louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03440983: OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers
Official title: OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: optimize the imaging protocols
validate technical parameters in healthy volunteers
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam.

The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

Detailed description: Using MRI, many technical parameters (sequence, parameters in the sequence, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the examination.

The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

Prospective, single-center, observational MRI study A screening visit is planned to check the inclusion/non inclusion criteria followed by an imaging visit during which the MRI examination will be performed.

Theses 2 visits are scheduled at the subject's convenience. The number of participations to the study is limited to 5 per year per subject.

Eligibility criteria: Inclusion Criteria:

* Male or female subject,
* Aged 18 or above

Exclusion Criteria:

* Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
* Claustrophobic patient
* Pregnancy
* Breastfeeding
* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
* No healthcare insurance

Primary outcomes:
measure: MRI data acquisition : quality of the images, cartographies or spectres
timeFrame: 0.5 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes cedex 9
country: France
facility: Radiology Department CHU de Rennes
Study officials:
References:
Clinical trial NCT01982461: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
Official title: A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Pin Siang Medical Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 20 to 85;
* LDL - C between 130 mg/dL and 250 mg/dL;
* TG \< 400 mg/dL;
* Who without use of any statin within 2 week prior to the trial;
* Informed consent given.

Exclusion Criteria:

* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy;
* Active liver disease/severe hepatic impairment(Child-Pugh C,ALT2×ULN);
* Treatment with Cyclosporin or any disallowed drug;
* Patients with unstable angina pectoris;
* Pregnant, lactating women;
* Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.

Primary outcomes:
measure: The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.
timeFrame: baseline to week 12
Secondary outcomes:
measure: The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
timeFrame: baseline to week 12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Yi-Jen Hung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749761: Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
Official title: Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: IDH, intradialytic hypotension,
hypotension on hemodialysis,
hemodialysis,
Blood pressure guided biofeedback
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: B. Braun Medical Inc.
First posted: 2012-12-17
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person.

The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.

Detailed description: This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study.

The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.

Eligibility criteria: Inclusion Criteria:

* chronic hemodialysis patients
* history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions

Exclusion Criteria:

* \<19 years
* hemodiafiltration
* expected switch in modality within next 6 months

Primary outcomes:
measure: intradialytic hypotension episodes
timeFrame: By the end of the 8 week intervention period
Secondary outcomes:
measure: urea clearance
timeFrame: 8 weeks
measure: Brain natriuretic peptide
timeFrame: 8 weeks
measure: intradialytic hypotension (blood pressure criteria alone)
timeFrame: 8 weeks
measure: Intradialytic symptoms
timeFrame: 8 weeks
Other outcomes:
measure: Oxygenation saturation
timeFrame: 8 weeks
Locations:
city: Vancouver
country: Canada
facility: St.Paul's Hospital Hemodialysis Unit
state: British Columbia
Study officials:
affiliation: University of Calgary
name: Jennifer M MacRae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138761: Health Literacy for Children With Atopic Dermatitis and Their Caregivers
Official title: Health Literacy for Children With Atopic Dermatitis and Their Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: pediatric atopic dermatitis
EASI
REALM-SF
nurse instruction
health literacy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 33
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic.

Detailed description: The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic. Caregivers of children with atopic dermatitis will be randomized to one of two instruction/education procedures. The goal is to determine if improved retention of information by caregivers/parents of children with atopic dermatitis is associated with better patient outcomes.

Eligibility criteria: Inclusion Criteria:

* New clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to MU dermatology
* Age 7 or under

Exclusion Criteria:

* Age 8 or above

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: EASI administered by blinded investigator at the initial visit, prior to teaching intervention; EASI again administered by same blinded investigator at visit 2 (at 4 weeks).
Secondary outcomes:
measure: Caregiver Questionnaire
timeFrame: Visit 2 (or Week 4 visit)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Dermatology Clinic
state: Missouri
Study officials:
affiliation: University of Missouri, Columbia, MO
name: Gretchen Carlisle, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri, Columbia, MO
name: Jonathan A Dyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842061: Everyday Activity Supports You (EASY) Pilot Study
Official title: Everyday Activity Supports You (EASY) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle
Keywords: active living
retirement
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT) feasibility study of a self-management program to reduce sedentary time and increase physical activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine feasibility and acceptability of the intervention; and the secondary aim is to test the effect of the intervention on the primary health outcome, physical activity (mean daily step count by accelerometry) at 6 months. The investigators will also conduct an economic evaluation and a process evaluation to guide a future larger study and to inform a scaled-up implementation plan.


Eligibility criteria: Inclusion Criteria:

* Healthy community-dwelling women aged 55-70 years who (via self-report) are not currently engaging (or in the previous 3 months) in any strength training, or \<30 minutes brisk walking or moderate exercise/week
* are able to climb stairs and walk 400 meters (e.g., do not have a mobility disability).

Exclusion Criteria:

* Participants who receive treatment for medical conditions that preclude participation in a walking program

Primary outcomes:
measure: Feasibility of Study Recruitment and Retention
timeFrame: 6 months
Secondary outcomes:
measure: Sedentary Time (Measured by Average Daily Percent)
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: Body Composition
timeFrame: 6 months
measure: Active Transportation
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Maureen C Ashe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashe MC, Winters M, Hoppmann CA, Dawes MG, Gardiner PA, Giangregorio LM, Madden KM, McAllister MM, Wong G, Puyat JH, Singer J, Sims-Gould J, McKay HA. "Not just another walking program": Everyday Activity Supports You (EASY) model-a randomized pilot study for a parallel randomized controlled trial. Pilot Feasibility Stud. 2015;1:4. doi: 10.1186/2055-5784-1-4. Epub 2015 Jan 12.
citation: Gray SM, Chen P, Fleig L, Gardiner PA, McAllister MM, Puyat JH, Sims-Gould J, McKay HA, Winters M, Ashe MC. Can a Lifestyle Intervention Increase Active Transportation in Women Aged 55-70 years? Secondary Outcomes From a Pilot Randomized Controlled Trial. J Phys Act Health. 2018 Jun 1;15(6):411-416. doi: 10.1123/jpah.2016-0348. Epub 2018 Mar 23.
Clinical trial NCT01309061: The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
Official title: Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Hemifacial Atrophy
Romberg's Disease
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2011-03-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with progressive hemifacial atrophy.

Detailed description: Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time.

Eligibility criteria: Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :18-75, males and females.
* Patients with symptom of hemifacial atrophy but not progress disease.

Exclusion Criteria:

* Patients with currently progressive hemifacial atrophy.
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Subjects who don't understand purpose and method for this study.
* Patients with psychical disorder or drug and alcohol addiction.
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Primary outcomes:
measure: The volume change of fatty layer
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinical lab tests
timeFrame: 24 weeks
measure: Fat absorption rate
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jong-Woo Choi, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koh KS, Oh TS, Kim H, Chung IW, Lee KW, Lee HB, Park EJ, Jung JS, Shin IS, Ra JC, Choi JW. Clinical application of human adipose tissue-derived mesenchymal stem cells in progressive hemifacial atrophy (Parry-Romberg disease) with microfat grafting techniques using 3-dimensional computed tomography and 3-dimensional camera. Ann Plast Surg. 2012 Sep;69(3):331-7. doi: 10.1097/SAP.0b013e31826239f0.
Clinical trial NCT00423761: An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.
Official title: An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics,
tolerability,
healthy,
subjects
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females.
* Normal ECG.
* Agree to remain in the clinic for the time defined in the protocol.
* Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Active peptic ulcer disease.
* Positive faecal occult blood.
* The subject smokes or has smoked or has used any nicotine-containing products in the last six months.
* Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

Primary outcomes:
measure: Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
timeFrame: on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
Secondary outcomes:
measure: 12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2
timeFrame: day 1 session 1; days 1 & 14 session 2
measure: vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2
timeFrame: day 1 session 1; days 1, 7 & 14 session 2
Other outcomes:
Locations:
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MBChB, MFPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT05770661: China Axial Length Study
Official title: Axial Length Study of Children and Adolescents in Ten Provinces of China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Axial Length, Children, China
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Fujian Medical University
name: Tongji Hospital
name: Sichuan Provincial People's Hospital
name: Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
name: People's Hospital of Ningxia Hui Autonomous Region
name: He Eye Hospital
name: First Affiliated Hospital of Kunming Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The First Affiliated Hospital of Guangxi Traditional Chinese Medical University
First posted: 2023-03-15
Enrollment: 30000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students aged from 3 to 18 years old were recruited from schools to enroll the study.

Brief summary: The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.

30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.


Eligibility criteria: Inclusion Criteria:

* Aged 3 to 18 years
* Have been lived in the research areas for at least one year, and will not move to other places in the following two years
* Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate

Exclusion Criteria:

* Mental diseases, unable to cooperate to complete the eye assessment
* Ophthalmic diseases, inability to cooperate to complete the inspection

Primary outcomes:
measure: Axial length
timeFrame: 2023-2025
Secondary outcomes:
measure: Axial length elongation
timeFrame: 2023-2025
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
Study officials:
References: