louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03254251: The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
Official title: The Effects of a 12-week Stair Climbing Regimen on Arterial Stiffness, BP and Leg Strength in Stage-1 Hypertensive Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Menopause
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Dong-Eui University
name: University of Nebraska
First posted: 2017-08-18
Enrollment: 41
Sex: FEMALE
Minimum age (years): 58
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. SC training session was progressive program, and was performed 4 days a week for 12 weeks. Measurements were collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48 and 72 hours after the last exercise session.


Eligibility criteria: Inclusion Criteria:

* Stage-1 hypertension
* Postmenopausal

Exclusion Criteria:

* Pulmonary, renal, adrenal, pituitary, severe psychiatric, thyroid, or cardiovascular disease other than stage-1 systolic hypertension (140-159 mmHg)
* Hormone replacement therapy during the 6 months prior the study
* Smoker or having any medication changes in the previous year
* Experience with psychological and physical therapy in the previous year
* History of steady exercise or exercise training in the last year

Primary outcomes:
measure: Arterial stiffness
timeFrame: 12 weeks
measure: Blood pressure (BP)
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Heart rate (HR)
timeFrame: 12 weeks
measure: Body mass index (BMI)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wong A, Figueroa A, Son WM, Chernykh O, Park SY. The effects of stair climbing on arterial stiffness, blood pressure, and leg strength in postmenopausal women with stage 2 hypertension. Menopause. 2018 Jul;25(7):731-737. doi: 10.1097/GME.0000000000001072.
Clinical trial NCT01889251: A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Official title: A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Vitreomacular Adhesion
Keywords: Vitreomacular Adhesion
Vitreomacular Traction
Vitreomacular Traction Syndrome
Vitrectomy
Central Visual Field Defect
Blind Spot
Intravitreal Injection
Macula
Retina
Decreased Visual Acuity
Visual Complaint
SD-OCT
Macular Hole
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 251
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.


Eligibility criteria: Inclusion Criteria:

* Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
* Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
* BCVA of 20/800 or better in the non-study eye;
* Provide written informed consent;
* Follow specified instructions during study period;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
* Vitreous hemorrhage or other opacification;
* High myopia in the study eye;
* Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
* Uncontrolled glaucoma in the study eye;
* History of retinal detachment in either eye;
* Active infection in either eye;
* Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
* Participation in another investigational drug study within 30 days prior to this study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Group Manager, Clinical Development
role: STUDY_DIRECTOR
References:
Clinical trial NCT00382551: The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
Official title: The Effect of Alcohol and Polyphenolic Compounds on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronary Heart Disease
Keywords: Alcohol
Red wine
Endothelial function
Flow-mediated vasodilation
Cardiovascular disease
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2006-09-29
Enrollment: 49
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.


Eligibility criteria: Inclusion Criteria:

* Men or postmenopausal women with stable coronary heart disease
* Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.

Exclusion Criteria:

* Patients with myocardial infarction within the last tree months
* Persons with a present or earlier alcohol abuse
* Persons with a present or earlier drug abuse
* Person with malign disease
* Persons, that we consider unsuitable to carry through the examines.

Primary outcomes:
measure: Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
Secondary outcomes:
measure: Lipid status after 2 weeks intervention compared with baseline
measure: Effects in Coagulation factors after 2 weeks intervention
measure: Effects on markers of inflammation after 2 weeks intervention
measure: Effects on markers of endothelial function after 2 weeks intervention
measure: Changes in the overall antioxidant activity in plasma after 2 weeks intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Cardiology, Aalborg Hospital, Science and Innovation Center
Study officials:
affiliation: Department of Cardiology, Aalborg Hospital , Aarhus University Hospital
name: Erik B Schmidt, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04955951: Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
Official title: Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Atopic Dermatitis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Patient will be referred to physical therapy outpatient clinic, faculty of physical therapy, Ahram Canadian University from dermatology out-clinics in Sheikh Zayed Hospital.

Brief summary: Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood.

Detailed description: Polarized ultraviolet-free polychromatic light is used as therapeutic option for the treatment of wound healing and dermatological conditions.

40 male patients who had atopic dermatitis in the chronic stage, they were complaining from itching, inflammation and skin thickness in the arm, wrist, hand and leg will participate in this study.

Eligibility criteria: Inclusion Criteria:

* The patients' ages will ranged from 20 to 30 years.
* The subjects will be males.
* The duration of disease less than 1 year.

Exclusion Criteria:

* patients who had skin malignancy in the area to be treated.
* The patients who had history of diabetes, circulatory or sensory disorders.
* Patients with acute infection in the area treated.

Primary outcomes:
measure: Ultrasonography
timeFrame: 1-2 months
Secondary outcomes:
measure: SCORAD Score
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram Canadian University
Study officials:
References:
Clinical trial NCT04720651: Calf Muscle Tightness in Flat Foot Subjects
Official title: Prevalence of Calf Muscle Tightness in Asymptomatic Flat Foot Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flat Feet
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with flexible flat foot aged between 20 and 40 years old . They should have navicular drop more than 10 mm and their body mass index is between 18.5 kg/m2 to 29.9 kg/m2.

Brief summary: The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.

Detailed description: Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot.

A flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone.

Up to our knowledge:

1. No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association.
2. And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot.

Consequently this study is conducted.

Eligibility criteria: Inclusion Criteria:

1. Subjects should have flexible flat foot.
2. Age between 20 and 40 years.
3. Navicular drop of more than 10 mm.
4. Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2.
5. Subjects will sign the written consent form after the aim and methods of the study are explained clearly.

Exclusion Criteria:

1. Subjects with history of foot and ankle surgery, trauma, fracture or dislocation.
2. Subjects with congenital deformities in the ankle and foot.
3. Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.

Primary outcomes:
measure: tightness of the calf muscle
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Meehan RE, Brage M. Adult acquired flat foot deformity: clinical and radiographic examination. Foot Ankle Clin. 2003 Sep;8(3):431-52. doi: 10.1016/s1083-7515(03)00019-6.
citation: Tome J, Nawoczenski DA, Flemister A, Houck J. Comparison of foot kinematics between subjects with posterior tibialis tendon dysfunction and healthy controls. J Orthop Sports Phys Ther. 2006 Sep;36(9):635-44. doi: 10.2519/jospt.2006.2293.
citation: Van Boerum DH, Sangeorzan BJ. Biomechanics and pathophysiology of flat foot. Foot Ankle Clin. 2003 Sep;8(3):419-30. doi: 10.1016/s1083-7515(03)00084-6.
Clinical trial NCT04277351: Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
Official title: Role of Auditory Cortical Oscillations in Speech Processing and Its Dysfunction in Dyslexia Through Transcranial Alternating Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: Wyss Center for Bio and Neuroengineering
First posted: 2020-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at investigating the role of low-gamma activity in phonemic encoding and its implication in dyslexia. Indeed, a phonological deficit, i.e. a difficulty in perceiving the sounds of speech, is strongly suspected in dyslexia but has never been conclusively associated with a specific underlying mechanism.

The study employs transcranial alternating current stimulation in adults with and without dyslexia to exploit the effect of the stimulation on phonemic processing and neural activity measured with electroencephalography. In doing so, it would be possible to establishing a causal link between gamma oscillations and the phonological deficit in dyslexia.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old;
* French native speakers;
* normally-hearing;
* intellectual quotient (IQ) around average;
* for the dyslexia group: previous diagnosis of dyslexia as assessed by a speech therapist.

Exclusion Criteria:

* Presence of metal or electronic implants in the brain/skull;
* Presence of metal or electronic device at other in other parts of the body;
* Have experienced a seizure or a loss of consciousness or a severe head trauma;
* Severe brain related illness ;
* Intake of central nervous system-effective medication;
* Pregnant and nursing women;
* Relatives affected by epilepsy.

Primary outcomes:
measure: Measure low-gamma neural oscillations with electroencephalography recordings
timeFrame: 6 hour
measure: Changes in linguistic performance through a battery of behavioral tests
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Campus Biotech Geneva
Study officials:
affiliation: University of Geneva
name: Anne-Lise Giraud, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehongre K, Ramus F, Villiermet N, Schwartz D, Giraud AL. Altered low-gamma sampling in auditory cortex accounts for the three main facets of dyslexia. Neuron. 2011 Dec 22;72(6):1080-90. doi: 10.1016/j.neuron.2011.11.002.
Clinical trial NCT03817151: Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support
Official title: Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Absence of Capsule Support
Aphakia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent transscleral sutured PCIOL implantation between January 2017 and August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Brief summary: To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent transscleral suture fixation of PCIOL
2. Time between the primary surgeries was at least 3 months

Exclusion Criteria:

1. Active intraocular inflammation
2. The intraocular pressure (IOP) was higher than 25 mmHg
3. The endothelial cell count (ECC) was more than 1,200 cells/mm2

Primary outcomes:
measure: Visual function
timeFrame: 1day postoperation
measure: Visual function
timeFrame: 1 week postoperation
measure: Visual function
timeFrame: 1 month postoperation
measure: Visual function
timeFrame: 3 month postoperation
measure: Visual function
timeFrame: 1 day postoperation
measure: Visual function
timeFrame: 1 week postoperation
measure: Visual function
timeFrame: 1 month postoperation
measure: Visual function
timeFrame: 3 month postoperation
Secondary outcomes:
measure: intraocular pressure
timeFrame: 1 day, 1 week, 1 month, and 3 month postoperation
measure: PCIOL tilt degree
timeFrame: 3 month postoperation
measure: PCIOL decentration degree
timeFrame: 3 month postoperation
measure: endothelial cell count
timeFrame: 1 week, 1 month, and 3 month postoperation
measure: anterior chamber depth
timeFrame: 3 month postoperation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00398151: To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
Official title: An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.


Eligibility criteria: Inclusion Criteria:

* Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
* Male or female outpatient 20 years of age and older
* Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

* Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
* Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
* Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
* Treated with montelukast within 3 months before enrollment
* Unable to perform acceptable, reproducible spirometry and peak flow measurement
* Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

Primary outcomes:
measure: Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
Secondary outcomes:
measure: Asthma symptoms score throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02029651: Effects of Novel Game Rehabilitation System on Upper Extremity Function of Patients With Stroke
Official title: Effects of Novel Game Rehabilitation System (E-glove System) on Upper Extremity Function of Patients With Stroke :Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand
Rehabilitation
Game
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
name: National IT Industry Promotion Agency, Republic of Korea
First posted: 2014-01-08
Enrollment: 59
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: The purpose of this study is to determine whether novel upper extremity rehabilitation system for patients with stroke(e-glove system) are effective in the rehabilitation compared to conventional occupational therapy


Eligibility criteria: Inclusion Criteria:

* Hemiplegic stroke patients
* Medical research council scale \>= 2 of finger or wrist flexor/extensor
* Medical research council scale \>= 2 of elbow pronation/supination

Exclusion Criteria:

* Bilateral weakness of upper extremities
* Uncontrolled medical or surgical illness
* Predisposing psychological or neurological disorders
* Severe aphasia unable to communicate
* Severe cognitive impairment not to cooperate
* Severe pain impeding upper extremity rehabilitation

Primary outcomes:
measure: Fugl-meyer assessment_upper extremity
timeFrame: Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention
Secondary outcomes:
measure: Fugl-meyer assessment_upper extremity
timeFrame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
measure: Jebsen hand function test
timeFrame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
measure: Purdue pegboard
timeFrame: Baseline, after 10th intervention, after 20th intervention, 1 month after intervention
measure: Stroke impact scale
timeFrame: Baseline, after 20th intervention
measure: Modified Ashworth scale of affected upper extremity
timeFrame: Baseline, after 20th intervention
measure: Medical research council scale of muscle strength of affected upper extremity
timeFrame: Baseline,after 20th intervention
measure: Satisfaction about intervention
timeFrame: after 20th intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.