louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01738061: A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
Official title: A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorder
Keywords: Older workers
Multidimensional intervention
Worksite health promotion
Taiwan
Lead sponsor: Asia University
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2012-11-30
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan.

Detailed description: The investigators conducted a quasi-experiment in older workers from three worksites in southern Taiwan.

* Qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities.
* A researcher reviewed the health record and discussed with the subject about his/her health status.
* Subjects in the intervention group received lifestyle interventions. The activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases.
* Subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles.
* Anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).

Eligibility criteria: Inclusion Criteria:

* full-time worker
* aged 50 years or older
* willing to complete a screening questionnaire
* sign a study consent

Exclusion Criteria:

Primary outcomes:
measure: Changes in anthropometric and srum biochemical indicators.
timeFrame: At baseline (week 0) and endpoint (week 24) of the intervention
Secondary outcomes:
measure: Lifestyle factors
timeFrame: At baseline (week 0) and endpoint (week 24) of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Department of Healthcare Administration, Asia University
name: Alan C Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575861: Zileuton and Exhaled Nitric Oxide in Asthmatics
Official title: Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
nitric oxide gas exchange
lung function
Lead sponsor: Gelb, Arthur F., M.D.
Sponsor class: INDIV
First posted: 2007-12-18
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.


Eligibility criteria: Inclusion Criteria:

* Non-smoking
* Moderate to severe persistent asthmatics
* Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months

Exclusion Criteria:

* No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks

Primary outcomes:
measure: nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
timeFrame: 2 hr to 1 month
Secondary outcomes:
measure: expiratory spirometry and asthma symptom Juniper score
timeFrame: 2 hr to 1 month
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Arthur F Gelb Medical Corporation
state: California
Study officials:
References:
citation: Gelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S
citation: Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9. doi: 10.1378/chest.129.6.1492.
citation: Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. doi: 10.1164/rccm.200403-408OC. Epub 2004 Jun 30.
citation: Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23.
Clinical trial NCT01006161: Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
Official title: Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 0
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: Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.


Eligibility criteria: Inclusion Criteria:

* Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.

Exclusion Criteria:

* Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

Primary outcomes:
measure: Severe asthma exacerbations, pulmonary function test data, and a change in symptoms
timeFrame: Measured over the duration of the trial.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01782261: Incretin Effect on the Immunological Phenotype
Official title: Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: autoimmune disease
diabetes type 1
incretin effect
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Detailed description: Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

Eligibility criteria: Inclusion Criteria:

-healthy subjects or patients with type 1 diabetes

Exclusion Criteria:

* pregnancy
* treatment with GLP-1-Analoga (Liraglutide, Exenatide)
* treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Primary outcomes:
measure: Increase of regulatory FOXP3+ T cells
timeFrame: 4 weeks
Secondary outcomes:
measure: Immunophenotyping
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas R Pieber, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05182983: Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
Official title: Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Tract Diseases
Liver Diseases
Colorectal Disease
Gastric Diseases
Small Bowel Disease
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 10690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with gastrointestinal diseases and healthy people

Brief summary: The tongue images of patients with gastrointestinal diseases and healthy people will be collected and the tongue image database will be established. Through deep learning and artificial intelligence, early screening models of various gastrointestinal tumors based on tongue images were constructed.


Eligibility criteria: Inclusion Criteria:

1. Be older than 18 years old;
2. Clinical or pathological diagnosis of Digestive tract diseases;
3. Patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures；
4. The patient had no tongue disease
5. Patients understand and are willing to sign written informed consent.

Exclusion Criteria:

1. Patients unable to complete the process as required (mental disorder or poor compliance, etc.);
2. The patient or guardian is unwilling to participate in this study;
3. Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);

Primary outcomes:
measure: Diagnosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Gang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01308983: Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prehypertension
Keywords: Prehypertension
Flow mediated dilation
Pulse wave velocity
carotid compliance
Prehypertension and amiloride
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.


Eligibility criteria: Inclusion Criteria:

* Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
* Male or female of Caucasian or African-American origin.
* No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
* Not taking any medication that affects blood pressure.

Exclusion Criteria:

* HbA1C \> 7.0 % during screening visit.
* Serum potassium \> 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 50 ml/min\* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
* Female having positive pregnancy test during screening and/or any testing visit.

Primary outcomes:
measure: Vascular phenotypes
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
References:
citation: Bhagatwala J, Harris RA, Parikh SJ, Zhu H, Huang Y, Kotak I, Seigler N, Pierce GL, Egan BM, Dong Y. Epithelial sodium channel inhibition by amiloride on blood pressure and cardiovascular disease risk in young prehypertensives. J Clin Hypertens (Greenwich). 2014 Jan;16(1):47-53. doi: 10.1111/jch.12218. Epub 2013 Oct 31.
Clinical trial NCT06820983: Evaluation of the Quality of Life of Patients with DBB with the Installation of OPEP
Official title: Evaluation of the Quality of Life of Patients with DBB with the Installation of OPEP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiectasis
Quality of Life
Physiotherapy
Keywords: quality of life
Bronchiectasis
oscillating PEP devices
physiotherapy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Hôpital Armand Trousseau
First posted: 2025-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To carry out an assessment of compliance and quality of life in a population (children and adults) with DDB before and after the use of an oscillating PEP. The aim is to determine the impact of the use of oscillating PEP on the daily life of this population in particular.


Eligibility criteria: Inclusion Criteria:

* Children (from 8 years of age) and adults over 18 years of age with DDB who doesn't use oscillating PEP.

The study population will be clinically stable and will be seen in follow-up consultations.

Exclusion Criteria:

* Children under 8 years of age.
* Patients who use an OPEP
* Patients in the acute exacerbation phase of their DDB
* Patients who are not under regular consultation
* Patients with severe, uncontrolled co-morbidities
* Patients with cognitive or psychiatric disorders preventing proper adherence to the study protocol
* Patients taking part simultaneously in another clinical study that could interfere with the results of the OPEP study

Primary outcomes:
measure: Variation of patient quality of life before and after OPEP installation
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT03247283: Pharmacokinetics and Metabolism Study in Healthy Male Participants
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986205 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males


Eligibility criteria: Inclusion Criteria:

* Body weight 75-95kg, BMI 18.0-32.0 kg/m\^2
* Refrain from sperm donation 110 days after dosing

Exclusion Criteria:

* Current or recent gastrointestinal disease
* Any GI surgery that could impact drug absorption
* Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
timeFrame: up to 28 days
measure: Percent of Total Radioactivity Recovered in All Excreta (% total)
timeFrame: up to 28 days
measure: Half-Life (T-HALF)
timeFrame: up to 28 days
measure: Total Body Clearance (CLT)
timeFrame: up to 28 days
measure: Volume of Distribution during Terminal Elimination Phase (Vz/F)
timeFrame: up to 28 days
measure: Time to Maximum Observed Concentration (Tmax)
timeFrame: up to 28 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: up to 28 days
measure: Results of electrocardiogram tests (ECGs)
timeFrame: up to 28 days
measure: Results of vital sign measurements
timeFrame: up to 28 days
measure: Results of clinical laboratory tests
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol- Myers Squibb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711761: Ideal Depth of Guide Wire for Central Catheterization
Official title: Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety During Central Venous Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: prospective randomized double-blind controlled study

Detailed description: Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.

Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)

Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.

An investigator will monitor and record whether any arrhythmia will occur.

The incidence of occurrence of arrhythmia will be compared between three groups.

Eligibility criteria: Inclusion Criteria:

* patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
* ASA (American Society of Anesthesiologist) physical status class I or II

Exclusion Criteria:

* at the pre-anesthetic evaluation, history of any arrhythmia
* when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
* abnormal electrolyte at the pre-anesthetic evaluation
* too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)

Primary outcomes:
measure: Incidence of arrhythmia
timeFrame: during central venous catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Jung-Man Lee, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02982083: Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis
Official title: Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Raloxifene
Disease activity
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 34
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators select 40 postmenopausal women suffering from RA with 2.5\<DAS28\<5.5 referring to rheumatology clinics of Mashhad university of medical sciences and randomly divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are administered double blind. In the beginning, total bone mineral density (BMD) assessment is carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3 months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At the end of month 3, disease activity and probable complications are evaluated and compared in 2 groups. Classic regimen should be started for every patient who doesn't enter remission phase in first 3 months.

In 4th month, DMARD regimen is administered and then patients are visited every 2 months. Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another total BMD test is carried out and then data are analyzed including changes in BMD, DAS28, EULAR response criteria and HAQ-DI score.


Eligibility criteria: Inclusion Criteria:

* Patients are postmenopausal women.
* Patients should fit at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis.
* Patients should be in range of 2.5 \<DAS28-ESR \<5.5

Exclusion Criteria:

* Patients with history of thrombotic events
* Patients suffering from another rheumatic diseases simultaneously
* Patients with sever symptoms of menopause
* Patients with known psychological diseases

Primary outcomes:
measure: Evaluation of DAS-28 criteria
timeFrame: 3 months
measure: Assessing of complications
timeFrame: 3 months
Secondary outcomes:
measure: DAS-28 criteria
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
measure: EULAR criteria
timeFrame: 12 months
measure: HAQ-DI criteria
timeFrame: 12 months
measure: Assessing of Bone Marrow Density score
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Maryam Sahebari, Professor
role: STUDY_DIRECTOR
References: