louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03529240: Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
Official title: Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance
Energy
Gait
Duchenne Muscular Dystrophy
Keywords: kinesiology taping
performance
energy consumption
gait
Duchenne Muscular Dystrophy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 45
Sex: MALE
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics in patients with Duchenne Muscular Dystrophy

Detailed description: Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study. Performance was assessed by measuring the distance in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption by Physiological Consumption Index (PCI), and gait characteristics by footprint method on powdered ground at baseline. Kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application. The comparison between before and after taping was analyzed.

Eligibility criteria: Inclusion Criteria:

* Duchenne Muscular Dystrophy diagnosis,
* age 5 to 14 years,
* able to cooperate with instructions of physiotherapist,
* able to walk independently,
* climb 4 steps independently/with minimal support from handrails.

Exclusion Criteria:

* severe contracture at lower extremities,
* other disease except for DMD, and
* history of any injury or orthopaedic/neurologic surgery within the past 6 months.

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: 6 minute
Secondary outcomes:
measure: Energy Consumption
timeFrame: 6 minutes
measure: Gait
timeFrame: 2 minutes
measure: Timed Performance Test
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Güllü Aydın, R.A
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: İpek Alemdaroğlu Gürbüz, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Öznur Yılmaz, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ayşe Karaduman, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Numan Bulut, R.A
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Haluk Topaloğlu, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06772740: Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma
Official title: Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endovascular Treatment
Chronic Subdural Hematoma
Lead sponsor: Hyogo Medical University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 600
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: COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18
2. pre-mRS 0-3
3. Hematoma thickness \>=10mm
4. Having at least one risk factor Risk factor: Age \>=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score \>3, Preoperative volume \>=130ml, Preoperative midline shift \>=8mm, CT appearance (Homogeneous, laminar or separated)

Exclusion Criteria:

1. Cr \>=1.8
2. Plt \<50,000, PT-INR \>2
3. Life expectancy \<6 months

Primary outcomes:
measure: Rate of recurrence of chronic subdural hematoma
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo Medical University
state: Hyogo
Study officials:
References:
Clinical trial NCT00731640: Contralateral ReSTOR / Monofocal or Phakic Eye
Official title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Keywords: AcrySof
ReSTOR
Multifocal
Intraocular Lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.


Eligibility criteria: Inclusion Criteria:

* Unilateral operable cataract
* Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

* Ocular comorbidities compromising primary outcome
* Bilateral cataracts

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Contrast Sensitivity
timeFrame: 6 Months
measure: Patient Satisfaction
timeFrame: 6 Months Postoperative
measure: Spectacle Independence
timeFrame: 6 Months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04487340: Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
Official title: Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Keywords: thrombolysis
thrombectomy
hospitalization
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shaoxing People's Hospital
name: Affiliated Hospital of Jiaxing University
name: Huzhou Center Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: Jinhua Center Hospital
name: Taizhou Hospital
First posted: 2020-07-27
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acute stroke patients who were admitted to hospital.

Brief summary: In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.

Detailed description: This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.

Eligibility criteria: Inclusion Criteria:

Acute stroke patients

Exclusion Criteria:

No

Primary outcomes:
measure: Independence (mRS 0-2) at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality at 1 year
timeFrame: 1 year
measure: Brain hemorrhage at 24-72 hours after hospitalization
timeFrame: 72 hours
measure: The incidence of recurrent stroke or other vascular events at 1 year
timeFrame: 1 year
measure: Independence (mRS 0-2) at 5 year
timeFrame: 5 year
measure: The incidence of recurrent stroke or other vascular events at 5 year
timeFrame: 5 year
measure: All-cause mortality at 5 year
timeFrame: 5 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Min Lou
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Lou, PhD
role: STUDY_DIRECTOR
References:
citation: Wang J, Zhang J, Gong X, Zhang W, Zhou Y, Lou M. Prediction of large vessel occlusion for ischaemic stroke by using the machine learning model random forests. Stroke Vasc Neurol. 2022 Apr;7(2):94-100. doi: 10.1136/svn-2021-001096. Epub 2021 Oct 26.
Clinical trial NCT03212040: 14 g vs. 16 g in Breast Biopsy
Official title: Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Biopsy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 14 vs 16 gauge needles
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years
* Informed consent available
* Palpable and non-palpable breast findings
* Tumor size 5-20 mm
* Findings of sonographic BI-RADS® classification 2-5.
* Guideline-oriented indication for bioptic clarification

Exclusion Criteria:

* No reliable sonographic demarcation of the finding
* Pregnancy

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
measure: Diagnostic quality
timeFrame: 1 year
Secondary outcomes:
measure: Pain related to the biopsy procedure
timeFrame: 1 year
measure: Duration time of the biopsy procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Women's Health
Study officials:
References:
Clinical trial NCT00599040: The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
Official title: The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Hypertension
Insulin Resistance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-01-23
Enrollment: 113
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight


Eligibility criteria: Inclusion Criteria:

* African American adults (age ≥ 19)
* Obese (BMI \> or equal to 30 kg/m2)
* Otherwise generally healthy

Exclusion Criteria:

* Diagnoses of diabetes
* Malignancy or other states where weight loss is contraindicated (pregnancy
* Individuals with high blood pressure on medications.

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Nutrition Sciences Department
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104401: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
Official title: Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Ferrell Family Charitable Foundation
First posted: 2014-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
* Age \>= 18 years

Exclusion Criteria:

* Skull defect at or near site of tDCS delivery.
* History of a significant stroke or traumatic brain injury.
* History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
* Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
* Presence of ferrous metal in the head (except titanium; for instance shrapnel)
* History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)
* Pregnancy

Primary outcomes:
measure: Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
timeFrame: 16 weeks
Secondary outcomes:
measure: Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Fernando Pagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216201: Clinical Utility of SUDOSCAN in the Pediatric Population
Official title: Clinical Utility of SUDOSCAN in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Childhood Obesity
Prediabetes
Diabetes
Lead sponsor: Impeto Medical
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 subjects will be recruited by age group, with approximately 10 subjects representative of each age between 8 and 17. Both lean and obese subjects will be included from University of Southern California's Childhood Obesity Research Center (CORC).

Brief summary: The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.

Primary Objective: To measure sweat gland function in a pediatric population

Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population


Eligibility criteria: Inclusion Criteria:

* Males and females ages 8 to 17 years
* Able to give assent as well as parental consent

Exclusion Criteria:

* History of type 1 or type 2 diabetes
* Chronic autoimmune condition
* Taking chronic immunosuppressive or anti-inflammatory medications
* Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
* Presence of hepatitis B or C
* Presence of HIV
* Presence of known neurological disorder
* Pregnancy and/or breastfeeding
* Any open wound on the soles of the feet or palms of the hands
* Participation in an ongoing clinical investigational drug trial
* Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study

Primary outcomes:
measure: Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California's Childhood Obesity Research Center (CORC)
state: California
Study officials:
References:
citation: Muller G, Olschewski J, Stange T, Hjellset VT, Bornstein S, Schwarz PE. Non-invasive screening of diabetes risk by assessing abnormalities of sudomotor function. Exp Clin Endocrinol Diabetes. 2015 Jan;123(1):34-8. doi: 10.1055/s-0033-1357128. Epub 2014 May 5.
citation: Muller G, Parfentyeva E, Olschewsky J, Bornstein SR, Schwarz PE. Assessment of small fiber neuropathy to predict future risk of type 2 diabetes. Prim Care Diabetes. 2013 Dec;7(4):269-73. doi: 10.1016/j.pcd.2013.08.001. Epub 2013 Sep 27.
citation: Chen L, Chen X, Ding R, Shi Q Jr, Hu D. Evaluation of EZSCAN as a screening tool for impaired glucose metabolism. Diabetes Res Clin Pract. 2013 May;100(2):210-4. doi: 10.1016/j.diabres.2013.03.001. Epub 2013 Mar 22.
Clinical trial NCT04493801: Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap
Official title: Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery--Complications
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergoing a pituary gland surgery

Brief summary: Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap


Eligibility criteria: Inclusion Criteria:

* to be over 18 years old
* to be operated on for pituitary surgery
* to have express no objection to the study

Exclusion Criteria:

* refusal to participate in the study
* pregnant women
* to be Under the age of 18
* not being able to understand and accept participation in the study
* to have a life expectancy of less than a year

Primary outcomes:
measure: post operative epistaxis
timeFrame: during two month after surgery
measure: post operative rhinoliquorrhea
timeFrame: during two month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03321201: Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Official title: Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pterygium of Conjunctiva and Cornea
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital of Split
First posted: 2017-10-25
Enrollment: 164
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: Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with ﬁbrin glue for conjunctival autografting in primary pterygium surgery.


Eligibility criteria: Inclusion criteria:

* adults (older than 18 years of age)
* both sexes
* primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons
* if the patients had a bilateral pterygium, only one eye will be operated

Exclusion criteria:

* connective tissue disease
* prior eye surgery
* chronic use of topical drugs (anti-glaucoma drugs)

Primary outcomes:
measure: Recurrence of pterygium
timeFrame: 180 days
Secondary outcomes:
measure: Surgical time
timeFrame: During the surgery
measure: Complication rate
timeFrame: 7, 30 and 180 days
measure: Pterygium-induced astigmatism
timeFrame: 7, 30 and 180 days
measure: Ocular surface condition
timeFrame: 7, 30 and 180 days
measure: Postoperative discomfort, tearing, pain and foreign body sensation
timeFrame: 7, 30 and 180 days
measure: Pain
timeFrame: 7, 30 and 180 days
measure: Economic Analysis
timeFrame: 180 days
measure: Flap time
timeFrame: During the surgery
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
Study officials:
References:
citation: Lesin M, Paradzik M, Marin Lovric J, Olujic I, Ljubic Z, Vucinovic A, Bucan K, Puljak L. Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e020714. doi: 10.1136/bmjopen-2017-020714.