louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00917514: An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen
Official title: An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen During Azathioprine Treatment in Patients With Crohn's Disease or Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Dosing Tool
Compliance
User Friendly
Crohn's Disease
Ulcerative Colitis
Lead sponsor: Medicpen AB
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chrohn's disease or Ulcerative Colitis. Male or Female above 18 years of age. Ability to provide written informed consent. Must have been on Azathioprine treatment for at least 6 months prior to study start.

Brief summary: This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

Detailed description: The medical device MedicPen will be investigated for it's qualities with regards to medication compliance and user friendliness. The patient group selected here is patients with Crohn's disease that are treated with Azathioprine. The patient selection was made since the metabolite can be easily measured and the compliance can be therefore be followed. The treatment will follow the standard care given to these patients.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years or older
* Provided written informed consent
* Diagnosed with Chron's disease or Ulcerative Colitis
* Treated with Azathiprine for at least 6 months prior to study start

Exclusion Criteria:

* Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.

Primary outcomes:
measure: User friendliness of Dosing Tool MedicPen
timeFrame: June 2009 to Nov 2009
Secondary outcomes:
measure: Measure treatment compliance
timeFrame: June 2009 to Nov 2009
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Department for Gastrointestinal medicin Karolinska University Hospital
Study officials:
affiliation: Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge
name: Mikael Lördal, Cheif MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209014: Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease
Official title: Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: B-Cell Lymphoma
Hodgkin's Disease
Keywords: B-Cell Lymphoma
Hodgkin's Disease
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2005-09-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma.

Detailed description: Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. This research is being done because current treatment does not help everyone with this disease. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma. Thalidomide has been shown to have activity against other cancers but is not approved by the FDA for treatment of lymphoma. Thalidomide prevents growth of new blood vessels that allow cancer cells to receive nourishment and spread. Another reason for doing the study is that researchers want to learn more about how the drug works and whether some patients respond better than others.

Eligibility criteria: Inclusion Criteria:

* Patients with an expected survival period of 6 months or greater and who have been diagnosed with any stage of diffuse large B-cell lymphoma or Hodgkin's disease will be eligible to participate in this study. Final eligibility will be determined by the health professionals conducting this trial.

Exclusion Criteria:

* Women who are pregnant, lactating or who refuse to have a pregnancy test will not be eligible for this study. Also, patients with an active infection, or a history of current or previous deep vein thrombosis and/or currently receiving anticoagulant therapy for deep vein thrombosis will be excluded from participation in this study. Final eligibility will be determined by the health professionals conducting this trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: L. Thompson Heffner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03969914: PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury
Official title: PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Respiration, Artificial
Acute Kidney Injury
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of critically ill patients

Brief summary: The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI


Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU with expected mechanical ventilation \>48h

Exclusion Criteria:

* Ultrasound RRI evaluation non available
* Patients with arrhythmia
* Pregnancy

Primary outcomes:
measure: Occurence of AKI
timeFrame: once a day until day 7
Secondary outcomes:
measure: Change in RRI at different level of PEEP
timeFrame: One a day until day 5
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
city: Siena
country: Italy
facility: Università di Siena
Study officials:
References:
Clinical trial NCT04380714: Changes in the Consumption of Psychoactive Substances During Containment Linked to COVID-19
Official title: Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: People Incarcerated
COVID-19
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People incarcerated in Villeneuve-Lès-Maguelon prison

Brief summary: The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.

On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.

Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.

However,prisoners have a higher prevalence of substance use disorders than the general population.

What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

* Anonymous questionnaire from the start
* Collection of socio-demographic data
* Collection of consumption data before and during containment
* Collection of monitoring data


Eligibility criteria: Inclusion criteria:

* Men incarcerated at Villeneuve Les Maguelone prison
* On a given date (May 12)
* Major
* French speaking
* non illiterate

Exclusion criteria:

* minors
* patients refusing
* non-French speaking
* illiterate

Primary outcomes:
measure: percentage changes in the consumption of psychoactive substances
timeFrame: 1 day
Secondary outcomes:
measure: Assessment of the level of stress
timeFrame: 1 day
measure: Assessment of depression
timeFrame: 1 day
measure: Craving modification evaluation
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Aurélie Mieuset, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580614: Paired tVNS With ERP in OCD
Official title: Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OCD
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: International OCD Foundation
First posted: 2022-10-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.


Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18 and 55
* Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity
* Participants must be willing and able to provide informed consent.

Exclusion Criteria:

* Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects.
* People with an active eating disorder that requires treatment, but we will not exclude people who are in remission.
* Current illicit or prescription drug abuse
* Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded
* No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable

Primary outcomes:
measure: Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
timeFrame: Baseline up to 1 month post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: John Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926114: Is Microlearning the Alternative in the Age of Hyperconnectivity
Official title: Is Microlearning the Alternative in the Age of Hyperconnectivity: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Knowledge Acquisition
Engagements and Motivation
Keywords: Microlearning
Medical Education
Digital Natives
Hyperconnectivity
Spinal deformities
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This Quasi-Experimental Study evaluated whether microlearning a strategy delivering brief, focused learning units enhances knowledge acquisition and retention among fifth-year medical students studying pediatric spinal deformities compared to a traditional block-format module.

Methods: twenty-four students will be included into two groups. The microlearning group will receive sequential daily learning units over ten days, while the traditional group will engage in a comprehensive two-day self-learning module. Pretest, immediate post-test, and one-month post-intervention assessments will be performed using standardized MCQ and SAQ instruments. Learner engagement, time investment, and content clarity were additionally evaluated via structured surveys.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled fifth-year medical students Registered for the optional module in Physical Medicine and Rehabilitation Access to a personal computer, tablet, or smartphone with internet connectivity Ability to access the institutional Modular Object-Oriented Dynamic Learning Environment (Moodle) learning management system (LMS) Voluntary oral informed consent Commitment to complete both pre-assessment and post-assessment evaluations Willingness to participate in either learning modality (microlearning or traditional block-format) as determined by randomization

Exclusion Criteria:

Failure to complete the pretest assessment Non-completion of the pre and post-test assessment Withdrawal of consent at any point during the study Development of circumstances that would render continued participation burdensome to the participant

Primary outcomes:
measure: knowledge acquisition : Short and long-term retention
timeFrame: Immediatly post intervention score and one month post intervention score and the difference between pre and immediate post intervention score
Secondary outcomes:
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: TUN
Study officials:
References:
Clinical trial NCT04814914: An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120
Official title: An Observational Study to Evaluate the Presence of Symptoms After COVID-19 Infection in Patients Who Participated in K031-120 or K032-120 Study ("Long Hauler")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Microbiome
COVID-19
Corona Virus
Corona Virus Disease
Kaleido
Kaleido Biosciences
KB109
Oligosaccharide
Glycan
Microbiome metabolic therapy
MMT
Supportive Self Care
SSC
Telemedicine
K031-120
K032-120
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in K031-120 or K032-120 study.

Brief summary: This observational clinical study aims to evaluate the presence of symptoms of COVID-19 infection in patients who participated in K031-120 or K032-120 ("long hauler").


Eligibility criteria: Inclusion Criteria:

* Have consented to participate over the telephone
* Have been randomized in either the K031-120 or K032-120 study

Exclusion Criteria:

* Have withdrawn consent from K031-120 or K032-120

Primary outcomes:
measure: Proportion of patients with persistent COVID-19 symptoms for at least 12-weeks post-randomization in K031-120 or K032-120 study.
timeFrame: 12-weeks from randomization in K031-120 or K032-120
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: HealthStar Research, LLC
state: Arkansas
city: Chicago
country: United States
facility: Quad Clinical Research
state: Illinois
Study officials:
affiliation: Kaleido Biosciences, Inc.
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01294514: Novel Non-Invasive Monitoring Parameter in Healthy Volunteers
Official title: Novel Cardio-Respiratory Parameter in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No Conditions
Focus is Respiratory Rate
Keywords: Respiratory Rate
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.

Detailed description: Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 or older
* Subject is willing and able to provide written consent

Exclusion Criteria:

* Severe contact allergies to standard adhesive materials
* Subjects with abnormalities that may prevent proper application of the device
* Women who are pregnant or lactating
* Subjects with significant Arrhythmias

Primary outcomes:
measure: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
timeFrame: Participants were monitorerd on average of 30 minute period
Secondary outcomes:
measure: The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
timeFrame: Participants were monitored on average of 30 minute periods
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Covidien- RMS
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Scott Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301014: Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position
Official title: Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Stability
Keywords: accuracy, anterior cruciate ligament, diagnostic value, examination, knee, Lachman test, sensitivity, specificity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 57
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 31 men and 21 women ranging in age from 16-57 years old with complaint of knee pain

Brief summary: This study is investigating the reliability and diagnostic accuracy of a Lachman's test conducted in a prone position to detect the presence of a torn anterior cruciate ligament.


Eligibility criteria: Inclusion Criteria:

* current knee pain complaint in subjects between 15 and 60 years old

Exclusion Criteria:

* the inability to assume the prone testing position
* evidence of a fracture by application of the Ottawa Fracture rule
* previous knee joint arthroplasty
* suspicion of posterior cruciate involvement
* knee surgery in the previous six months
* presence of serious underlying non-mechanical pathology
* systemic illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
citation: Mulligan EP, Harwell JL, Robertson WJ. Reliability and diagnostic accuracy of the Lachman test performed in a prone position. J Orthop Sports Phys Ther. 2011 Oct;41(10):749-57. doi: 10.2519/jospt.2011.3761. Epub 2011 Sep 4.
Clinical trial NCT05082714: Tocilizumab Versus Baricitinib in Patients With Severe COVID-19
Official title: Tocilizumab Versus Baricitinib in Hospitalized Patients With Severe COVID-19: an Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Acute Respiratory Distress Syndrome
PaO2/FiO2
Tocilizumab
Baricitinib
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether baricitinib is non-inferior to tocilizumab in severe COVID-19.

Detailed description: Patients with COVID-19 will be assigned to one of the two arms on 1:1 ratio based on the time point that PaO2/FiO2\<200 will be observed. Patients aged 18 years or older with PaO2/FiO2 \<200 at any time during their hospitalization will be included in the analysis irrespective of values in inflammatory markers, such as CRP and ferritin. Exclusion criteria will be: age\<18 years, pregnancy, glomerular filtration rate\<30 and application of mechanical ventilation prior patients' transfer to our Hospital. Each patient or the patient's legally authorized representative provided written or witnessed oral informed consent.

Day 1 will be considered the first day that PaO2/FiO2\<200 will be identified. Treatment with either tocilizumab or baricitinib will start from day 1. Primary and secondary outcomes will be assessed in the days described below.

This study aims to investigate whether baricitinib is non-inferior to tocilizumab in patients with severe COVID-19. Two hundred fifty one (n=251) patients will be enrolled based on the following assumptions: 1) HR θ 1, 2) HR θο 1.5, 3) overall probability of event (primary end point) 0.6 (based on previous records of our hospital), 4) power 80%, 5) type I error α 5%.

Eligibility criteria: Inclusion Criteria:

- COVID-19, PaO2/FiO2\<200

Exclusion Criteria:

- Age\<18 years, Pregnancy, Glomerular filtration rate\<30, Application of mechanical ventilation prior patients' transfer to our Hospital

Primary outcomes:
measure: Mechanical ventilation or death by day 28
timeFrame: day 28
Secondary outcomes:
measure: Time to discharge over the 28-day period
timeFrame: day 28
measure: World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)]
timeFrame: day 10
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras, Department of Respiratory Medicine
Study officials:
References: