louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04430803: Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging
Official title: The Effects of Six-month Hydrogen-rich Water Intake on Molecular and Phenotypic Biomarkers of Aging in Men and Women Aged 70 Years and Over: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 44
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of six-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in men and women aged 70 years and over.


Eligibility criteria: Inclusion Criteria:

* Age \> 70 years
* Free of acute disorders

Exclusion Criteria:

* History of dietary supplement use during the past 4 weeks

Primary outcomes:
measure: Change in TeloTAGGG Telomerase PCR activity in serum
timeFrame: Baseline vs. 6 months post-intervention
Secondary outcomes:
measure: Change in DNA methylation
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in blood concentration of advanced glycation end product
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in lipid peroxidation
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in serum FGF21
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in serum TET2
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in ADAS-Cog score (0-70 scale, higher scores indicating greater cognitive impairment)
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in facial wrinkling (0-100 scale; higher scores mean worse outcome)
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in maximal oxygen uptake estimated by step-in-place test
timeFrame: Baseline vs. 6 months post-intervention
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied Bioenergetics Lab
state: Vojvodina
Study officials:
References:
citation: Xia X, Chen W, McDermott J, Han JJ. Molecular and phenotypic biomarkers of aging. F1000Res. 2017 Jun 9;6:860. doi: 10.12688/f1000research.10692.1. eCollection 2017.
citation: Zanini D, Todorovic N, Korovljev D, Stajer V, Ostojic J, Purac J, Kojic D, Vukasinovic E, Djordjievski S, Sopic M, Guzonjic A, Ninic A, Erceg S, Ostojic SM. The effects of 6-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in older adults aged 70 years and over: A randomized controlled pilot trial. Exp Gerontol. 2021 Nov;155:111574. doi: 10.1016/j.exger.2021.111574. Epub 2021 Oct 1.
Clinical trial NCT04653103: NASH in Subjects With Different Classes of Obesity
Official title: Prevalence of NASH in Subjects With Different Classes of Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NASH - Nonalcoholic Steatohepatitis
NAFLD
Obesity
Obesity, Morbid
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with different classes of obesity

Brief summary: It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.

Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 69 years

Exclusion Criteria:

* Pregnancy
* Active cancer
* End stage renal failure
* End stage liver failure
* Being unable to understand and sign informed consent

Primary outcomes:
measure: Prevalence of NASH
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of lipid profile
timeFrame: 6 months
measure: Assessment of glycemic profile
timeFrame: 6 months
measure: Assessment of glycated hemoglobin
timeFrame: 6 months
measure: Assessment of liver enzymes
timeFrame: 6 months
measure: Assessment of insulin
timeFrame: 6 months
measure: Assessment of metabolic profile
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: University of Rome Sapienza
city: Rome
country: Italy
facility: Catholic University School of Medicine
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Geltrude Mingrone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01891903: to Translate and Validate the TOPAS TORONTO PSORIATIC SCREENING QUESTIONNAIRE)Into Spanish
Official title: TO TRANSLATE AND VALIDATE THE ToPAS (TORONTO PSORIATIC SCREENING QUESTIONNAIRE) FOR THE SCREENING OF PSORIATHIC ARTHRITIS PATIENTS IN DERMATOLOGY CLINICS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriatic Arthritis
Lead sponsor: Reumatologia Integral LTDA
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PATIENTS WITH PSORIASIS ASESSED IN THE DERMATOLOGY CLINIC

Brief summary: TO TRANSALETE AND VALIDATE DE TORONTO PSORIATIC ARTHRITIS SECREENING QUESTIONAIRE INTO SPANISH

Detailed description: THIS IS PART OF THE COLOMBIAN REGISTRY OF PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS

Eligibility criteria: Inclusion Criteria:

* ADULT WITH PSORIASIS IN THE DERMATOLOGY CLINIC

Exclusion Criteria:

* ADULT WITH OTHER AUTOIMMUNE DISEASE

Primary outcomes:
measure: The Kuder Richardson Coefficient of reliability (K-R 20)
timeFrame: 4 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Clinica San Rafael
state: Cundinamarca
Study officials:
affiliation: hospital san ignasio
name: Daniel Fernandez, rheumatolo
role: STUDY_DIRECTOR
References:
Clinical trial NCT05084703: Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
Official title: Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Latarjet
Shoulder Injuries
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-10-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.

Detailed description: The different objectives of this study are :

* To assess the intra- and intersessional reproducibility of functional shoulder tests
* To evaluate the influence of an anterior front stop using the Latarjet method on the functional profile of the shoulder compared to a healthy population.

Eligibility criteria: Inclusion Criteria:

Patient group :

* Male patient
* Between 18 and 30 years-old
* Occurrence of the injury requiring surgery during a sports activity
* Reduction of shoulder instability by the Latarjet technique
* Surgery performed by surgeon from Santy orthopedic center (Lyon)
* Patient's inclusion by decision of the surgeon during the 4 months postoperatively visit

Healthy volunteer group :

* Male patient
* Between 18 and 30 years-old
* Patient regularly practicing sport activity.

Both groups :

* Patient having signed an informed consent
* Affiliated subject or beneficiary of a social security scheme

Exclusion Criteria:

Patient group :

* Contra indication from surgeon
* Having another pathology in the upper limbs
* Present a constitutional hyperlaxity
* Have stiffness or recurrence of dislocation of the shoulder post-surgery

Healthy volunteer group :

* Report a history of upper extremity pain / injury within the past 12 months
* Report a history of orthopedic surgery on the upper limbs

All participants :

* Protected subject : adult under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision
* pregnant woman, breastfeeding, parturient

Primary outcomes:
measure: Symmetry indices between the two limbs obtained thanks to the scores of the functional tests
timeFrame: 1 hour
measure: Muscle endurance index obtained from functional test scores
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital privé Jean Mermoz
Study officials:
References:
Clinical trial NCT06092203: Quality of Life for Pediatric Urolithiasis
Official title: Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric ALL
Keywords: Urolithiasis
Quality of life
PCNL
SWL
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients with urolithiasis.

Brief summary: The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.

Detailed description: This study will assess the quality of life (QoL) in pediatric patients with urinary stone disease using the pediatric quality of life (PedsQol) questionnaire in comparison to normal healthy age/sex matched population.

Eligibility criteria: Inclusion Criteria:

* Patients who had urinary stones

Exclusion Criteria:

1. Patients presenting with obstructive uropathy or urosepsis.
2. Recent (less than 4 weeks) surgical intervention for urinary stone disease.
3. Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).
4. Associated mental illness or cognitive dysfunction.
5. Associated chronic medical illness that may compromise QoL.

Primary outcomes:
measure: The PedsQL questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
affiliation: Mansoura University
name: Ahmed R EL-Nahas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06804603: A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
Official title: A Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight Class I or Class II Obese Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: GLP-1R agonist
semaglutide
obesity
nausea
vomiting
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index 25-40 kg/m\^2 inclusive
* No serious medical problems or chronic diseases, specifically no type I or type II diabetes

Exclusion Criteria:

* Another disorder that contributes to gastrointestinal symptoms
* History of intolerance and/or hypersensitivity to NK-1 receptor antagonists
* History of intolerance and/or hypersensitivity to GLP-1 receptor agonists
* Exposure to any investigational medication within the past 60 days

Primary outcomes:
measure: Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.
timeFrame: 1 week
Secondary outcomes:
measure: Individual gastrointestinal symptoms
timeFrame: 1 week
measure: Safety and tolerability of tradipitant after administration of semaglutide as measured by spontaneous reporting of adverse events (AEs)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Rochester
country: United States
facility: Vanda Investigational Site
state: Minnesota
Study officials:
affiliation: Vanda Pharmaceuticals
name: Vanda Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02228603: Exercise as a Life-long Medicine in Patients With Coronary Artery Disease
Official title: How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Myocardial Infarction
Angina (Stable)
Keywords: exercise therapy
rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
First posted: 2014-08-29
Enrollment: 161
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: Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.

The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.


Eligibility criteria: Inclusion Criteria:

* myocardial infarction, stable angina, heart surgery
* finished phase 2 cardiac rehabilitation
* clinically stable
* able to communicate in Norwegian
* able to do a maximal treadmill test

Exclusion Criteria:

* unstable angina
* serious cardiac arrhythmia
* serious heart valve insufficiency
* heart failure
* any contraindication for high intensity exercise training
* participation in other exercise study
* pregnancy
* cognitive impairment
* drug abuse

Primary outcomes:
measure: change in peak oxygen uptake
timeFrame: 2 years
Secondary outcomes:
measure: physical activity
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
measure: depression
timeFrame: 2 years
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Asbjørn Støylen, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01491503: A Drug Interaction Study of Montelukast and Levocetirizine
Official title: Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: montelukast
levocetirizine
interaction
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14days of screening

Primary outcomes:
measure: AUClast
timeFrame: 0-36hrs
measure: Cmax
timeFrame: 0-36hrs
Secondary outcomes:
measure: Tmax
timeFrame: 0-36hrs
measure: T1/2
timeFrame: 0-36hrs
measure: AUCinf
timeFrame: 0-36hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03921203: ApoB48 Metabolism in Plasma and Interstitial Fluid
Official title: ApoB48IC2 Metabolism in Plasma and Interstitial Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.

Brief summary: Postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apoB-48 (Chylomicron) in blood is a specific marker for intestinal derived lipoproteins. Specific aim: To determine if apoB-48 containing lipoproteins may appear in IC in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in IF and plasma.

Methodology: Intercellular fluid will be collected using the cup technique. IF will be collected in intervals corresponding to different periods after food intake. The IF from these different occasions will then be analysed and compared using FPLC and Elisa.


Eligibility criteria: Inclusion Criteria:

* Over 18 years.
* For the T2D study group: Diagnosed with type 2 diabetes.

Exclusion Criteria:

For subjects with type 2 diabetes:

* Systemic inflammatory disease that requires active treatment
* Thyroid disease that requires active treatment
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Treatment with oral glucocorticoids
* Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range
* Pregnancy

For healthy controls:

* Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Blood pressure pronouncedly above 140/90
* Blood test results pronouncedly outside the reference range
* Pregnancy

Primary outcomes:
measure: ApoB48 levels in blood and interstitial fluid
timeFrame: 7 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Patient research centre, Clinic of endocrinology, Karolinska University Hospital
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Mats Rudling
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195403: A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Official title: A Drug Use Investigation of Enbrel for Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 1014
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, secondary and tertiary medical centers

Brief summary: The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation.

1. Unknown adverse reactions, especially serious adverse reactions
2. Incidences of adverse reactions under routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the efficacy of the drug

This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.


Eligibility criteria: Inclusion Criteria

Rheumatoid Arthritis

* Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
* Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX

Psoriatic Arthritis

- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs

Exclusion Criteria

* Patients to whom Enbrel is contraindicated as per the local labeling
* Patients with known hypersensitivity to Enbrel or any component of the product
* Patients with sepsis or risk of sepsis
* Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Day 832
measure: Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9
timeFrame: Baseline, Month 3, 9
Other outcomes:
Locations:
city: Kyunggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: