louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04905095: CSAPG Early Warning Score
Official title: CSAPG Early Warning Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undefined
Keywords: Hospital Stay
Mortality
Clinical Deterioration
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 15998
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Early Warning Score (EWS) has been shown in previous studies to be correlated with mortality and mean hospital stay, but it is unknown whether the implementation of the scale improves mortality and mean hospital stay.

This trial aims to study whether the implantation of the EWS in a regional hospital reduces the mean hospital stay (primary objective), mortality and complications (secondary objectives).

For this, an open clinical trial will be carried out in which the hospitalization floors of the hospital will be administratively divided into two sections (two study branches); the EWS scale will be implemented in the computer equipment of one of the sections of each floor, acting the another section as a control branch.

All the patients admitted to the participating hospital floors during one year will be included in the study. The mean stay, mortality and complications will be compared between study branches.


Eligibility criteria: Inclusion Criteria:

* Patients admitted during study period to the participant hospital units.

Exclusion Criteria:

* None

Primary outcomes:
measure: Hospital stay
timeFrame: from baseline to hospital discharge, as much 3 months
Secondary outcomes:
measure: Mortality
timeFrame: from baseline to hospital discharge, as much 3 months
measure: Complications
timeFrame: from baseline to hospital discharge, as much 3 months
Other outcomes:
Locations:
city: Vilafranca Del Penedès
country: Spain
facility: Consorci Sanitari de l'Alt Penedès i Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Cristina Ramos, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771195: Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis
Official title: Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anxiety
Depression
Loneliness
Stress
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-02-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.

Detailed description: The proposed work will consist of four key components. The investigators will collect data from the class of 2023 in each of their remaining years at college, producing (i) longitudinal data that will allow them to probe the long-term mental health effects of connections made during the transition to college, as well as mental health issues and resilience in the wake of the COVID-19 pandemic as a function of social connectedness. The investigators will leverage this rich dataset to build (ii) prospective quantitative models to predict mental health outcomes later in college based on a range of social factors measured early in college. They will further collect (iii) a longitudinal replication cohort, the class of 2024, allowing to establish the robustness of their initial findings across samples. Finally, the investigators will add (iv) a neuroimaging component to this dataset in a subset of the class of 2024. This will allow them to examine brain "markers" of connectedness, and add them to a prospective model, providing a novel integration across brain, behavior, and community levels of analysis, and a synthetic assessment of social factors in long-term mental health.

Eligibility criteria: Inclusion Criteria: Stanford undergraduate students in the classes of 2023 and 2024, as well as all students who reside in their dorms.

-

Exclusion Criteria: People under the age of 18

-

Primary outcomes:
measure: Depression
timeFrame: September 2021 - May 2024
measure: Anxiety
timeFrame: September 2021 - May 2024
Secondary outcomes:
measure: Loneliness
timeFrame: September 2021 - May 2024
measure: Stress
timeFrame: September 2021 - May 2024
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jamil Zaki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236495: Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia
Official title: Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Solitary Mass
Lung Diseases
Keywords: thoracotomy
postoperative pain
spinal morphine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.

Detailed description: Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 year and \< 70 year
* Patient ASA physical status I-III.
* Scheduled for thoracotomy with lobectomy.
* Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

* Known hypersensitivity to morphine or pethidine
* History of bleeding tendency.
* Known case of infection at the back
* Patient refuse for spinal anesthesia
* History of cerebrovascular disease.
* Scheduled for video-assisted thoracoscopic lobectomy.
* Need mechanical ventilatory support during postoperative period

Primary outcomes:
measure: pethidine requirement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
Study officials:
affiliation: Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital
name: Sirilak Suksompong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452695: Acceptability of Telehealth Triage Using Robotic Systems in COVID-19
Official title: Acceptability of Telehealth Triage Using Robotic Systems in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Telemedicine
Robotics
Emergencies
Emerging Infectious Disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department patients

Brief summary: The overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.


Eligibility criteria: Inclusion Criteria:

* Presenting to the emergency department for evaluation
* \> 18 years old

Exclusion Criteria:

* Brought to emergency department via ambulance
* \<18 years old
* non-english speaking
* in extremis, or unable to participate due to underlying acute medical condition

Primary outcomes:
measure: Acceptance of robotic telehealth system
timeFrame: Immediately after completion of triage
measure: Willingness to interact with robotic telehealth system
timeFrame: Immediately after completion of triage
measure: Satisfaction of interacting with a robotic telehealth system
timeFrame: Immediately after completion of triage
Secondary outcomes:
measure: Use of robotic system versus in-person triage
timeFrame: Immediately after completion of triage
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Chai PR, Dadabhoy FZ, Huang HW, Chu JN, Feng A, Le HM, Collins J, da Silva M, Raibert M, Hur C, Boyer EW, Traverso G. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Netw Open. 2021 Mar 1;4(3):e210667. doi: 10.1001/jamanetworkopen.2021.0667.
citation: Huang HW, Chen J, Chai PR, Ehmke C, Rupp P, Dadabhoy FZ, Feng A, Li C, Thomas AJ, da Silva M, Boyer EW, Traverso G. Mobile Robotic Platform for Contactless Vital Sign Monitoring. Cyborg Bionic Syst. 2022;2022:9780497. doi: 10.34133/2022/9780497. Epub 2022 Apr 30.
Clinical trial NCT01105195: Efficacy of Surgical Preparations in Lumbar Spine Surgery
Official title: Efficacy of Surgical Preparations in Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: DuraPrep
ChloraPrep
Lumbar Spine
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2010-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).


Eligibility criteria: Inclusion Criteria:

* All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).

Exclusion Criteria:

* Open wound at the incision site,
* Abrasion in the vicinity of the incision site,
* An active infection at or near the surgical site, or
* An active infection elsewhere in the body.

Primary outcomes:
measure: Positive culture results
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
citation: Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
citation: Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
Clinical trial NCT00617695: Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study With Single-blind, Placebo-challenge Evaluating the Efficacy of Zolmitriptan (Zomig) Nasal Spray 5mg, in the Treatment of Acute Migraine Headache in Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Zolmitriptan
ZOMIG
migraine
headache response
headache
headache pain
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 247
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
* An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
* A history of usual migraine duration of \>2-hours untreated for the 3 month prior to screening

Exclusion Criteria:

* A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
* Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
* Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has uncontrolled hypertension

Primary outcomes:
measure: Headache response and pain-free response to treatment
timeFrame: 15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment
Secondary outcomes:
measure: Adverse Event reports
timeFrame: Four times within 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01748695: A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study Evaluating the Safety, Tolerability and Efficacy of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain Due to Spinal Cord Injury
Keywords: Neuropathic pain
Spinal cord injury
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Vernalis (R&D) Ltd
First posted: 2012-12-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* aged 18 - 65 years
* documented spinal cord injury at or below T5
* moderate pain at or below the level of the spinal cord injury for at least 3 months
* compliant with daily diary
* stable pain scores on the NRS
* mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS score is \>9, the mean Gracely score must be ≤19)

Exclusion Criteria:

* women of child-bearing potential
* men who intend to father a child
* a history of multiple drug allergies, hypersensitivity to any cannabinoid
* an increased risk of seizure
* evidence of depression and/or a score of \>19 on the BDI-II
* suicidal ideation or suicidal behavior in the past 10 years
* a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
* a positive urine test for cannabis at screening
* taking excluded medications that cannot be stopped
* a positive pregnancy test

Primary outcomes:
measure: Mean Pain Intensity (NRS)
timeFrame: 4 Weeks
measure: Safety and Tolerability of V158866 Compared to Placebo
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Translational Pain Research, Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christine N Sang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02325895: Dried Plums for Bone Health in Older Postmenopausal Women
Official title: Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Diseases, Metabolic
Keywords: Osteoporosis
Dried plum
functional food
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2014-12-25
Enrollment: 48
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.

Detailed description: Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates

Eligibility criteria: Inclusion Criteria:

* BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
* Age 65 to 79

Exclusion Criteria:

* BMD t-score at any site fell below 2.5 standard deviation of the mean
* Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
* Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
* Regularly consumed dried plum or prune juice were not included in the study.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 6 months
Secondary outcomes:
measure: Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months
timeFrame: baseline, 3 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: San Diego State Univeristy
name: Shirin Hooshmand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooshmand S, Kern M, Metti D, Shamloufard P, Chai SC, Johnson SA, Payton ME, Arjmandi BH. The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Osteoporos Int. 2016 Jul;27(7):2271-2279. doi: 10.1007/s00198-016-3524-8. Epub 2016 Feb 22.
Clinical trial NCT03066895: BGS Neonatal Pilot Study
Official title: Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain From Heel Sticks
Lead sponsor: Actuated Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Milton S. Hershey Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institutes of Health (NIH)
First posted: 2017-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Medically stable late preterm/term neonates with a gestational age at birth of \> 35 weeks gestation at birth
* Sex: male or female

Exclusion Criteria:

* Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
* Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
* Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
* Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
* Critical illness in the mother preventing the ability to obtain informed consent from parents

Primary outcomes:
measure: Adverse events
timeFrame: Up to 8 days
Secondary outcomes:
measure: Pain Response
timeFrame: 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Actuated Medical, Inc.
name: Ryan Clement, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University College of Medicine
name: Kim Doheny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: