louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01198093: Clinical Research Center for Dementia of South Korea (CREDOS)(or CRCD)
Official title: Clinical Research Center for Dementia of South Korea (CREDOS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Mild Cognitive Impairment
cohort study
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2010-09-09
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patient populatin who is suffering from memory impairment
2. Normal subjects matched with age and gender

Brief summary: The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea

Detailed description: The specific aims of this study is (1) construction \& maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral \& CSF markers, neuroimaging(both structural \& functional)

Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study.

  1. the diagnostic criteria of Alzheimer's disease(AD) according to DSM IV or NINCDS -ADRDA
  2. the diagnostic criteria of mild cognitive impairment(MCI) A. Memory or other cognitive complaint preferably corroborated by an informant B. Objective memory impairment or other cognitive for age and education C. Largely intact general cognitive function D. Essentially preserved ADL E. Not demented

Exclusion Criteria:

* Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Kangnam-Ku
Study officials:
affiliation: Ministry of Health and Welfare
name: Doh K KIm, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YM, Park JM, Lee BD, Moon E, Jeong HJ, Chung YI, Kim JH, Kim HJ, Mun CW, Kim TH, Kim YH. Gray matter volumes and treatment response of psychotic symptoms to risperidone in antipsychotic-naive Alzheimer's disease patients. J Clin Psychiatry. 2016 Jan;77(1):e8-13. doi: 10.4088/JCP.14m09740.
citation: Yoon B, Shim YS, Cheong HK, Hong YJ, Lee KS, Park KH, Ahn KJ, Kim DJ, Kim YD, Choi SH, Yang DW. White matter hyperintensities in mild cognitive impairment: clinical impact of location and interaction with lacunes and medial temporal atrophy. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):e365-72. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.040. Epub 2014 Feb 28.
Clinical trial NCT03839693: ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Lead sponsor: Eirion Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 75
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: sequential cohort, dose escalating study
Primary purpose: TREATMENT

Brief summary: This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed description: This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Eligibility criteria: Inclusion Criteria:

* females 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet on contraction
* adequate vision to assess facial wrinkles in a mirror
* willingness to refrain from products affecting skin remodeling
* female subjects must be not pregnant and non-lactating
* subjects should be in good general health

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
timeFrame: Week 1, 2, 4, 8,12,18, and 26
measure: Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12
timeFrame: Week 4, 8,and 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Pinellas Park
country: United States
facility: Synexus, Inc.
state: Florida
city: Louisville
country: United States
facility: Forefront Dermatology
state: Kentucky
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
References:
Clinical trial NCT00347893: The Efficacy of Selective Laser Trabeculoplasty
Official title: Clinical Results of Selective Laser Trabeculoplasty in Treatment of Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Pseudo-Exfoliative Glaucoma
Pigment Dispersion Glaucoma
Keywords: Primary open angle glaucoma
Ocular hypertension
Pseudo-exfoliative glaucoma
Pigment Dispersion glaucoma
selective laser trabeculoplasty
intraocular pressure
Lead sponsor: Glaucoma Research & Education Group
Sponsor class: OTHER
Collaborators: name: PharmaLogic Development, Inc.
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Selective laser trabeculoplasty (SLT) is a new method to reduce intraocular pressure in eyes with open angle glaucoma or ocular hypertension. SLT may also be effective for cases with previously failed ALT procedures. We will study the efficacy and safety of the SLT procedure.

Detailed description: Selective laser trabeculoplasty (SLT) has been shown to be a safe, well tolerated, and effective intraocular pressure reduction therapy for several forms of open-angle glaucoma. SLT produces significantly less disturbance to the trabecular meshwork and is theoretically more repeatable than the ALT procedure. This retrospective research will begin with cases treated in 2001. It will evaluate whether SLT is effective for patients who have had prior treatment with ALT and it will determine whether the IOP lowering effect is sustainable over time. It will also assess the efficacy of repeated SLT procedures.

Eligibility criteria: Inclusion Criteria:

* Patients with primary open angle glaucoma, ocular hypertension, pseudo exfoliative glaucoma, pigment dispersion glaucoma

Exclusion Criteria:

* History of prior invasive glaucoma surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Glaucoma Center of San Francisco
state: California
Study officials:
affiliation: Glaucoma Research & Education Group
name: Andrew G. Iwach, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544593: The Volumetric Analysis of Fat Grafting
Official title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autologous Fat Grafting
Lead sponsor: Hunstad Kortesis Bharti Cosmetic Sugrery
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2018-06-04
Enrollment: 50
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: OTHER

Brief summary: Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.

Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.


Eligibility criteria: Inclusion Criteria:

1. Females or Males in good general health age 18 - 65 years of age
2. Must be willing to give and sign a HIPAA form and informed consent form
3. Must be willing and able to comply with all study protocols and schedules
4. Negative urine pregnancy test prior to surgery treatment (if applicable)
5. The patient must have had a stable weight (no fluctuation of \>15 pounds in a year), diet, and physical activity for the previous 6 months

Exclusion Criteria:

1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
2. History of breast cancer if fat grafting to breasts
3. Patients who smoke or use nicotine products
4. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
5. Diabetes Mellitus
6. Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery
7. Patients under the age of 18
8. Patients undergoing fat grafting but refuse enrollment
9. Patients with an active infection
10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Primary outcomes:
measure: Graft retention
timeFrame: 9 months
Secondary outcomes:
measure: Volume of adipose harvested (mL)
timeFrame: Intra Op
measure: Volume of adipocyte injected (mL)
timeFrame: Intra Op
measure: Operating room time (harvesting, processing, and reinjection time) (min)
timeFrame: Intra Op
measure: Standardized before and after photos
timeFrame: Pre op, 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: Huntersville
country: United States
facility: Kelly Costin
state: North Carolina
Study officials:
affiliation: Hunstad Kortesis Bharti Cosmetic Surgery
name: Kelly Costin, RN, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01862393: Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
Official title: The Influence of Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Torque
Pain Perception
Keywords: electrical stimulation
torque
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.


Eligibility criteria: Inclusion Criteria:

* sedentary healthy university students.

Exclusion Criteria:

* history of knee surgery or injury,
* musculoskeletal, cardiovascular or neurological disease including impaired sensation.

Primary outcomes:
measure: Torque
timeFrame: During 4 seconds of electrical stimulation
Secondary outcomes:
measure: Discomfort
timeFrame: During 6 seconds of electrical stimulation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Cidade de São Paulo
state: SP
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Richard E Liebano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951193: Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents
Official title: Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Depression
Adolescent Behavior
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-07-06
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team to assist with quitting vaping. Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 4 weeks.


Eligibility criteria: Inclusion Criteria:

1. age 16-20
2. vaped nicotine on ≥20 days out of the last 30
3. elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
4. currently own an iOS or Android smartphone
5. report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
6. have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
7. ability to read the consent form
8. has been seen (in person or remotely) by a primary care physician within the last year

Exclusion Criteria:

1. smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
2. severe visual impairment
3. currently receiving treatment for vaping or tobacco use
4. current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
5. household member currently enrolled in the study
6. inability to read the consent form

Primary outcomes:
measure: Mean Score of Depressive Symptoms
timeFrame: Up to 4 weeks
measure: Average Vapes Per Day at Week 4
timeFrame: Week 4
measure: E-cigarette Dependence
timeFrame: Up to 4 weeks
measure: Number/Duration of Quit Attempts
timeFrame: Across all 4 weeks
measure: 7-day Point Prevalence Abstinence
timeFrame: At any point during the study
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer Dahne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823393: Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
Official title: Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aortic Stenosis, Non-rheumatic
Keywords: balloon aortic valvuloplasty indication
heparin
hemorrhagic
ischemic
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 94
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: To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.


Eligibility criteria: Inclusion Criteria:

* be over 18
* carry a tight and symptomatic aortic stenosis
* have an indication for a ballon aortic valvuloplasty
* Subject have signed his written informed consent

Exclusion Criteria:

* Have an absence of femoral surgical approach
* have a criticial hemodynamic state, considered as outdrove for the treatment
* have a severe aortic failure
* allergia to heparin
* contraindication to heparin or/and local anaesthetic
* be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty
* have a tight but not symptomatic aortic stenosis

Primary outcomes:
measure: Number of serious complication : vascular, hemorrhagic or ischaemic complication
timeFrame: Up to10 days after the valvuloplasty (D1-D10 after the intervention)
Secondary outcomes:
measure: Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)
timeFrame: up to30 days after the valvuloplasty (until D30 after intervention)
measure: number of a serious complication : vascular, hemorrhagic or ischaemic complication
timeFrame: up to 30 days after valvuloplasty
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: UH Montpellier
name: Florence Leclercq, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00570193: Photodynamic and Pharmacologic Treatment of CNV
Official title: Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Choroidal Neovascularization
Macular Degeneration
Lead sponsor: Mid-Atlantic Retina Consultations, Inc.
Sponsor class: OTHER
First posted: 2007-12-10
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.


Eligibility criteria: Inclusion Criteria:

* All previously untreated CNV secondary to MD

Primary outcomes:
measure: Visual change
timeFrame: 18 months
Secondary outcomes:
measure: Frequency of treatment
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Mid-Atlantic Retina Consultations
name: Nabil M Jabbour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256593: Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
Official title: DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuralgia
Keywords: Lyrica
Regulatory Post Marketing Commitment Plan
Safety
Neuropathic Pain
Post Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 3827
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.

Brief summary: The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Detailed description: All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Lyrica®.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reaction
timeFrame: 13 weeks at maximum
Secondary outcomes:
measure: Percentage of Participants With Serious Adverse Drug Reaction
timeFrame: 13 weeks at maximum
measure: The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert
timeFrame: 13 weeks at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events
timeFrame: 13 weeks at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury
timeFrame: 13 weeks at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Vision-related Events
timeFrame: 13 weeks at maximum
measure: Clinical Effectiveness Rate
timeFrame: At Week 13
measure: Change From Baseline in Participant-rated Pain Score at Week 13
timeFrame: Baseline and at Week 13
measure: Change From Baseline in Participant-rated Sleep Interference Score at Week 13
timeFrame: Baseline and at Week 13
measure: Patient's Impression (PGIC) at Week 13
timeFrame: At Week 13
measure: Physician's Impression (CGIC) at Week 13
timeFrame: At Week 13
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: