louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01514019: An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
Official title: An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: SLCO2B1 genotype
effect of apple juice
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Oita University
name: Seoul National University Hospital
name: Kyushu University
First posted: 2012-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C\>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers


Eligibility criteria: Inclusion Criteria:

* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

Exclusion Criteria:

* A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Primary outcomes:
measure: AUC of acebutolol according to the SLCO2B1 genotypes
timeFrame: 0-24 hr after drug administration
Secondary outcomes:
measure: Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes
timeFrame: 0-24 hr after drug admnistration
Other outcomes:
Locations:
city: Oita
country: Japan
facility: General Clinical Research Center, Oita University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
name: Kyoichi Ohashi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06892119: Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation
Official title: Dose-reduced Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Patients with Lymphoma and Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Myeloma
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study comparing placebo vs generic plerixafor
Primary purpose: OTHER

Brief summary: Generic plerixafor use at reduced-dose for mobilization on HSCT transplant

Detailed description: The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.

Eligibility criteria: Inclusion Criteria:

* Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
* Patients \> 18 years old who signed our informed consent
* Normal CBC count (Hb \> 10, WBC 4.0-11.00, plt \> 100,000)

Exclusion Criteria:

* Patients with HIV, Hepatitis C, Hepatitis B diagnosis
* Pregnant women

Primary outcomes:
measure: Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Universidad Autónoma de Nuevo León
state: Nuevo Leon
Study officials:
affiliation: Universidad Autónoma de Nuevo León
name: Olga G Cantú-Rodríguez, MD
role: STUDY_CHAIR
References:
citation: Gutierrez-Aguirre CH, Alvarado-Navarro DM, Palomares-Leal A, Mejia-Jaramillo G, Salazar-Riojas R, Leon AG, Colunga-Pedraza PR, Sotomayor-Duque G, Jaime-Perez JC, Cantu-Rodriguez OG, Del Carmen Tarin-Arzaga L, Flores-Jimenez JA, Gomez-Almaguer D. Reduced-dose plerixafor as a mobilization strategy in autologous hematopoietic cell transplantation: a proof of concept study. Transfusion. 2019 Dec;59(12):3721-3726. doi: 10.1111/trf.15547. Epub 2019 Oct 16.
Clinical trial NCT02290119: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing
Official title: PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: Primary PCL-retaining Total Knee Arthroplasty
Intraoperative Sensors
Ligament Balancing
Clinical Outcomes
Lead sponsor: Orthosensor, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

* Pain medication use
* Swelling
* Muscle strength and girth
* Gait efficiency
* Patient satisfaction
* Activity levels, functional return (i.e., back to work, resume normal activities)
* Patient perception of a balanced knee


Eligibility criteria: Inclusion Criteria:

* Subject must be a candidate for a primary PCL retaining total knee arthroplasty
* Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
* Subject is between the age of 45 - 80 years
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees

Primary outcomes:
measure: Rehabilitation Potential
timeFrame: 6 Months
Secondary outcomes:
measure: Knee Society Pain and Functional Scoring (KSS)
timeFrame: 6 month
measure: Forgotten Joint Score (FJS)
timeFrame: 6 month
measure: 3D Gait Analysis velocity
timeFrame: 6 Month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction
state: Maryland
Study officials:
affiliation: Sinai Hospital of Baltimore
name: Ron Delanois, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00234819: Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
Official title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms Associated With Menopause
Keywords: Menopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 325
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
* Intact uterus
* Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria:

* History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
* History of active presence of stroke, TIA, heart attack or ischemic heart disease
* History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Primary outcomes:
measure: Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Secondary outcomes:
measure: Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Ft. Myers
country: United States
state: Florida
city: North Port Richey
country: United States
state: Florida
city: Scarborough
country: United States
state: Maine
city: Albuquerque
country: United States
state: New Mexico
city: Winston-Salem
country: United States
state: North Carolina
city: Pottstown
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
Clinical trial NCT05124418: A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System
Official title: A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palatal Masticatory Mucosa Thickness
Keywords: cone beam computed tomography,dynamic navigation,Palatal maticatory mucosa thickness,non-invasive
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Periodontal plastic surgery is widely used to improve the esthetic and functional demands of patients. The palatal masticatory mucosa is the main donor area. A lot of methods to evaluate the thickness of palatal soft tissue were used. However, the methods published before were invasive or non-reproducible. Therefore, the aim of this study was to investigate the accuracy of the novel invasive method to evaluate the thickness of palatal masticatory mucosa thickness.

Twelve periodontally healthy patients who will have CBCT on maxilla for implant surgery will be recruited in this study. Each patient will be measured at 15 points of palatal masticatory mucosa over canine to the second molar area, it will be done by a dynamic navigation system (test group) and periodontal probe piercing (control group). The data will be analyzed to evaluate the accuracy of dynamic navigation in the measurement of palatal masticatory mucosa thickness.


Eligibility criteria: Inclusion criteria:

1. Above 20 years old
2. The patient need dental implant surgery in maxilla
3. The patient have at least complete canine to second molar at one side
4. Periodontaliy healthy patients
5. The patient could sign for the consent form.

Exclusion criteria:

1. patients can not receive dental implant surgery
2. fuzzy palatal alveolar bone line
3. all maxillary posterior teeth with metal crowns
4. all posterior teeth are missing at one side over maxilla
5. all maxillary posterior teeth with hyper-mobility
6. Pregnancy

Primary outcomes:
measure: measure thickness of palatal masticatory mucosa using dynamic navigation system (in mm) and periodontal probe (in mm)
timeFrame: immediately after examination
Secondary outcomes:
measure: Information of palatal masticatory mucosa thickness in Taiwanese people
timeFrame: immediately after examination
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: CHEN-YING WANG, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02066818: Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
Official title: Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cutaneous Abscess
Pain
Keywords: local anesthetic
incision and drainage
pain
cutaneous abscess
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Local anesthesia used for incision and drainage of abscesses is known to be painful.

We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\&D) of skin abscesses.

Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I\&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Skin abscess in need of incision and drainage (judged by treating physician)

Exclusion Criteria:

* Allergy to lidocaine or tetracaine
* Non-intact skin
* Unable/unwilling to provide informed consent

Primary outcomes:
measure: Change in VAS pain score over time
timeFrame: Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Christina L Bourne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03125018: Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility criteria: Inclusion Criteria:

* Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT02226718: Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
Official title: Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Otitis Media
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients suffering from chronic otitis media, visiting a tertiary referral centre

Brief summary: For measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. However, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. The aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. Following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. Applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. Therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.

Detailed description: See Summary that contains all the details

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of chronic otitis media

Exclusion Criteria:

none

Primary outcomes:
measure: Validity
timeFrame: day 1 (day of consultation)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätsspital Zürich
name: Alexander Huber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835518: An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS
Official title: An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Keywords: The Efficacy and Safety of Adalloce
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those diagnosed with RA or AS

Brief summary: This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study


Eligibility criteria: Inclusion Criteria:

1. Men and women between the ages of over 19 and under 75 at the time of consent
2. Patients diagnosed with RA or AS at least 3 months prior to the study registration
3. Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
4. Patients who have never received Adalloce
5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study

Exclusion Criteria:

1. Patients with hypersensitivity to this drug or its components
2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
3. Patients with moderate to severe heart failure (NYHA class III/IV)
4. Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
5. Patients who are not suitable for participation in this study according to the judgment of the investigator
6. Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)

Primary outcomes:
measure: Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS
timeFrame: 52weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jeongyoon Choi, PI
role: PRINCIPAL_INVESTIGATOR
References: