louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01884935: PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Official title: A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Pediatric
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.


Eligibility criteria: Key Inclusion Criteria:

- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)

Key Exclusion Criteria:

* History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
* Prior natalizumab therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: predose (trough) concentrations from multiple dosing (Cpredose)
timeFrame: Up to week 16
measure: maximum plasma concentration (Cmax)
timeFrame: Up to Week 16
measure: time to maximum plasma concentration (Tmax)
timeFrame: Up to Week 16
measure: area under the plasma concentration curve from time of first dose to infinity (AUCinf)
timeFrame: Up to Week 16
measure: apparent clearance (Cl/F)
timeFrame: Up to Week 16
measure: volume of distribution
timeFrame: Up to Week 16
measure: elimination half-life (t1/2)
timeFrame: Up to Week 16
Secondary outcomes:
measure: the average and minimum saturation values of α4 integrin over the dosing interval
timeFrame: Up to Week 16
measure: incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs
timeFrame: Up to Week 16
measure: the presence of anti-natalizumab antibodies
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Cefalu
country: Italy
facility: Research Site
city: Gallarate
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Padua
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06485635: Real-life-persistence to Antifibrotic Treatments
Official title: Real-life-Persistence to Antifibrotic Treatments
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 10646
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.

Brief summary: This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.

Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.


Eligibility criteria: Inclusion criteria:

All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.

Exclusion criteria:

No exclusion criteria will be applied.

Primary outcomes:
measure: Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)
timeFrame: up to 30 months
Secondary outcomes:
measure: AF prevalence in French population
timeFrame: up to 5 years
measure: AF incidence in French population
timeFrame: up to 4 years
measure: Number of AF treated patients split by indication
timeFrame: up to 2 years
measure: Number of patients adherent to AF treatment
timeFrame: up to 30 months
measure: Percentage of the target cumulative dose of treatment received by the patients
timeFrame: up to 30 months
measure: Influence of factors (yes/no) associated with persistence to AF treatments
timeFrame: up to 30 months
measure: Number of patients with switch from one AF treatment to the another with no treatment stop
timeFrame: up to 5 years
measure: Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)
timeFrame: up to 5 years
measure: Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)
timeFrame: up to5 years
measure: Event-free survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Clinityx
Study officials:
References:
Clinical trial NCT06810635: Polyphenol Metabotypes in People with Diabetes Type 2
Official title: Polyphenol Metabotypes in People with Diabetes Type 2
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: polyphenol
transit time
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: University of Parma
name: Universiteit Antwerpen
First posted: 2025-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Flemish T2DM patients and controls from Ghent region.

Brief summary: This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).


Eligibility criteria: Inclusion Criteria:

* all participants
* between 40-85 years
* age-matched individuals without diabetes
* BMI between 18.5-30
* no metabolic syndrome
* persons with T2DM
* at leats 2 years of clinical diagnoses of T2DM
* stable medication use for at least 1 month

Exclusion Criteria:

* pregnancy of breastfeeding
* in last month
* acute use of anti/pre/probiotics
* start of new drug or dietary supplements
* major changes in diet
* major lifestyle changes
* diseases
* Gastrointestinal diseases (inflammatory bowel disease)
* Bariatric surgery
* Other forms of diabetes (cystic fibrosis/MODY/T1DM)
* Heart problems (NYHA 3/4) or previous cardiovascular events
* Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis
* Lung problems (COPD - GOLD 3/4), cystic fibrosis
* Uncontrolled thyroid function disruption in the past 6 months
* Intake of coumarin derivatives and direct oral anticoagulant medication
* Anti-cancer treatment: chemo-/immunotherapy
* Immonosuppressants (transplant)
* Antiepileptic drugs

Primary outcomes:
measure: Differences in polyphenol metabolites in morning urine in persons with type 2 diabetes and in healthy controls.
timeFrame: This will be assessed the morning after ingestion of the pill containing polyphenols
Secondary outcomes:
measure: Differences in polyphenol metabolites in 24h urine in persons with type 2 diabetes and in healthy controls.
timeFrame: Urine will be collected over a 24h period after ingestion of the polyphenol pill.
measure: Transit time
timeFrame: baseline
measure: the capacity of the gut microbiome to degrade polyphenols
timeFrame: baseline
measure: Metabolic health
timeFrame: baseline
measure: lifestyle factors and medical history (A)
timeFrame: baseline
measure: lifestyle factors and medical history (B)
timeFrame: baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Bruno Lapauw, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219335: Discarded Materials Study
Official title: Laboratory Evaluation of De-identified, Developmentally Arrested Embryos of Embryos Diagnosed as Having an Abnormal Number of Chromosomes for Optimization of Techniques for Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: IVF
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing infertility treatment

Brief summary: Use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies

Detailed description: 1- Testing methods or freezing before implementing techniques. 2- Develop cell surgery and micromanipulation techniques. 3- Develop methods to optimize the determinations of genes and chromosomes 4- Quality-assess laboratory equipment. 5- Test proficiency of laboratory staff. 6- Analyze what effects the early development of embryos. 7- Develop new methods and media to allow for higher survival rates of embryos. 8- Develop non-invasive tests for predicting embryo quality to predict IVF success.

Eligibility criteria: Inclusion Criteria:

none

Exclusion Criteria:

none

Primary outcomes:
measure: Methods for freezing -embryos
timeFrame: duration of the study
Secondary outcomes:
measure: Development non-invasive tests
timeFrame: duration of the study
measure: Factors that control embryo development
timeFrame: duration of the study
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of new Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Thomas Molinaro, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137435: Post Marketing Surveillance for ADACEL™ in South Korea
Official title: Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Adacel
Diphtheria
Tetanus
Pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 659
Sex: ALL
Minimum age (years): 11
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".

The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.


Eligibility criteria: Inclusion Criteria :

* Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
* Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.

Exclusion Criteria :

* None

Primary outcomes:
measure: Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
timeFrame: 30 days post-vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
timeFrame: 30 days post-vaccination
measure: Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
timeFrame: 30 days post-vaccination
measure: Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
timeFrame: 7 days post-vaccination
Locations:
city: Jung-gu
country: Korea, Republic of
state: Incheon
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00152035: Safety of SPD465 in Treating Adults With ADHD.
Official title: A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.


Eligibility criteria: Inclusion Criteria:

* Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
* Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria:

* Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
* Females who are pregnant of lactating.

Primary outcomes:
measure: The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
timeFrame: Throughout the study period of approximately 20 months
Secondary outcomes:
measure: ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
timeFrame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
measure: Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
timeFrame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
measure: Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
timeFrame: Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03103035: Enhancing Knowledge Translation in Nutrition Through a Healthy Eating Blog
Official title: Enhancing Knowledge Translation in Nutrition Through a Healthy Eating Blog: A Mixed Methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-04-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if a nutrition intervention provided through a healthy eating blog is feasible and acceptable.

Detailed description: Participants randomised to the experimental group are exposed to one blog post each week for a period of 6 months. Blog posts focus on the improvement of fruits and vegetables consumption targeting four main determinants of the behavior: (1) knowledge; (2) attitude; (3) self-efficacy; and (4) motivation/goals. Each post included a step-by-step recipe developed by the research team and featuring fruits and vegetables. Recipes were described textually and also using pictures and/or video. Twenty-six posts were created over the six-month intervention. Participants randomised to the control group are not exposed to the healthy eating blog. Feasibility (compliance, dropout and participation rates) and acceptability (satisfaction) of the study were assessed.

Eligibility criteria: Inclusion Criteria:

* women aged 18 and older;
* with Internet access as well as an active e-mail address;
* consuming five or less servings of F\&V per day;
* living in the Quebec City metropolitan.

Exclusion Criteria:

* women dieting,
* currently pregnant or lactating.

Primary outcomes:
measure: Compliance rates
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction of the healthy eating blog intervention using Questionnaire
timeFrame: 6 months
measure: Dropout rates
timeFrame: 6 months
measure: Participation rates
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05004935: The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration
Official title: Analysis of Electromyography Activation Trunk Muscles and the Effect of Beetroot Juice Intake on the Results in Strength Exercises: Lateral Medicine Ball Throw and Sled Pushing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration.

A secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.

Detailed description: In a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (NaNO3). Antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption.

Plasma trimethylamine N-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined.

Using Flow Mediated Skin Fluorescence skin NADH content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.

Eligibility criteria: Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

Primary outcomes:
measure: The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration
timeFrame: 4 hours
Secondary outcomes:
measure: The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status
timeFrame: 4 hours
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Akademia Wychowania Fizycznego
Study officials:
affiliation: Poznan University of Physical Education
name: Robert A Olek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03170635: Refreshing Recess: Staff and Student Feedback Outcome Study (EMCRR)
Official title: The Refreshing Recess Program for Promoting Student Participation and Enjoyment: An Outcome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interpersonal Relations
Occupational Therapy
Keywords: recess, occupational therapy
Lead sponsor: Cleveland State University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 485
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Refreshing Recess program was provided one day/week for 6 consecutive weeks.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers.

Detailed description: A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy recess and socialization with peers. Occupational therapy practitioners provide weekly information and coaching to recess supervisors and embed weekly activities into the recess experience (e.g. team building games, strategies for including students with disabilities, etc.).

Eligibility criteria: Inclusion Criteria:

* all kindergarten through 4th grade students in school where the Refreshing Recess program was offered based on principal approval
* all recess supervisors who supervised recess during program implementation

Exclusion Criteria:

- students who did not receive the school-sponsored Refreshing Recess program

Primary outcomes:
measure: Changes in students' participation and enjoyment of recess play and socialization
timeFrame: pretest prior to the program implementation (10 minutes) and posttest 6 weeks later after program implementation (10 minutes)
Secondary outcomes:
measure: Changes in recess supervisors knowledge, beliefs, and actions related to supervising recess
timeFrame: pre-survey prior to program implementation (10 min.) and post-survey following the 6 week program (10 min.)
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland State University
name: Susan Bazyk
role: PRINCIPAL_INVESTIGATOR
References: