louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00739518: Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams
Official title: Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nervous System Diseases
Keywords: Neurological
MRI
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: General Electric
name: Philips Medical Systems
First posted: 2008-08-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.

Detailed description: This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head \& neck regions.

Software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.

Eligibility criteria: Inclusion Criteria:

* If you are a male or a non-pregnant female patient
* Normal volunteer
* presenting to MRI for a clinically-ordered neurological or head and neck MRI exam

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are lactating.
* A patient who is claustrophobic

Primary outcomes:
measure: Improvement in quality of MRI studies in Neuroradiology
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ashok Srivinasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063218: Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
Official title: Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, Atopic
Corticoids, topic
Corticosteroids
Lead sponsor: Galderma Brasil Ltda.
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.


Eligibility criteria: Inclusion Criteria:

* Male or Female patients
* 2 to 10 years old.
* with light to moderate with no signs of acute/ sub-acute eczema or in activity.
* Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
* Subjects can present light to moderate dryness.

Exclusion Criteria:

* Subjects presenting any serious systemic disease
* Subjects with medical history regarding serious asthma
* Subjects with known or suspected allergy to one of the investigational products
* Subjects with acute atopic eczema or in activity, needing systemic antibiotics
* Subjects with signs of active infections on skin
* Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
* Female subjects who are not in pre-menarche period.
* Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
* Patient with a wash-out period for treatment less than:
* injectable corticoids: 60 days
* systemic corticoids: 15 days
* topic corticoids: 8 days
* topic immunomodulator: 8 days
* antihistaminic : 48 hours

Primary outcomes:
measure: clinical evaluation
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
state: Distrito Federal
city: Guarulhos
country: Brazil
facility: Complexo Hospitalar Padre Bento de Guarulhos
state: Sao Paulo
Study officials:
affiliation: Complexo Hospitalar Padre Bento de Guarulhos
name: Mario C Pires, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário de Brasília
name: Izelda Costa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00786318: Ziprasidone vs Standard Therapy for Agitated Patients in the ED
Official title: Prospective Double Blind Randomized Trial of Intramuscular Ziprasidone Compared With Standard Antipsychotic Therapy For The Treatment Of The Acutely Agitated Patient In The Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Psychosis
Agitation
Delirium
Keywords: Psychosis
Agitation
Delirium
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. The primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.


Eligibility criteria: Inclusion Criteria:

* Acutely agitated
* Requires chemical sedation

Exclusion Criteria:

* Physician preference for a specific chemical sedative
* Known allergy to any study medications

Primary outcomes:
measure: length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made
timeFrame: During ED stay
Secondary outcomes:
measure: Length of time taken to sedate patient
timeFrame: Ed visit
measure: Total time spent in restraints
timeFrame: ED visit
measure: Cost effectiveness of the therapy
timeFrame: ED visit
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: The George Washington University Medical Center, Dept of Emergency Medicine
state: District of Columbia
Study officials:
References:
citation: Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. doi: 10.1016/j.annemergmed.2005.08.025. Epub 2005 Nov 17.
Clinical trial NCT05749718: Reliability and Validity of the Turkish Version of the Object Permanence Scale
Official title: Reliability and Validity of the Turkish Version of the Object Permanence Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Developmental Delay
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged 7-16 months with motor developmental delay

Brief summary: The aim of the study is the cultural adaptation of the Object Permanence Scale to Turkish and to examine its validity and reliability. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and after 1 week (retest). Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.


Eligibility criteria: Inclusion Criteria:

* 7-16 months,
* Sitting for at least 3 seconds but unable to independently switch between sitting and other positions
* To show at least one retardation in motor subscale of Bayley III.

Exclusion Criteria:

* Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Primary outcomes:
measure: Object Permanence Scale
timeFrame: Baseline
measure: Object Permanence Scale
timeFrame: After 1 week (retest)
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
timeFrame: Baseline
measure: Gross motor function measure sitting subscale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT03353818: Golf and Diabetes.
Official title: Golf and Diabetes Can an Introctionary Course to Golf and a Free 1-year Membership in a Golf Club Increase Physichal Activity?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice, Aarhus University
First posted: 2017-11-27
Enrollment: 45
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: This a randomised, single-blinded, controlled study that investigate if a free golf training programme will increase the physical activity of type 2 diabetes patients.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2-diabetes
* Physical activity less than 8000 steps per day
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Conditions that makes patients unfit for participation in golf

Primary outcomes:
measure: Physical activity
timeFrame: Evaluated at baseline and after 6 and 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: Evaluated at baseline and after 6 and 12 months
measure: Hand muscle strength
timeFrame: Evaluated at baseline and after 6 and 12 months
measure: Diabetic control
timeFrame: Evaluated at baseline and after 6 and 12 months
measure: Adherence
timeFrame: Evaluated at baseline and after 6 and 12 months
measure: Estimated VO2max
timeFrame: Evaluated at baseline and after 6 and 12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Public Health, Research Unit and Section of General Practice, University of Aarhus, ,
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital
Study officials:
References:
Clinical trial NCT01644318: CXCL9 and CXCL11 Levels in Patients With Autoimmune Thyroiditis and Habitual Abortions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Habitual Abortion
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-07-19
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Endocrinology Outpatient Clinic

Brief summary: The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with autoimmune thyroiditis and habitual abortions


Eligibility criteria: Inclusion Criteria:

* non-pregnant women with euthyroid autoimmune thyroiditis and a history of first trimester recurrent spontaneous abortions

Exclusion Criteria:

* 1) presence of acute or chronic systemic diseases; 2) other autoimmune diseases; 3) pregnancy and lactation over the previous 6 months; 4) evidence of infectious diseases in the last 3 months; 5) treatment with drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs, amiodarone, and lithium; 6) clinical history of hyperthyroidism and/or the presence of anti-TSH receptor antibodies.

Primary outcomes:
measure: Serum CXCL9 and CXCL11 levels in patients with autoimmune thyroiditis and habitual abortions
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Education and Research Hospital
Study officials:
References:
citation: Aktas A, Berberoglu Z, Fidan Y, Yazici AC, Koc G, Aral Y, Ademoglu E, Bekdemir H, Alphan Z. Higher levels of circulating CXCL-9 and CXCL-11 in euthyroid women with autoimmune thyroiditis and recurrent spontaneous abortions. Gynecol Endocrinol. 2014 Feb;30(2):157-60. doi: 10.3109/09513590.2013.871514. Epub 2013 Dec 19.
Clinical trial NCT01835418: Bedtime Administration of Amlodipine Versus Lisinopril
Official title: Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: managed with bedtime administration of lisinopril versus amlodipine
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 80
* Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.
* Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.

Exclusion Criteria:

* Current antihypertensive medication use
* Baseline GFR \< 45
* Preexisting macroproteinuria
* Chronic congestive heart failure
* History of CVA
* Diabetes Mellitus
* Pregnancy
* Night-shift work
* Other preexisting contraindication to amlodipine or lisinopril

Primary outcomes:
measure: Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril
timeFrame: 1 year
Secondary outcomes:
measure: Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP
timeFrame: 1 year
measure: Impact of individual medications on sleep-time blood pressure drop (dipping status)
timeFrame: 1 year
measure: Association of baseline renin levels to sleep-time blood pressure drop
timeFrame: 1 year
measure: Association of baseline renin levels with response to amlodipine versus lisinopril
timeFrame: 1 year
measure: Association of baseline dipping status with response to amlodipine versus lisinopril
timeFrame: 1 year
measure: Association of age and response to amlodipine versus lisinopril
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05163418: Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Official title: Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Flat Feet
High Arched Foot
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Cryos Technologies Inc.
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2021-12-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to validate a new non-invasive clinical imaging system to evaluate the efficacy of plantar orthotics and to assess the biomechanical efficiency of plantar orthotics for people with flat or high arch feet. The Cryovizion system should detect changes in participants' posture with an accuracy of 95%, while orthotics should improve the body's postural symmetry index.


Eligibility criteria: Inclusion Criteria:

* BMI\<30
* No pain
* No musculoskeletal disorders
* No balance disorders
* No pathologies linked to the central nervous system
* No use of drugs affecting the balance

Exclusion Criteria:

* People with foot pathology other than the arch;
* People with diabetes ;
* People with severe obesity ;
* People wearing high heel shoes regularly ;
* People with degenerative disease ;
* People with neuromuscular pathology ;
* People with a circulatory disorder ;
* People who have had major lower body surgery;
* Inability to walk 30 minutes continuously.

Primary outcomes:
measure: Change from baseline in body's postural symmetry index at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in body's postural symmetry index at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in body's postural symmetry index at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from baseline in flexion-extension angles of lower body joints during gait at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in flexion-extension angles of lower body joints during gait at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in flexion-extension angles of lower body joints during gait at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: TOPMED
state: Quebec
Study officials:
affiliation: TOPMED
name: Edith Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05738018: Evaluating Patient Experiences in Skin Care Clinical Studies
Official title: An Observational Study Analyzing Patient Experiences in Skin Care Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Skin Care
Keywords: Skin Care
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational skin care clinical trial, but have not yet completed enrollment and registration.

Brief summary: Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This trial will evaluate the safety and efficacy of new skin care products and treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future skin care studies.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
* Participants who are vulnerable to any intervention

Primary outcomes:
measure: Rate of patients who decide to enroll in a skin care clinical study.
timeFrame: 3 months
measure: Number of skin care study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Lichterfeld-Kottner A, El Genedy M, Lahmann N, Blume-Peytavi U, Buscher A, Kottner J. Maintaining skin integrity in the aged: A systematic review. Int J Nurs Stud. 2020 Mar;103:103509. doi: 10.1016/j.ijnurstu.2019.103509. Epub 2019 Dec 23.
citation: Lichterfeld A, Hauss A, Surber C, Peters T, Blume-Peytavi U, Kottner J. Evidence-Based Skin Care: A Systematic Literature Review and the Development of a Basic Skin Care Algorithm. J Wound Ostomy Continence Nurs. 2015 Sep-Oct;42(5):501-24. doi: 10.1097/WON.0000000000000162.
citation: Kottner J, Boronat X, Blume-Peytavi U, Lahmann N, Suhr R. The epidemiology of skin care provided by nurses at home: a multicentre prevalence study. J Adv Nurs. 2015 Mar;71(3):570-80. doi: 10.1111/jan.12517. Epub 2014 Aug 27.
Clinical trial NCT03890718: Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus
Official title: Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 38
Sex: ALL
Minimum age (years): 34
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.

Detailed description: Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) were divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures were pre- and postoperative uncorrected distance visual acuity (UDVA), best corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry.

Eligibility criteria: Inclusion criteria

* age 34 (range from 34 to 41)
* stable corneal topography and refraction for at least six months
* estimated residual bed thickness of \>410 µm

Exclusion

* presence of macular or retinal disease,
* dry eye
* history of recurrent corneal erosions
* anterior segment abnormalities
* unstable refractive error
* post-surgically residual stromal bed thickness of under 350 mm
* autoimmune disease
* collagen vascular disease
* immunosuppressive therapy or current use of systemic corticosteroids
* diabetes mellitus
* pregnancy
* lactation

Primary outcomes:
measure: visual acuity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Aberrometry properties by iTrace Ray-tracing aberrometry
timeFrame: 3 year
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Farideh Doroodgar
Study officials:
affiliation: Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
name: Jorge Alio, MD,PhD
role: STUDY_CHAIR
References: