louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06901713: Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial
Official title: Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation; Tobacco Dependence
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 2000
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: This protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. One method provides only CBT text messages (Group A), while the other combines CBT text with mindfulness audio (Group B). The study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation.

This study investigates the effects of two different smoking cessation interventions: (1) CBT text-based program alone (Group A), and (2) CBT text combined with mindfulness audio (Group B). The primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.

Detailed description: Design: A randomized controlled trial (RCT) will be used to compare the outcomes of the two intervention groups.

Setting: The study will be conducted online. Participants will access the CBT text materials through a dedicated platform and the mindfulness audio via a compatible device. Recruitment will be done through social media, community outreach, and online advertisements.

Eligibility criteria: Inclusion Criteria:

* Who smoke at least 5 cigarettes per day.
* Express a desire to quit or reduce smoking.
* Who has the ability to access and use the provided digital materials.

Exclusion Criteria:

* Those currently enrolled in other smoking cessation programs.
* Individuals with severe psychiatric disorders that may interfere with participation.
* Those without access to the necessary digital devices.

Primary outcomes:
measure: Biological Verification of Abstinence
timeFrame: 6 Months
Secondary outcomes:
measure: Smoking Frequency
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
measure: Craving Intensity
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
measure: Emotional Regulation
timeFrame: Baseline, Week 12, and Week 26
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
Study officials:
References:
citation: Li S, Meng L, Chiolero A, Ma C, Xi B. Trends in smoking prevalence and attributable mortality in China, 1991-2011. Prev Med. 2016 Dec;93:82-87. doi: 10.1016/j.ypmed.2016.09.027. Epub 2016 Sep 24.
citation: Li Q, Hsia J, Yang G. Prevalence of smoking in China in 2010. N Engl J Med. 2011 Jun 23;364(25):2469-70. doi: 10.1056/NEJMc1102459. No abstract available.
Clinical trial NCT00295113: Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions
Official title: Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary arterial pressure
COPD
Cardiac output
pulmonary and cardiac functions
pulmonary arterial pressure measurements
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.


Eligibility criteria: Inclusion Criteria:

* COPD patients (male and female) with moderate obstruction (FEV1/CV\<60%)

Exclusion Criteria:

* acute respiratory disease
* any type of cardiac disease

Primary outcomes:
measure: The pulmonary arterial pressure does not increase dramatically during the 30 minutes exercise test, but decreases significantly after the first 5 minutes of exercise.
Secondary outcomes:
measure: The cardiac output is stable after the first 5 minutes of exercise, despite the high intensity work loads every 5 minutes.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
name: Ruddy RICHARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpitaux Universitaires de Strasbourg - Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
name: Evelyne LONSDORFER-WOLF, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190513: Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease
Official title: Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease and Prevalence of Celiac Disease in Children With Eosinophilic Esophagitis in a Tertiary Community Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Eosinophilic Esophagitis
Lead sponsor: St. John Health System, Michigan
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children seen in the Pediatric Gastroenterology clinic at St. John Hospital \& Medical Center and diagnosed with celiac disease or eosinophilic esophagitis or both based on the endoscopic and histopathological findings.

Brief summary: Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the gastrointestinal tract with specific clinico-pathological characteristics. In recent years, in the literature, several children who underwent upper gastrointestinal endoscopy for suspected CD, which was confirmed histologically, were also found to have coexistent EE. There are reports of coexistent CD and EE. We would like to see the prevalence of EE in children with CD and the prevalence of CD in children with EE in our population, and to do so would like to review medical records. Our objectives are to determine if children with celiac disease have a high prevalence of eosinophilic esophagitis.and to determine if children with eosinophilic esophagitis have increased risk of developing celiac disease.


Eligibility criteria: Inclusion Criteria:

* Seen in the Pediatric Gastroenterology clinic at St. John Hospital \& Medical Center during study time frame
* Age 2-21 years old
* Diagnosed with CD or EE or both based on the endoscopic and histopathological findings .

Exclusion Criteria:

* Gastroesophageal reflux diagnosed by PH probe.
* History of chemical ingestion

Primary outcomes:
measure: Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field.
timeFrame: Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03252613: Translational Approaches to Septic Cardiomyopathy
Official title: Translational Approaches to Septic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathies
Sepsis
Septic Shock
Keywords: septic cardiomyopathy
cytokine
iPSC
Inducible pluripotent stem cell
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Euan Ashley
First posted: 2017-08-17
Enrollment: 24
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: The population of study subjects must be 18 years of age, admitted to an ICU and have sepsis or septic shock as defined in the above inclusion criteria.

Brief summary: This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.


Eligibility criteria: INCLUSION CRITERIA

At least 18 years of age Admitted to the ICU

SEPSIS PATIENTS:

Sepsis patients must have:

1. Suspected or confirmed infection AND
2. Organ dysfunction as defined by a SOFA \>= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:

1. Suspected or confirmed infection AND
2. Lactate \> 2 mmol/L AND
3. Receiving vasopressors

EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known preexisting heart disease Known severe valvular disease (regurgitation or stenosis)

Major cardiac dysrhythmia such as:

* Ventricular tachycardia (V-tach)
* Ventricular Fibrillation (V-fib)
* Third degree heart block (complete hear block or complete AV block)

Primary outcomes:
measure: Correlation of cytokine profile with left ventricular global longitudinal strain
timeFrame: Day 1
Secondary outcomes:
measure: Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes
timeFrame: Day 1
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Murray
country: United States
facility: Intermoutain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Samuel Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Euan Ashley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847113: Maximal and Self-selected Walkingspeed After Knee Arthroplasty - a Prospective Cohort Study
Official title: MAXIMAL and SELF-SELECTED WALKING SPEED AFTER KNEE ARTHROPLASTY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Arthroplasty, Total
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 130
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with knee osteoarthritis scheduled for knee arthroplasty at Lovisenberg Diaconal Hospital who meet the eligibility criteria

Brief summary: The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.


Eligibility criteria: Inclusion Criteria: age 55 +, living in or near the city of Oslo (up to appox 2 hours commute), sceduled for primary knee arthroplasty, able to walk independently with or without walking aids, understand and speak Norwegian sufficently to take instructions and respond to questionnaires

Exclusion Criteria:

Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)

Primary outcomes:
measure: Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn
timeFrame: Baseline, 3 months and 12 months after surgery
Secondary outcomes:
measure: Sit-to-stand
timeFrame: Baseline, 3 months and 12 months after surgery
measure: One legged stance
timeFrame: Baseline, 3 months and 12 months after surgery
measure: Knee specific function and pain
timeFrame: Baseline and 12 months
measure: EQ5D- Health-related quality of life
timeFrame: Baseline and 12 months after surgery
Other outcomes:
measure: Physical activity
timeFrame: Baseline and 12 months after surgery
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
References:
Clinical trial NCT05002413: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis
Official title: NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia Sepsis
Keywords: Bacteremia Sepsis Antibiotic Susceptibility Testing AST Gram-negative
Resistell Phenotech
Nanomotion
Cantilever
Lead sponsor: Resistell AG
Sponsor class: INDUSTRY
Collaborators: name: Innosuisse - Swiss Innovation Agency
First posted: 2021-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bacteremia considered to be due to a pathogenic strain who have been hospitalized at CHUV at the time of blood culture inoculation

Brief summary: Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device.

Detailed description: NANO-RAST: Nano-motion based Resistell AST to determine the antibiotic susceptibility of bacteria causing bacteremia and sepsis.

Study population: patients admitted at the study site with bacteremia considered to be due to a pathogenic strain (E. coli or K. pneumoniae).

Study design: prospective, observational, single arm study.

Eligibility criteria: Inclusion Criteria: The patients meeting all the following criteria can be recruited in the study:

* patients over the age of 18 years who sign, or their relatives / legal representatives sign the informed consent form;
* patients with bacteremia considered to be due to a pathogenic strain;
* patients hospitalized at CHUV at the time of blood culture inoculation;
* patients whose positive blood cultures were not older than 24 hours at the time of AST start.

Exclusion Criteria The patients meeting any of the following criteria will be excluded from the study:

* patient is diagnosed with polymicrobial bacteremia;
* samples can be excluded from the study during the processing of samples in case of technical errors e.g. failure with attachment of cells, technical problem with the device or sensor, operator's error, etc.

Note: in the event that the capacity of the Resistell instruments is reached for the day, no more ICFs will be obtained for the day.

Primary outcomes:
measure: Sensitivity of Resistell AST
timeFrame: Approximately 30 months
Secondary outcomes:
measure: Accuracy and Specificity of Resistell AST
timeFrame: Approximately 30 months
measure: Time to Result (TTR)
timeFrame: Approximately 30 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Institut de microbiologie CHUV R , Suisse +41 21 314 4056
state: Vaud
Study officials:
References:
Clinical trial NCT00994513: Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Official title: Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Cardiovascular Disease
Type 2 Diabetes
Keywords: Antioxidant
Obesity
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Xinjiang Medical University
First posted: 2009-10-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.


Eligibility criteria: Inclusion Criteria:

* Han ethnicity
* BMI≥25kg/m2
* Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP\<140mmHg or 85mmHg≤DBP\<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C\<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L)
* 18-60 years old
* Not on any antioxidant vitamin supplement

Exclusion Criteria:

* Pregnancy, lactation or child-bearing age without birth control device
* History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease
* Anything that would impede the subject from complying with the ALA treatment
* History of psychiatric problems

Primary outcomes:
measure: Biomarkers of oxidative stress
timeFrame: 2 months
measure: Insulin sensitivity
timeFrame: 2 months
measure: Endothelial function
timeFrame: 2 months
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 2 months
measure: Blood pressure
timeFrame: 2 months
measure: Fasting lipid profile
timeFrame: 2 months
measure: Pulse wave velocity
timeFrame: 2 months
Other outcomes:
Locations:
city: Urumqi
country: China
facility: Xinjiang Medical University
state: Xinjiang
Study officials:
References:
Clinical trial NCT02031913: Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD
Official title: Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Hepatic Fibrosis
Fatty Liver
Keywords: Chronic hepatitis B
Hepatic fibrosis
Steatosis
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography

Brief summary: Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.

Detailed description: acoustic radiation force impulse elastography

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B patients
* With evidences of hepatic steatosis on ultrasonography or pathology

Exclusion Criteria:

* significant alcohol consumption or other known liver diseases

Primary outcomes:
measure: Insulin resistance and fibrosis indices
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Won Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457313: Pain Compared Between the First and the Second Surgery in Staged BTKA
Official title: Comparison of Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: Clinical Evidence That Central Sensitization Increases Systemic Pain Sensitivity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 34
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing elective bilateral staged total knee arthroplasty

Brief summary: postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).

Detailed description: postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia,
* age \<=85
* American Society of Anesthesiologists physical status of I to II

Exclusion Criteria: any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.

Primary outcomes:
measure: VAS
timeFrame: from the end of the TKA surgery until postoperative 48 hour
Secondary outcomes:
measure: analgesic consumption
timeFrame: from the end of the TKA surgery until postoperative 48 hour
measure: rescue analgesic
timeFrame: from the end of the TKA surgery until postoperative 48 hour
measure: antiemetics
timeFrame: from the end of the TKA surgery until postoperative 48 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang hopital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sanghwan Do, PhD
role: STUDY_CHAIR
References: