louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04617561: Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
Official title: Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis, Autoimmune
Primary Biliary Cholangitis
Keywords: Glucocorticoid
Ursodeoxycholic Acid
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 90
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: A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-75 years;
2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN \< ALT \< 5xULN or 3xULN \< AST \< 5xULN or 1.3xULN \< IgG \< 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
3. Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of cirrhosis;
3. Patients with presence of fulminant liver failure;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease; Pregnant and breeding women and women of childbearing age in need of reproduction;
5. Severe disorders of other vital organs, such as severe heart failure, cancer;
6. Parenteral administration of blood or blood products within 6 months before screening;
7. Recent treatment with drugs having known liver toxicity;
8. Taken part in other clinic trials within 6 months before enrollment.
9. patients with contraindications of glucocorticoid

Primary outcomes:
measure: Biochemical remission
timeFrame: up to 12 months
Secondary outcomes:
measure: Partial remission
timeFrame: up to 12 months
measure: Minimal response
timeFrame: up to 12 months
measure: Treatment failure
timeFrame: up to 12 months
measure: ALT,AST,IgG
timeFrame: baseline and month 3,6,12
measure: percentage of immune cells
timeFrame: baseline and month 12
measure: Side-effects
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03996161: Effect of Semi-sitting Position on Mask Ventilation
Official title: Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients


Eligibility criteria: Inclusion Criteria:

* Obese patients undergoing general anesthesia

Exclusion Criteria:

* diseases or structural abnormalities in the upper airway
* those who were at risk of aspiration
* cardiovascular or respiratory diseases
* pregnancy

Primary outcomes:
measure: Expiratory tidal volume
timeFrame: 1 minute after the induction of anesthesia
Secondary outcomes:
measure: Minute ventilation during mask ventilation in the supine and semi-sitting positions
timeFrame: 1 minute after anesthesia induction
measure: The incidence of inadequate mask ventilation or dead space ventilation.
timeFrame: during mask ventilation
measure: Peak inspiratory pressure
timeFrame: during mask ventilation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
citation: Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.
Clinical trial NCT06373861: Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)
Official title: Generating Advancements Through Longitudinal Analysis in X and Y Variations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sex Chromosome Aneuploidy
Keywords: X&Y variations
chromosome variations
Klinefelter
XXY
XXX
XYY
tetrasomy
pentasomy
trisomy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2024-04-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this registry is patients diagnosed with sex chromosome aneuploidy (SCA) conditions throughout the lifespan.

Brief summary: GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive.


Eligibility criteria: Inclusion Criteria:

1. Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition
2. Any age
3. Any gender
4. Informed consent for individuals \>18 years of age, parent/guardian permission for individuals \<18 or proxy-consent from legally authorized representative if impaired decision making

Exclusion Criteria:

a. Lack of documentation of genetic testing confirming SCA diagnosis

Primary outcomes:
measure: Health Conditions
timeFrame: From study start until condition observed, up to 15 years
Secondary outcomes:
measure: Prevalence of mental health diagnoses
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of obesity
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of dyslipidemia
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses-prevalence of hypertension
timeFrame: From study start until condition observed, up to 15 years
measure: Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism
timeFrame: From study start until condition observed, up to 15 years
measure: Autoimmune diagnoses - prevalence of diabetes
timeFrame: From study start until condition observed, up to 15 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Shanlee M Davis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196261: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction
Official title: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infarction, Myocardial
Keywords: Assessment, Risk
Autonomic nervous system
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the performance of established and new risk preditors in predicting long term-mortality (up to ten years) of post-infarction patients.


Eligibility criteria: Inclusion Criteria:

acute myocardial infarction

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Georg Schmidt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Petra Barthel, MD
role: STUDY_DIRECTOR
affiliation: Deutsches Herzzentrum Muenchen
name: Axel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.
citation: Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. doi: 10.1161/01.CIR.0000088783.34082.89. Epub 2003 Aug 25.
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.
citation: Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.
Clinical trial NCT06633861: Data Collection Study for RFP (Respiration From Plethysmogram)
Official title: Data Collection Study for RFP (Respiration From Plethysmogram)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: In-patients Assessment of Vital Signs
Keywords: vital signs
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Betsi Cadwaladr University Health Board
First posted: 2024-10-09
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.

Detailed description: In an additional spot-check measurement procedure, the study will measure oxygen saturations through different Philips SpO2 finger sensors. Patients will wear a nasal cannula linked to a CO2 measuring device at the same time. The data from both devices will be used to design and improve algorithms for measurement of respiratory rate with the saturation probe and the Philips FAST pulse oximeter system. The study will include 50 adult patients and 25 pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Adult subjects (aged 18 years or older) willing and able to understand and provide written informed consent
* Paediatric subjects aged 16 years and older willing and able to understand and provide written informed consent
* Paediatric subjects aged approx. 4-16 years and their legal guardians, willing and able to understand and provide written informed consent/assent
* Subject weight within intended use of at least one SpO2 sensor under test at time of enrolment (M1191T: adult patients \>50kg, M1196T: adult patients \>40kg, M1192A: paediatric patients 15-50kg)
* Willing and able to wear study devices during study procedures
* Subject undergoing regular spot-check measurements as per the site's standard of care

Exclusion Criteria:

* Palliative patients
* Critically ill patients with severe physiological instability (NEWS ≥9)
* Injury/wounds or physical malformation of sensor application site (i.e. fingers, toes, hands, feet)
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
* Unwillingness or inability to remove coloured nail polish or artificial nails from application site
* Nail fungus on application site
* Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site

Primary outcomes:
measure: Data collection for database for algorithm development
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wales
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
state: Bangor
Study officials:
affiliation: Betsi Cadwaladr University Local Health Board
name: Christian P Subbe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05804461: Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico
Official title: Optimizing PrEP Uptake Among Latino MSM in Puerto Rico: A Comparative Effectiveness Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 182
Sex: MALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino Men Who Have Sex With Men (MSM) in Puerto Rico.


Eligibility criteria: Latino MSM group - Inclusion Criteria:

* Biological male
* Age 21 or older
* Self-reported HIV negative or unknown status
* Not using PrEP (participants who have discontinued PrEP use can participate in the study), Spanish fluency (ability to write and read in Spanish)
* Presenting at least one of the eligibility criteria for PrEP as established by the CDC (including men who have had an infection (STI) in the past 6 months, HIV positive sexual partner)
* Access to a portable technology device (e.g., phone, tablet, laptop) or desktop computer access to internet connection

Exclusion Criteria:

* HIV positive individual
* Evidence of being under the effects of alcohol or drugs
* Indication of unstable or serious psychiatric symptoms
* Evidence of major cognitive impairment
* Inability to speak and read in Spanish

Healthcare Providers group - Inclusion Criteria:

* Age 21 or older
* Providing PrEP related health services at time of enrollment (e.g., case management, clinical services)
* Spanish fluency (ability to write and read in Spanish)

Exclusion Criteria:

* Evidence of being under the effects of alcohol or drugs
* Indication of unstable or serious psychiatric symptoms
* Evidence of major cognitive impairment
* Inability to speak and read in Spanish

Primary outcomes:
measure: Primary
timeFrame: 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
References:
Clinical trial NCT04595461: Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery
Official title: Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 80
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: Chronic rhinosinusitis treatment consists of medical management and surgical intervention. Improving patient education can positively impact perioperative patient experiential outcomes such as anxiety, pain and satisfaction. However, online education materials are often too complex, inaccurate or misleading. The objective of this study was to determine if patient education videos at an appropriate reading level would improve perioperative anxiety in patients undergoing endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* English speaking
* diagnosed with CRS according to Canadian Guidelines
* computer or mobile phone access were included

Exclusion Criteria:

* immunocompromised
* had sinonasal tumours
* history of anxiety, depression, bipolar, or any other mental illnesses

Primary outcomes:
measure: Pre-operative Patient Anxiety
timeFrame: 1 hour preoperatively
measure: Pre-operative Patient Anxiety
timeFrame: 1 hour preoperatively
Secondary outcomes:
measure: Post-operative Anxiety
timeFrame: 1 week post-operative
measure: Post-operative Anxiety
timeFrame: 1 week post-operative
measure: Post-operative Pain
timeFrame: 1 week post-operative
measure: Post-operative Satisfaction
timeFrame: 1 week post-operative
measure: Post-operative medication adherence
timeFrame: 1 week post-operative
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Andrew Thamboo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618461: PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)
Official title: PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Understanding of Medication Instructions
Recall of Medication Instructions
Keywords: Prescription drug information
Medication management
Lead sponsor: PictureRx, LLC
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Research shows that well-developed icons and other pictorials aid in the comprehension of medication information and are effective in improving patients' medication management. This experimental study seeks to test the effect of icons and structured medication information on subjects' processing and recall of simulated medication instructions in a computer testing environment. The study planned to enroll 200 subjects.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Fluency in English or Spanish
* Manage their own prescription medicines, and
* Be taking at least one chronic medication

Exclusion Criteria:

* Too ill to complete the experiment
* Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
* Inability to communicate in either Spanish or English
* Overt psychiatric illnesses, overt delirium or dementia

Primary outcomes:
measure: Understanding of medication instructions
timeFrame: Within 10-20 minutes
Secondary outcomes:
measure: Recall of medication instructions
timeFrame: Within 10-20 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Saint Thomas Family Health Center - West
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Family Health Center - South
state: Tennessee
Study officials:
affiliation: PictureRx, LLC
name: M Brian Riley, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06146361: Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19
Official title: Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Latino Day Laborers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-11-24
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work

Exclusion Criteria:

* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours

Primary outcomes:
measure: Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
timeFrame: Baseline
measure: Number of Participants Compliant With COVID Vaccination Guidelines as Assessed by a Survey
timeFrame: 4 weeks post intervention
measure: Mask Wearing Frequency as Assessed by a Survey
timeFrame: Baseline
measure: Mask Wearing Frequency as Assessed by a Survey
timeFrame: 4 weeks post intervention
measure: Percentage of Participants Who Contacted an Agency About the Gold Card
timeFrame: 4 weeks post intervention
measure: Percentage of Participants Who Reported Contacting the Agency for Assistance to Get Food
timeFrame: 4 weeks post intervention
measure: Percentage of Participants Who Reported Contacting the Agency for Assistance With Health Care Resources
timeFrame: 4 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez-Esquer, PhD
role: PRINCIPAL_INVESTIGATOR
References: