louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02501200: CKD-391 Pharmacokinetic Study Phase I
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Dyslipidemia
CKD-391
Atorvastatin
Ezetimibe
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 46
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

Detailed description: To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Eligibility criteria: Inclusion Criteria:

* Bwt \>=50kg, BMI 18.5\~25
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* - Clinically significant disease
* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Clinically significant allergic disease
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: AUClast
timeFrame: up to 96 hours post dose
measure: Cmax
timeFrame: up to 96 hours post dose
Secondary outcomes:
measure: Tmax
timeFrame: up to 96 hours post dose
measure: T1/2
timeFrame: up to 96 hours post dose
measure: AUCinf
timeFrame: up to 96 hours post dose
measure: Adverse events
timeFrame: up to 24days post dose
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Choon Ok Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185900: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Official title: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor, Premature
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor


Eligibility criteria: Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

Primary outcomes:
measure: Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence
timeFrame: 48 hours after administration of study medication.
Secondary outcomes:
measure: Time to Uterine Quiescence
timeFrame: Until delivery, up to 42 weeks of gestation
measure: Gestational Age at Delivery
timeFrame: Until delivery, up to 42 weeks of gestation
measure: Neonatal Birth Weight
timeFrame: Until delivery, up to 42 weeks of gestation
measure: Serious Maternal Adverse Effect
timeFrame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
measure: Composite Neonatal Morbidity
timeFrame: From delivery until discharge from the hospital, up to 30 days of age
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35.
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT04834700: Comparison of Hands-on Versus Online Learning About Ocular Ultrasound
Official title: Comparison of Hands-on Versus Online Learning in Teaching Ultrasound Skills for Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergencies
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as coronavirus disease 19 (COVID19). As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.

Detailed description: Since the eye is an superficial organ, it has excellent access to ultrasound. Also, the eye has a liquid-filled structure (vitreous body), it is suitable for obtaining some important findings with bedside ultrasound. In patients who visit an emergency room with ocular symptoms, point-of-care ultrasound can quickly identify several emergency diseases. While training of eye ultrasound skills is useful for emergency physicians, hands-on education is risky in pandemic situation such as COVID19. As a solution to this, non-face-to-face education via online has been on the rise. The investigators hypothesized that even an online education is enough to perform basic eye ultrasound by emergency physician.

Eligibility criteria: Inclusion Criteria for doctors:

* Those who have received basic ultrasound education but have not received ocular ultrasound education
* Residents and interns working in the emergency room
* Those who voluntarily agree to participate in the research through the recruitment announcement

Inclusion Criteria for standard patients:

* Adults over 18 years of age without eye-related symptoms
* Those who do not have unusual findings in the eye when scanning by ultrasound
* Those who voluntarily agree to participate in the research through the recruitment announcement

Exclusion Criteria for standard patients:

* Those with a history of ophthalmic diseases
* Those who have a history of ophthalmic surgery such as lens implantation

Primary outcomes:
measure: scan score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Optic nerve sheath diameter (ONSD)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung medical center, Emergency department
name: Hee Yoon, MD., PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00240500: Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Official title: Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Long-term follow-up
Hepatitis B antibody persistence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 109
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Eligibility criteria: Inclusion Criteria:

* Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)
* Written informed consent obtained from each subject before each blood sampling visit

Primary outcomes:
measure: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
timeFrame: Years 17, 18, 19 and 20.
measure: Prevalence of Serological Markers for Hepatitis B Infection
timeFrame: Years 17, 18, 19 and 20.
measure: Clinical Review for Hepatitis B Infection Status
timeFrame: Over the entire 4 year follow up period (17 - 20 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, Jacquet JM. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011 May;18(5):369-75. doi: 10.1111/j.1365-2893.2010.01312.x.
citation: Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010 Jan 8;28(3):730-6. doi: 10.1016/j.vaccine.2009.10.074. Epub 2009 Nov 3.
Clinical trial NCT00612300: Gait Training for Persons With Stroke
Official title: The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Middle Cerebral Artery Infarction
Keywords: Ambulatory stroke patients
Gait training
Lokomat
Physical therapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 16
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: TREATMENT

Brief summary: The objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects.

Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more than categorized gait training.


Eligibility criteria: Inclusion Criteria:

1. First time Stroke
2. Middle cerebral artery infarction
3. Less than three month from stroke onset
4. Able to walk with or without a stick at gait speed less than 0.5 m/s
5. Participants are able to cope with the Lokomat

Exclusion Criteria:

1. Co-morbidity which impedes study participations
2. Language deficits which makes it impossible to understand oral or written study instructions
3. More than 190 cm tall and 135 kg in weight
4. Pregnancy
5. No gait function prior stroke
6. Skin sore or eruption on lower extremity or trunk, differences in lower extremity length of more than 2 cm or contracture of lower extremity which impedes gait training in the Lokomat -

Primary outcomes:
measure: 10 meters walking test (gait speed)
timeFrame: at inclusion, week 3 and week 6
Secondary outcomes:
measure: Six minutes walking test
timeFrame: Inclusion, wek 3 and week 6
measure: Gait symmetry index
timeFrame: Inclusion, week 3 and week 6
measure: Timed Up And Go
timeFrame: Inclusion, Week 3 and Week 6
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Center
Study officials:
affiliation: Hammel Neurorehabilitation and Research Center, Denmark
name: Jørgen F Nielsen, Professor
role: STUDY_CHAIR
affiliation: Hammel Neurorehabilitation and Research Center, Denmark
name: Carsten Kock-Jensen, MD
role: STUDY_DIRECTOR
affiliation: Hammel Neurorehabilitation and Reseach Center
name: John Brincks, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04501900: The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation
Official title: The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 2106
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 aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.


Eligibility criteria: Inclusion Criteria:

1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
2. Written informed consent from the subjects
3. Qualified candidates for coronary bypass surgery
4. Lesions with reference vessel diameter 2.75 to 3.5 mm

Exclusion Criteria:

1. Age ≤ 18 years
2. Cardiogenetic shock
3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%
4. Oral anticoagulation therapy
5. Known allergy or intolerance to the study medications
6. Malignancies and other comorbid conditions with a life expectancy less than 5 years
7. Subjects treated with both BRS and DES during the index procedure
8. Pregnant wowen
9. Planned staged PCI
10. Contemporaneous enrollment in a different clinical trial
11. Any revascularization within 1 year
12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
13. Unprotected left main artery
14. Lesions located at the ostium of the main coronary artery
15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy

Primary outcomes:
measure: MACE
timeFrame: 3 years
measure: BARC type 3, 4, and 5 bleeding events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00310700: Kinetics of B Cell Response in Infants Menjugate Vaccination
Official title: A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prevention of Meningococcal Infection
Keywords: Prevention of Meningococcal Meningitis
vaccines, conjugate
immunology
infant
antibody persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-04
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Kinetics of B cell response in infants Menjugate vaccination


Eligibility criteria: Inclusion Criteria:

* healthy infants

Exclusion Criteria:

* previously ascertained or suspected disease caused by N. meningitidis
* previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Primary outcomes:
measure: To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
Secondary outcomes:
measure: To establish how long the B cells persist in the blood
measure: To note the difference between plasma cell response following the first and third MenC vaccination.
measure: To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
state: Oxon
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Information Services
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x.
Clinical trial NCT00486200: A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
Official title: A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Genitalis
Keywords: ASP2151
Herpes Genitalis
Sexually Transmitted Disease
Herpes Simplex Virus Genital Infection
Treatment Outcome
Genital Herpes
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 695
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: A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.


Eligibility criteria: Inclusion Criteria:

* Subject has a history of genital HSV documented by laboratory testing at screening
* Subject has experienced 4 or more episodes of genital herpes during the past 12 months

Exclusion Criteria:

* Subject is immunocompromised

Primary outcomes:
measure: To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
timeFrame: 17 days
Secondary outcomes:
measure: Pharmacokinetics in study patients
timeFrame: 4 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Madisonville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Annandale
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20.
Clinical trial NCT03426800: Acupuncture - a Treatment for Children With Headache
Official title: Acupuncture - a Treatment for Children With Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Headache
Keywords: Acupuncture
Training
Children
Effect
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2018-02-08
Enrollment: 3
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupuncture as a treatment for headache in children

Detailed description: A randomised controlled study in the effect of acupuncture as a treatment for headache in children.

The children are randomised for training or for training and acupuncture.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by pediatrician-
* Age-9-17 years
* Min. headache 8 times within the last month

Exclusion Criteria:

* Mentally illness
* Fear of needles

Primary outcomes:
measure: Days with headache
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: North Denmark Hospital
Study officials:
References: