louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02075346: Bedside Respiratory Patient Monitoring System - Sensor Off Study
Official title: Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Patient safety monitors
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 20 subjects recruited from the Clinical Laboratory subject data base.

Brief summary: Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.

Detailed description: The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.

The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects 18 years or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors.
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor.
* Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Primary outcomes:
measure: To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time.
timeFrame: The planned duration of the study is 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Clinical Laboratory
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Scott Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905969: Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy
Official title: Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Gastric caner, adjuvant chemotherapy
Lead sponsor: Iwate Medical University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective study. Data analyses are based on archived record and materials of gastric cancer patients whose treatment was curative surgery followed by adjuvant chemotherapy with S-1.

Brief summary: Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has improved disease free time and survival. However, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. In an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by immunohistochemical validation. In the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed gastric cancer.
* Operated before November 2009.
* Stage Ib/II(except for T1, T3N0)/III.
* Received postoperative (R0) adjuvant chemotherapy (S-1).
* Not received postoperative (R0) adjuvant chemotherapy (surgery alone).
* Signed informed consent to provide paraffin embedded tissue of removed specimens.

Exclusion Criteria:

* With advanced neoplastic lesions other than gastric cancer.
* Paraffin embedded tissue is not available.
* Unknown S-1 treatment condition.

Primary outcomes:
measure: Relapse free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Morioka
country: Japan
facility: Iwate Medical University School of Medicine
state: Iwate
Study officials:
References:
citation: Ishida K, Nishizuka SS, Chiba T, Ikeda M, Kume K, Endo F, Katagiri H, Matsuo T, Noda H, Iwaya T, Yamada N, Fujiwara H, Takahashi M, Itabashi T, Uesugi N, Maesawa C, Tamura G, Sugai T, Otsuka K, Koeda K, Wakabayashi G. Molecular marker identification for relapse prediction in 5-FU-based adjuvant chemotherapy in gastric and colorectal cancers. PLoS One. 2012;7(8):e43236. doi: 10.1371/journal.pone.0043236. Epub 2012 Aug 14.
Clinical trial NCT00273169: Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery
Official title: Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Detailed Population Description: The study population will include those patients that have undergone surgery under general anesthesia at St. Marys Hospital, Mayo Clinic Rochester, admitted to the 7MB D/E Intensive Care Unit and require intubation and mechanical ventilation for a period of at least 4 hours after admission

Brief summary: Evaluate correlation between the values from the PSA monitor and clinical assessment of sedation with the RASS on postoperative patients.

Detailed description: Assessing level of sedation in critically ill patients is an integral part of intensive care practice. Sedation scales, such as the Richmond Agitation-Sedation Score (RASS) 1, have been developed, but are imperfect in a general population and of limited use when muscle relaxants are administered. Instruments have been developed to examine cerebral electrical activity using processed EEG in an attempt to determine state of awareness.2 The Bispectral Index (BIS) is a statistically derived measure of cerebral electrical activity to assess cortical-subcortical interaction. The BIS was determined by repeated studies on patients anesthetized in the operating room (OR) with the assumption that sedation is associated with a lack of awareness and recall.2 The Patient State Analyzer (PSA 4000) is a 4-channel processed EEG reading using an advanced algorithm that interprets changes in regional brain activity providing a numerical assessment (ranging from 0-100; 0 = no central nervous system \[CNS\] activity, 100 = awake) to assess the degree of sedation. The PSA 4000 (PSA) is an advancement over the BIS monitor as the BIS is a single channel whereas the PSA is a 4-channel monitor. Additionally, the PSA monitor has new proprietary software for analysis of the EEG data. The PSA is relatively new and thus there is little published data to evaluate its use in the operating room (OR) or the intensive care unit (ICU).

Eligibility criteria: Detailed Population Description: The study population will include those patients that have undergone surgery under general anesthesia at St. Marys Hospital, Mayo Clinic Rochester, admitted to the 7MB D/E Intensive Care Unit and require intubation and mechanical ventilation for a period of at least 4 hours after admission

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Francis X. Whalen, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792669: Psychological Assessment and Skills Training by Simulation in Neurosurgery
Official title: Psychological Assessment and Skills Training by Simulation in Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 300 Students of University of Milan School of Medicine
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2025-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The subject of Safety in Health is assuming in time a predominant position with those of high social, economic and political relevance. Numerous medical-surgical procedures are frequently learned as they are performed directly on the patient. The scope of our research, hence, is to recruit 5th- and 6th-year students of Medicine of the University of Milan who will have the opportunity to use two state-of-the-art 3-D virtual reality neurosurgical simulators at the Besta NeuroSim Center. Psychological Evaluation instruments will be used in order to select the personality profile most fit for a career in neurosurgery and to understand what training method is the most appropriate to achieve the best results in neurosurgery.


Eligibility criteria: Inclusion Criteria:

* 5th - 6th year medical students.
* Signed informed consent.

Exclusion Criteria:

• Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).

Primary outcomes:
measure: Simulation training
timeFrame: 4 weeks
Secondary outcomes:
measure: Psychological assessment
timeFrame: 4 weeks
measure: Spatial assessment
timeFrame: 4 weeks
measure: Career path
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto neurologico Carlo Besta
Study officials:
affiliation: Fondazione Irccs Istituto Neurologico Carlo Besta
name: Francesco DiMeco, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00984269: Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection
Official title: Lymphedema Following Elective Hand and Wrist Surgery in Women Who Are Post Axillary Lymph Node Dissection: A Prospective, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphedema
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.


Eligibility criteria: Inclusion Criteria:

* Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.
* Patients ages 18 and over
* Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of \< 20 minutes.
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.

Exclusion Criteria:

* Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment
* Patients under the age of 18
* Patients who are pregnant
* Patients presenting for an elective hand procedure with an anticipated tourniquet time of \> 20 minutes.
* Patients who are on a blood thinner which cannot be stopped prior to surgery
* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.

Primary outcomes:
measure: Lymphedema 15% change from pre-post in girth
timeFrame: Preoperative,10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Secondary outcomes:
measure: Wound assessment,Patient Satisfaction (on a scale of 0-10,Surgical and postoperative complications
timeFrame: 10-14 days, 6 weeks, 3 months, 6 months, and 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
Study officials:
References:
Clinical trial NCT02073669: Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
Official title: Better Identification of Latent Tuberculosis Infection Among Israeli Young Adults by Comparison Skin Tests and Interferon Gamma Releasing Assays (IGRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis
Keywords: latent tuberculosis
tuberculin skin test
Interferon gamma release assay
immigration
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv Lung Association
First posted: 2014-02-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.


Eligibility criteria: Inclusion Criteria:

* Age 18-25
* Men and women
* Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).
* Native Israelis without a family member who was born in a country with high incidence of tuberculosis.

Exclusion Criteria:

* Prior contact with a tuberculosis patient
* Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.
* HIV infection and any immunodeficiency condition.
* Recent live-virus vaccination
* Acute infectious disease
* Prior serious reaction to tuberculin skin test
* Pregnancy

Primary outcomes:
measure: Interferon gamma release assay ( IGRA)
timeFrame: Up to 3 months after tuberculin skin test
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Ramat-Gan
country: Israel
facility: Israeli Defense Forces
Study officials:
References:
Clinical trial NCT03034369: Caring for the Whole Person
Official title: Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Behavioral Health
Keywords: Integration
Primary Care
Behavioral Health
Health Care Reform
Medical Home
Accountable Care Organization
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Oregon Health and Science University
name: Cascadia Addiction Research and Education, LLC
name: Umpqua Community Health Center
name: Mosaic Medical
name: North Portland Clinic
name: Providence Medical Group
name: Rockwood Clinic
name: The Bend Clinic
name: Yamhill CCO
name: The Annex
name: Cascadia Gardiner Clinic
name: Umpqua Expanded Care Clinic
name: Bridges Clinic
First posted: 2017-01-27
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients accessing care at safety net clinic in Oregon.

Brief summary: The goal of this study is to identify outcomes associated with Behavioral Health Integration (BHI) that matter to patients, to compare changes in outcome over time to measure the impact of different BHI models on different patients, and to create and maintain an Integration Learning Collaborative.

Detailed description: Twelve safety net clinics have been selected to be a part of this study. The clinics vary on a BHI continuum level, which includes minimal collaboration, basic collaboration at a distance, basic collaboration on site, close collaboration (partially integrated) and close collaboration (fully integrated).

Twelve-thousand patients will be randomly selected from the 12 clinics to be invited to participate in the study. Patients who elect to participate will complete a survey at baseline to collect patient-reported outcomes and again twelve months later.

The Oregon All Providers All Claims (APAC) database will be accessed to analyze financial data regarding the patients at baseline and 12 months.

The hypothesis is that the degree of clinic BHI will predict patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Received care at a safety net care clinic in Oregon

Exclusion Criteria:

-

Primary outcomes:
measure: Change in patient reported outcomes
timeFrame: 12 months
measure: Change in health care claims
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Outcomes Research and Education, Providence Health & Services
state: Oregon
Study officials:
affiliation: Director, Center for Outcomes Evaluate and Education, Providence Health & Services
name: Bill J. Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936269: Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure
Official title: Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure (YC-PEM) in Young Children With Typical Development and Neurodevelopmental Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development Disorder
Activity, Motor
Keywords: Cerebral palsy
Activity
Participaiton
Environment
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with typical development and children with neurodevelopmental disabilities (Cerebral palsy, obstetric brachial plexus palsy, autism spectrum disorders or developmental coordination disorders etc.)

Brief summary: The Young Children's Participation and Environment Measure (YC-PEM) is a parent/caregiver reported outcome measure that evaluates the participation status and environmental factors of children under five years old. The aim of this study is to translate the Young Children's Participation and Environment Measure (YC-PEM) into the Turkish language and to investigate the psychometric properties of the Turkish version of YC-PEM in children with typical development and neurodevelopmental disabilities under five years old.

Detailed description: Cross-cultural adaptation Rest-retest reliability Discriminant validity Concurrent validity

Eligibility criteria: Inclusion Criteria:

* children under five years
* children with neurodevelopmental disabilities

Exclusion Criteria:

* parents who refused to participate in the study

Primary outcomes:
measure: Young children's participation and environment measure (YC- PEM)
timeFrame: two years
Secondary outcomes:
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: two years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhıye
Study officials:
affiliation: Dr.Pt
name: Kübra S Bıyık
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213069: Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France
Official title: Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tissue and Organ Procurement
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 1859
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: Health care personnel in South-Mediterranean France

Brief summary: The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.


Eligibility criteria: Inclusion Criteria:

* paramedical or medical care personnel from a participating center
* participates in organ donor activities
* works in a department with organ donor activity

Exclusion Criteria:

* personnel with no contact with organ donor activities
* personnel from non-participating centers
* refuses to participate

Primary outcomes:
measure: VAS Negative/positive feeling
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Montpellier Cedex 05
country: France
facility: Hôpital Guy de Chauliac, CHU de Montpellier
city: Nice
country: France
facility: Hôpital Cimiez, CHU de Nice
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Caroline Boutin, MD
role: PRINCIPAL_INVESTIGATOR
References: