louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05476250: Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
Official title: Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.


Eligibility criteria: Inclusion Criteria:

* The subject is 18 to 80 years of age.
* Subject can read and communicate in English.
* Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.

Exclusion Criteria:

* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Primary outcomes:
measure: Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT02027350: New Methods to Diagnose Constrictive Pericarditis
Official title: Pressure-Volume Analysis of Constrictive Pericarditis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Constrictive Pericarditis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.


Eligibility criteria: Subjects referred for right and left heart catheterization will be eligible.

Primary outcomes:
measure: Presence of constrictive pericarditis
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852850: In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis
Official title: In Vivo Molecular Imaging With Infliximab Antibody With FITC Predicts Therapeutic Response in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active ulcerative colitis will receive infliximab antibody therapy.

Brief summary: Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic responses to infliximab antibody and can be used for personalized medicine in ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Patients with active ulcerative colitis will receive infliximab antibody therapy.

Exclusion Criteria:

* Patients with impaired blood clotting.
* Patients with short bowel syndrome.
* Patients during the pregnancy and lactation period.
* Patients received enema therapy within 1 month before inclusion in the study, or had anti-TNF therapy within the last 12 months.
* Patients participated in another clinical trial or administrated other investigational drugs within 4 months prior to the screening visit.
* Patients with moderate to severe heart failure, active tuberculosis or acute infections.

Primary outcomes:
measure: The number of specific fluorescence signal of mTNF+ cells in patients with UC
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, MD,PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01797250: Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
Official title: Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects With an Existing Intra-arterial Line
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include male and female pediatric and neonatal patients who meet the specified sensor weight requirements with an existing intra-arterial line, typically found in hospital intensive care areas. Subjects of all racial and ethnic backgrounds may be included in the studies.

Brief summary: To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population


Eligibility criteria: Inclusion Criteria:

1. Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
2. Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
3. Subject satisfies a specified sensor requirement (see Table 1).
4. Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
5. Subject is able to accommodate multiple sensors.
6. Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.

Exclusion Criteria:

1. Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded.
2. Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
3. Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
4. Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
5. Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing

Primary outcomes:
measure: SpO2 Accuracy (percentage of blood oxygen saturation)
timeFrame: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital- Los Angeles
state: California
city: Orem
country: United States
facility: Wasatch Neonatal
state: Utah
Study officials:
References:
Clinical trial NCT06596850: Wheelchair Skills Training for People with ARSACS and DM1
Official title: Efficacy of Wheelchair Skills Training to Improve Mobility for People with ARSACS and DM1
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wheelchair Mobility
Manual Wheelchair Skills Training
ARSACS
Myotonic Dystrophy Type 1
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Wheelchairs (WC) are often provided to people with ARSACS and MD1 when they are not able to walk anymore. However, giving someone a MWC alone does not guarantee they will use it safely or properly. Many people who use WC need help from others to get around and they can not always do the things they like to do. This can lead to isolation, stress, and reduced quality of life. In addition, poor use of a MWC could lead to accidents and injuries. Our team recently showed that people with ARSACS have lower MWC skills than other adults who use MWC, and that teaching MWC skills to people with ARSACS seems to work. Now we are ready to test the program with more people with ARSACS and MD1 to see how it can improve MWC mobility and confidence. We also want to hear about people's expectations and experiences with MWC training. People who take part in research will answer questions before and after WC training, and we will follow up with them 3 months later to ask again about their WC use.

This projects directly adresses the mobility needs of people with ARSACS and MD1 who use MWC. Our results may improve how therapists provide training for MWC use, which may improve mobility, participation, and quality of life for people with ARSACS and MD1. Learning just one MWC skill could be life-changing. It could mean the difference between leaving the house or not, which could impact the ability to shop for groceries, see friends, or to have a job.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age, have a diagnosis of ARSACS or DM1, and use a manual WC for mobility (≥3 times/week for ≥8 hours/week).

Exclusion Criteria:

* anticipate a health condition or procedure that contraindicates training (e.g., surgery); or concurrently or planning to receive WC training during the study.

Primary outcomes:
measure: Wheelchair Skills Test Questionnaire (WST-Q)
timeFrame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Secondary outcomes:
measure: Wheelchair Skills Test (WST)
timeFrame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
measure: Wheelchair Use Confidence Scale (WheelCon)
timeFrame: Baseline (T1); immediately post intervention up to 5 weeks after baseline (T2); 3-months follow-up (T3)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Study officials:
References:
Clinical trial NCT01143350: Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

* Primary efficacy criteria: Apathy Inventory clinician score changes
* Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes


Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years
* A diagnosis of dementia according to the ICD 10 criteria
* MMSE score ≤ 24
* Presenting the diagnostic criteria of apathy (cf page ??)
* An Apathy Inventory clinician total score \>3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)

Exclusion Criteria:

* Patients more than 65 years
* MMSE score \> 24

Primary outcomes:
measure: Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
timeFrame: 1 year
Secondary outcomes:
measure: Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: Robert
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
name: Philippe Ph ROBERT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423950: Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)
Official title: Feasibility of Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Pediatric Cancer Foundation
First posted: 2024-05-21
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are patients at participating pedsETB sites.

Brief summary: To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.


Eligibility criteria: Inclusion Criteria:

* Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.

The site investigator will make this determination based on their experience.

* Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
* Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
* Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
* All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.

Primary outcomes:
measure: The feasibility of the pedsETB developing therapeutic strategies
timeFrame: Baseline to up to 60 months from end of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jonathan Metts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490750: Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
Official title: Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Achalasia
Keywords: Heller Dor
Heller Toupet
Myotomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Northwestern University
name: University of Oregon
name: Duke University
First posted: 2007-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.

Detailed description: Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Achalasia

Exclusion Criteria:

* Prior heller myotomy

Primary outcomes:
measure: Primary outcomes are 24 hour pH testing results
timeFrame: pH testing at 6-12 months after surgical treatment
Secondary outcomes:
measure: Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
timeFrame: 6-12 months after surgical intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: L. Michael Brunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558350: Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery
Official title: Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Keywords: lobectomy
inflammatory reaction
intrapulmonary
intrapleural
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution

Brief summary: Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.


Eligibility criteria: Inclusion Criteria:

* elective lobectomy
* elective segmentectomy
* 20-90 years
* informed consent given

Exclusion Criteria:

* emergency operations
* pneumonectomy

Primary outcomes:
measure: Cytokine levels in blood, bronchial lavage fluid and pleural fluid
timeFrame: 2 years
measure: Correlation between cytokine levels and pulmonary morbidity
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265)
timeFrame: 4 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Urs Zingg, MD
role: PRINCIPAL_INVESTIGATOR
References: