
name: ilkka laaksi, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: