louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02607852: Feedback System of PROMS in Children With Burns
Official title: System for Feedback of Patient Reported Outcomes in Children With Burns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: Patient Reported Outcomes Measure
Burns
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 35
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old
Primary purpose: SCREENING

Brief summary: The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.

Detailed description: The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.

The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate

Exclusion Criteria:

* Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.

Primary outcomes:
measure: Responses to Clinician Debriefing Questionnaires
timeFrame: Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Hospitals for Children- Boston
state: Massachusetts
Study officials:
affiliation: Shriners Hospitals for Children
name: Robert L Sheridan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01164852: Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term
Official title: Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 264
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.

The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

Detailed description: Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids

Eligibility criteria: Inclusion Criteria:

* Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation

Exclusion Criteria:

* Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
* Persistent symptoms of preeclampsia
* Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
* Fetal death, restriction of fetal grown

Primary outcomes:
measure: Perinatal death
timeFrame: After begining the randomization until 4 weeks after delivery.
Secondary outcomes:
measure: Perinatal complications and maternal complications
timeFrame: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.
Other outcomes:
Locations:
city: Gauyas
country: Ecuador
facility: Hospital Terodoro Maldonado, del IESS
city: Quito
country: Ecuador
facility: Hospital Carlos Andrade Marin
city: Ciudad Guatemala
country: Guatemala
facility: Hospital de Gineco-Obstetricia del seguro social
city: Toluca
country: Mexico
facility: Hospital de Ginecologia del Instituto Materno Infantil
city: Panamá
country: Panama
facility: Complejo Hospitalario Caja de Seguro Social
city: Panamá
country: Panama
facility: Hospital Santo Tomás
city: Lima
country: Peru
facility: Hospital Nacional Madre Niño, Lima Perú
city: Maracaibo
country: Venezuela
facility: Hospital Nuestra Señora de Chiquinquira
Study officials:
affiliation: Complejo Hospitalario
name: Paulino Vigil-De Gracia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennsylvania Hospital
name: Jack Ludmir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04738552: A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning
Official title: A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Neuro Event Labs Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected motor seizures that are undergoing video-EEG monitoring for routine clinical care.

Brief summary: Increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. The computer vision and machine learning based solution used in this project (Nelli) is an automatic seizure detection and reporting method that has a CE mark for this specific use.

The present study will provide data to expand the utility and detection capability of NELLI and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

Detailed description: This is a prospective, blind comparison to the clinical gold standard for seizure characterization. This study is intended to compare the Nelli Software's ability to identify seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously, Nelli will continuously record audio and video while video-electroencephalography (vEEG) is recorded per typical standard of care. Events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical vEEG data. Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between Epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing video-EEG monitoring for clinical purposes who are suspected of having seizures.

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity of a seizure detection system
timeFrame: During routine seizure monitoring in the hospital - up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Jefferson University
name: Michael Sperling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540852: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Official title: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer receiving chemotherapy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
name: Chao Family Comprehensive Cancer Center
First posted: 2007-10-08
Enrollment: 77
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Detailed description: The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.

Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.

There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Eligibility criteria: Inclusion Criteria:

* Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
* Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy

Exclusion Criteria:

* Female pregnant and age less than 21 years old and have no diagnosis of breast cancer

Primary outcomes:
measure: Diagnostic tool
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute University Of California Irvine
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: David Hsiang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04797052: EEG Detection of Delirium
Official title: Prefrontal EEG Early Detection of Delirium in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Delirium
Keywords: Post operative delirium
Older Adults
Electroencephalography
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: TransMedTech Institute
First posted: 2021-03-15
Enrollment: 234
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational study
Primary purpose: DIAGNOSTIC

Brief summary: VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.

Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.


Eligibility criteria: Inclusion Criteria:

* 65 years and older
* Had a orthopedic or digestive surgery
* Good undersanding of French or English
* Consent to participate in the study

Exclusion Criteria:

* History of seizure or epilepsia
* Structural brain damage
* intelectual deiciency
* Severe major neurocognitive disorder
* incapacity to respond to the questionnaire
* Hospitalised in intensive care or intubated

Primary outcomes:
measure: Difference of relative power of delta and theta brain waves
timeFrame: up to five days after the operation
Secondary outcomes:
measure: Difference of relative power of beta and alpha brain waves
timeFrame: up to five days after the operation
measure: describe the presence of artefacts
timeFrame: up to five days after the operation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT03628352: Taste-masking Study for Tricaprilin in Sensory Panelists
Official title: An Open-Label Taste Assessment of Tricaprilin Formulated as a Powder for Reconstitution in Healthy Panelists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Taste Profile Assessments
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 9
Sex: ALL
Minimum age (years): 25
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 is an open-label multiple-dose study of the taste profile of tricaprilin formulated as a powder for reconstitution.


Eligibility criteria: Inclusion Criteria:

1. The healthy male or female sensory panelist is between 25 and 80 years of age (inclusive) who volunteers for study participation and is able to read, understand, and sign and date a written informed consent form (ICF) before study participation.
2. The panelist is male, or is a non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol, or is a female of non-childbearing potential.
3. The sensory panelist is qualified based on training and experience.
4. The panelist is able to perform the required procedures according to the specified methodology
5. The panelist has provided full written consent to participate in the study.

Exclusion Criteria:

1. The sensory panelist has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the sensory panelist.
2. The sensory panelist has a known sensitivity to medium-chain triglycerides (MCTs) or any of the excipients used in study formulations.
3. The sensory panelist has a known history of kidney disease, inflammatory bowel disease, or Bradycardia. .
4. If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.
5. Panelist must not have any planned hospitalizations or in-patient surgical procedures that are scheduled to take place during the study.

Primary outcomes:
measure: Taste as assessed by trained sensory panelists
timeFrame: 1 day
measure: Smell as assessed by trained sensory panelists
timeFrame: 1 day
measure: Texture as assessed by trained sensory panelists
timeFrame: 1 day
measure: Palatability as assessed by trained sensory panelists
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Senopsys, Inc.
state: Massachusetts
Study officials:
affiliation: Senopsys
name: Carol McKenna
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080152: Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty
Official title: Effect of Walker vs Wheeled Device on Mobility After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient who is using a walker is randomized into two groups:

1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty)
2. 12 patients use a walker 3 months before surgery (knee arthroplasty)

All 24 patients will undergo a total knee Arthroplasty surgery.

Questionnaires at:

0 week from randomization into two groups 6 weeks 12 weeks (surgery) 18 weeks
Primary purpose: SUPPORTIVE_CARE

Brief summary: Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool - A-Linker compared to the standard of care walker.

Detailed description: Patients who are using a walker is randomized into two groups:

1. 12 patients get an A-linker 3 months before surgery (knee arthroplasty)
2. 12 patients use a walker 3 months before surgery (knee arthroplasty)

All 24 patients will undergo a total knee Arthroplasty surgery.

Questionnaires at:

0 week from randomization into two groups 6 weeks 12 weeks (surgery) 18 weeks

Eligibility criteria: Inclusion Criteria:

* Receiving total knee arthroplasty

Exclusion Criteria:

* Not receiving total knee arthroplasty

Primary outcomes:
measure: Mobility after surgery
timeFrame: 6 months
Secondary outcomes:
measure: Questionnaire Results
timeFrame: 6 months
measure: Determining intensity of pain
timeFrame: 6 months
measure: Change in knee society score
timeFrame: 6 months
measure: surgery cancellation
timeFrame: 6 months
measure: Timed up & Go
timeFrame: 6 months
measure: Use of gait aide
timeFrame: 6 months
measure: Time with Device
timeFrame: 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: 450 Broadway
state: California
Study officials:
References:
Clinical trial NCT00647452: Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise
Official title: Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Lipid metabolism
VLDL
Exercise
Lipid metabolism in exercise
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose:

To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the contribution of VLDL-TG in exercise and eventual gender differences


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age: 20-50 years
* Premenopausal

Exclusion Criteria:

* Smoking
* Alcohol abuse
* Use of medications

Primary outcomes:
measure: VLDL-TG turnover
timeFrame: Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology M, Aarhus Hospital
Study officials:
affiliation: Medical Department M
name: Esben Søndergaard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittendorfer B, Horowitz JF, Klein S. Effect of gender on lipid kinetics during endurance exercise of moderate intensity in untrained subjects. Am J Physiol Endocrinol Metab. 2002 Jul;283(1):E58-65. doi: 10.1152/ajpendo.00504.2001.
citation: Gormsen LC, Jensen MD, Nielsen S. Measuring VLDL-triglyceride turnover in humans using ex vivo-prepared VLDL tracer. J Lipid Res. 2006 Jan;47(1):99-106. doi: 10.1194/jlr.M500205-JLR200. Epub 2005 Oct 18.
Clinical trial NCT02197052: iScreen Study: Best Methods for Social Screening in Pediatric Caregivers
Official title: iScreen Study: Best Methods for Social Screening in Pediatric Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disclosure Rates of Social Needs
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: UCSF Benioff Children's Hospital Oakland
First posted: 2014-07-22
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were drawn from adult caregivers seeking treatment for a child in a fast track arm of a large, urban children's hospital emergency department in Oakland, CA (CHO ED Annex).

Brief summary: The goal is to better understand the social needs of a population seeking care in a large, urban children's hospital emergency department with a large Medicaid population. Consenting English and Spanish-speaking adult caregivers will be randomized to social screening via a face -to-face interview with a trained bilingual researcher or via a self-completed tablet-based survey. We hypothesize that there will be no difference in disclosure rates between the two screening formats for items other than highly sensitive items. For highly sensitive items we hypothesize disclosure rates will be higher for the self-completed tablet-based survey.


Eligibility criteria: Inclusion Criteria:

* Caregiver must by age 18 years or older accompanying a child less than 18 years old
* Primary language English or Spanish
* Familiar with the child's household environment

Exclusion Criteria:

-

Primary outcomes:
measure: Disclosure rates for social needs questions
timeFrame: At time point 1, when the subject is first assessed
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura M Gottlieb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottlieb L, Hessler D, Long D, Amaya A, Adler N. A randomized trial on screening for social determinants of health: the iScreen study. Pediatrics. 2014 Dec;134(6):e1611-8. doi: 10.1542/peds.2014-1439. Epub 2014 Nov 3.