louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04493736: CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"
Official title: CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Suicide
Suicidal
Suicide, Attempted
Suicidal Ideation
Depression
Anxiety
Aggression
Trauma, Psychological
Lead sponsor: Clarigent Health
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study employs a cohort design, using open and rolling recruitment of MHP participants at multiple locationssites nationally. We will recruit from mental health therapy practices, schools (using school based MHPs), community mental health agencies, or colleges/universities (counseling centers). Participating MHPs will begin enrolling client participants after completing the online protocol training and brief human subject's protection training. Recruitment will continue on a rolling basis until 2000 client participants have been enrolled and 6000 sessions have been recorded.

Brief summary: Open enrollment study to collect data for the optimization of machine learning models for use in an app for the early detection of mental health and suicidal risk.


Eligibility criteria: Inclusion Criteria:

* Currently a client receiving services from a MHP at a school or outpatient setting, or at a college/university counseling center
* Age ≥ 8 years old
* Able to provide informed consent, parental permission or assent
* English as a primary language

Exclusion Criteria:

* Participants with communication disorders (linguistic or articulation)
* Any minor participants for whom parental or legal guardian consent cannot be obtained.
* Any adult participant for whom Legal Authorized Representative (LAR) consent cannot be obtained.
* History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll them
* Participants with an intellectual and / or neurocognitive disability that the MHP deems a barrier to participation
* Any participant, who at the discretion of the MHP, should not be enrolled

Primary outcomes:
measure: Detection of Mental Health State
timeFrame: 1 year
Secondary outcomes:
measure: Demonstrate the Usability of the platform
timeFrame: 1 year
Other outcomes:
Locations:
city: Mason
country: United States
facility: Clarigent Health
state: Ohio
Study officials:
References:
Clinical trial NCT03980236: Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]
Official title: Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Lead sponsor: Livongo Health
Sponsor class: INDUSTRY
Collaborators: name: Voluntis
name: Evidation Health
First posted: 2019-06-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Lives in the U.S.
* Able to speak, read and write in English
* Diagnosed with type 2 diabetes
* Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
* Takes a daily dose ≤ 0.75 units/kg
* Estimated A1c ≥ 8% (based on existing Livongo data)
* Has been enrolled in Livongo for at least 12 weeks
* Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer)
* Willing to complete study questionnaires
* Willing to complete at-home A1c kits
* Willing to check before breakfast blood glucose at least once per day

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Currently using a long-acting basal insulin analog that is not supported by Insulia
* Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
* Currently pregnant or planning pregnancy

Primary outcomes:
measure: Change in A1c
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Livongo
state: California
Study officials:
affiliation: Livongo Health
name: Bimal Shah, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434836: Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)
Official title: Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Anti-depressant effects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Presbiteriana Mackenzie
name: University Ghent
First posted: 2011-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to train currently major depressed patients on fundamental aspects of working memory while the investigators administer transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training sessions. This working memory training would be performed using adaptive Paced Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory training combined with tDCS or sham placebo (10 sessions) will be measured on different variables, each measured at the start and at the end of the two weeks of training. The investigators expect the greatest anti depressant results and cognitive enhancements in the group of depressed patients that received tDCS combined with working memory training.


Eligibility criteria: Inclusion Criteria:

* Depressive Disorder, Major (SCID)
* HDRS-24 \> 21

Exclusion Criteria:

-Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.

Any axis II disorders.

* Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
* Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 4 weeks
measure: follow-up measure
timeFrame: after two weeks
measure: Internal Shift Task
timeFrame: 2 weeks
measure: Working memory task in combination with pupil dilatation
timeFrame: 2 weeks
measure: Heart Rate Variability
timeFrame: 2 weeks
measure: Salivary Cortisol
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of São Paulo, Hospital Universitário
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Presbiteriana Mackenzie
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Andre R Brunoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunoni AR, Boggio PS, De Raedt R, Bensenor IM, Lotufo PA, Namur V, Valiengo LC, Vanderhasselt MA. Cognitive control therapy and transcranial direct current stimulation for depression: a randomized, double-blinded, controlled trial. J Affect Disord. 2014 Jun;162:43-9. doi: 10.1016/j.jad.2014.03.026. Epub 2014 Mar 27.
Clinical trial NCT01580436: Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Official title: Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Keywords: Tricuspid Valve Insufficiency
Cardiac Valve Annuloplasty
Outcome Assessment (Health Care)
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 300
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: De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but \<2+ TR.


Eligibility criteria: Inclusion Criteria:

* Scheduled for mitral valve surgery
* Tricuspid Annular diameter \> 40mm or \>21mm/m²

Exclusion Criteria:

* Tricuspid Regurgitation more than 2+
* Unable to provide informed consent

Primary outcomes:
measure: combination of all-cause mortality or heart failure hospitalisation
timeFrame: at 12 months post-surgery
Secondary outcomes:
measure: RV function & geometry
timeFrame: 3, 6, 12 and 18 months
measure: Quality of Life
timeFrame: 6, 12 and 18 months
measure: Duration of Hospital and ICU stay
timeFrame: postoperative phase
measure: All-Cause Mortality
timeFrame: at 3, 6, 12 and 18 months post-surgery
measure: Hospitalization for Heart Failure
timeFrame: at 3, 6, 12 and 18 months post-surgery
measure: progressive TR > 2+ post-surgery
timeFrame: 3, 6, 12 and 18 months
measure: cardiovascular mortality
timeFrame: at 3, 6, 12 and 18 months post-surgery
measure: Exercise Tolerance
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (General Hospital Genk)
Study officials:
References:
Clinical trial NCT05770336: STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING
Official title: STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Complication
COVID-19 Pneumonia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Rete cardiologica IRCCS
First posted: 2023-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with previous hospitalization for Covid-19 infection

Brief summary: The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Detailed description: In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase.

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.

Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

Eligibility criteria: Inclusion Criteria:

* Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
* Adult patients between 18 and 90 years of age
* Signature of informed consent

Exclusion Criteria:

* Patient with poor echocardiographic acoustic window impairing the performance of the examination
* Patients with atrial fibrillation
* Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function

Primary outcomes:
measure: Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCSS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Eustachio Agricola, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05138536: CT Change Management in Trauma Patients
Official title: Does Comprehensive CT Change Management in Trauma Patients with No Neurologic Deficits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Neurologic Deficits
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All trauma patients from Methodist Health System.

Brief summary: In high-volume trauma centers, multi-slice CT scanners have become the routine imaging modality for screening trauma patients due to their speed and accuracy. In trauma patients with no known neurologic deficits, diagnostic CT is often obtained though it remains unclear whether this affects management of the patient \[1\]. With the growing cost of health care, a careful look at the benefit and cost of CT is needed to determine how to best utilize this modality in the evaluation of trauma patients.

HYPOTHESIS: In trauma patients with absence of neurologic defects, the addition of comprehensive CT does not change overall clinical management.

Detailed description: Objectives: The primary objective of this study is to determine the benefit of the CT scan in the clinical management or outcomes of the trauma patients with no neurologic deficits.

Primary Outcome: Percentage of trauma patients with no known neurologic deficits who underwent a CT, any clinically impactful CT findings.

Secondary Outcome: Percentage of benefits CT provides in clinical features, clinical outcomes, injury severity score, GCS, age, sex, ethnicity, cause of injury, mechanism of injury, hospital length of stay, operative vs. non-operative, discharge disposition, radilogy, pathology results and images, any additional morbidities, total cost, 30-day readmission rate, and morality. And when operation does occur, the types of operation and the resulting cost and length of stay.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18-years-old
* No localizing neurologic defect
* Any cause or mechanism of injury
* Comprehensive CT obtained

Exclusion Criteria:

• Any patients that are pregnant or breastfeeding

Primary outcomes:
measure: Percentage of trauma patients with no known neurologic deficits who underwent a CT
timeFrame: April 2006 - April 2016
Secondary outcomes:
measure: Percentage of benefits CT provides in clinical features
timeFrame: April 2006 - April 2016
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Joseph Amos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445936: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Official title: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rectum Cancer
Keywords: loop-ileostomy reversal
hernia prevention
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled multicenter trial
Primary purpose: PREVENTION

Brief summary: This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Detailed description: Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.

The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.

Eligibility criteria: Inclusion Criteria:

* Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
* 18 years or older
* Patient has a life expectancy of at least 12 months.
* Patient signs the Informed consent and agrees to attend all study visits

Exclusion Criteria:

* Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
* Patients with concurrent or previous malignant tumors within 5 years before study enrollment
* Patients with T4b tumors which imposed a multi-organ resection
* Patient undergone emergency procedures
* Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with life expectancy of less than 12 months
* Pregnancy or suspected pregnancy

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days
measure: Incisional hernia
timeFrame: 10 months
Secondary outcomes:
measure: Complications classified by Clavien-Dindo classification
timeFrame: 30 days
measure: Re-operation rate
timeFrame: 5 years
measure: Operative time
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Quality of life measured by RAND-36 survey
timeFrame: 5 years
measure: Incidence of hernia
timeFrame: 5 years
measure: Cost analysis
timeFrame: 5 years
Other outcomes:
Locations:
city: Jyvaskyla
country: Finland
facility: Jyvaskyla Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinajoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Elisa Mäkäräinen-Uhlbäck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351036: Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?
Official title: Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypothermia
Perioperative/Postoperative Complications
Hypothermia Following Anesthesia
Keywords: Hypothermia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 0
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: All patients ≥ 18 years undergoing elective surgery

Brief summary: Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning it´s implementation in the clinical routine.

Detailed description: Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events such as impaired coagulation, increased risk for wound infections and patient discomfort among others. The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia published in 2014 concerning it´s implementation in the clinical routine. In a first phase the current status should be recorded. If this reveals an inappropriate high incidence of perioperative hypothermia training arrangements shall be taken for non-physician personnel in the PACU in a 2nd phase of the project. The third phase is intended to evaluate the effect of the training arrangements on the incidence of hypothermia.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years undergoing elective surgery admitted to the PACU

Exclusion Criteria:

* Patients \< 18 years
* Emergency surgery

Primary outcomes:
measure: Incidence of postoperative hypothermia
timeFrame: Immediately after arrival at PACU
Secondary outcomes:
measure: Incidence of intraoperative hypothermia
timeFrame: Duration of surgical procedure
measure: Incidence of preoperative hypothermia
timeFrame: Immediately after arrival at holding area
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
name: Jan Höcker, MD
role: STUDY_DIRECTOR
References:
citation: Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.