louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06119958: Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects
Official title: A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* over 19 year old

Exclusion Criteria:

* Galactose intolerance
* Lapp lactase deficiency

Primary outcomes:
measure: Cmax,ss of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: AUCt,ss of DWC202313 and DWC202314
timeFrame: Up to 14 days
Secondary outcomes:
measure: Tmax,ss of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: Cmin,ss of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: t1/2 of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: CLss/F of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: Vdss/F of DWC202313 and DWC202314
timeFrame: Up to 14 days
measure: PTF of DWC202313 and DWC202314
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus YANGJI Hospital
Study officials:
References:
Clinical trial NCT00215358: Study in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Formoterol
Fumarate
Foradil
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.


Eligibility criteria: Inclusion Criteria:

-Require regular use of an inhaled Beta-2-selective adrenergic agent

Exclusion Criteria:

* Active acute or chronic disorders of the respiratory system within one month prior to screening
* Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history
* Recent surgical interventions such as lung lobectomy or resection (\< one year), or cardiothoracic interventions
* Life-threatening systemic and debilitating diseases.

Primary outcomes:
measure: Measure of lung function.
Secondary outcomes:
measure: Change in lung function, vital signs, physical examinations, clinical laboratory assessments, and adverse event reporting.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Medford
country: United States
facility: Research Site
state: Oregon
Study officials:
References:
Clinical trial NCT00549458: Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Week pelvic floor muscle in females
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this randomized controlled trial is to determine whether a standardized Pilates exercise program can effectively strengthen pelvic floor muscles when compared with conventional pelvic muscle rehabilitation.

Urinary incontinence is a widespread problem that affects 10-40% of all ambulatory women and pelvic floor muscle training is an effective treatment for this problem. However, its efficacy is proportionate to the effort expended. Even among women who are diligent with pelvic muscle rehabilitation, long term follow-up reveals that benefits are lost in the absence of maintenance exercises.

While this intervention is effective, recent studies demonstrate that long term adherence to treatment is low. As compliance appears to be a prerequisite to achieving sustained benefit, finding a method of pelvic muscle strengthening that better lends itself to long term commitment could prove beneficial.

The currently popular exercise program, known as Pilates (named after founder, Joseph Pilates) consists of a series of low impact, flexibility and muscle toning exercises. The philosophy centers around developing core strength which includes strengthening the pelvic floor. Its use has been described in the US since the 1920s.4 Five million Americans currently participate, as opposed to five thousand ten years ago.5 Given its mainstream popularity, Pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. Currently, there are no studies that assess the efficacy of Pilates in increasing pelvic muscle strength.


Eligibility criteria: Inclusion Criteria:

* Women 18 yrs or older

Exclusion Criteria:

* Pregnancy
* No pelvic organ prolapse beyond the hymenal ring.
* Age or medical condition that make it difficult for patient to tolerate exam or follow verbal instructions.
* Pacemakers
* IUDs
* Vaginal infections or urinary tract infections
* Medical or physical conditions which exclude the proper performance of Pilates.

Primary outcomes:
measure: Increase pelvic floor strength
timeFrame: Over a 12 week period of time
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Office of Urogynecolgy 95 Madison Avenue Suite 204
state: New Jersey
Study officials:
affiliation: Atlantic Health Urogynecology
name: Patrick Culligan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00574158: Pathogenesis and Genetics of Environmental Asthma Ozone Study
Official title: Project 2: Genetic Regulation of Ozone Induced Inflammation in Humans.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Inflammation
Keywords: ozone
inflammatory airway disease
polymorphisms
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2007-12-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults, 18-35 y of age, both genders.

Brief summary: The goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and 3 specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20 FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have been carried forward to take place in 4 phases:

i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we will increase the numbers of individuals available for study.

ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC, FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3 candidate O3 response genes taken from literature searches and/or previously characterized to demonstrate associations. These physiologic endpoints have been examined in terms of both a continuum of response, and discrete "responder" and "non-responder" endpoints.


Eligibility criteria: Inclusion Criteria:

* Subjects with normal lung function values, and of normal body habitus (i.e., \< BMI of 30);
* Do not have a history of lung disease, and not taking any medications for lung disease or other clinical disorders, and no prior or current smoking history.

Exclusion Criteria:

* Non-willingness to sign a consent form for participation.

Primary outcomes:
measure: Pathogenesis and genetics of environmental asthma ozone study
timeFrame: acute and at 18 to 24 hour followup.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: W Michael Foster, PhD
state: North Carolina
Study officials:
affiliation: Duke University
name: W Michael Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hussain S, Johnson CG, Sciurba J, Meng X, Stober VP, Liu C, Cyphert-Daly JM, Bulek K, Qian W, Solis A, Sakamachi Y, Trempus CS, Aloor JJ, Gowdy KM, Foster WM, Hollingsworth JW, Tighe RM, Li X, Fessler MB, Garantziotis S. TLR5 participates in the TLR4 receptor complex and promotes MyD88-dependent signaling in environmental lung injury. Elife. 2020 Jan 28;9:e50458. doi: 10.7554/eLife.50458.
Clinical trial NCT04423458: Evaluation of Advanced US Tools in Assessing Allograft Complications
Official title: The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Chronic Kidney Diseases
Failure,Kidney
Renal Artery Stenosis
Fibrosis
Complications
Keywords: 3D Ultrasound
US elastography
US MFI
Ultrasound
MRI
CT
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients having /had kindey transplant

Brief summary: This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

Detailed description: This study will focus on monitoring renal after transplantation using all US advanced technology.

Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.

Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.

Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.

Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.

Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Eligibility criteria: INCLUSION CRITERIA

* Patients ≥ 18 years.
* Tx patients.
* Gender.

EXCLUSION CRITERIA

* Prisoners.
* Patients \< 18 years.
* Pregnant women

Primary outcomes:
measure: Peak systolic velocity (cm/s).
timeFrame: 12 weeks
measure: Peak systolic velocity ratio (PSVR).
timeFrame: 12 weeks
measure: Resistive Index (RI).
timeFrame: 12 weeks
Secondary outcomes:
measure: Volumetric stenosis.
timeFrame: 12 weeks
measure: 3D GSM.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Academic Supervisor
name: Mohammed Aslam, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00724958: Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
Official title: Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-07-30
Enrollment: 348
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.

Brief summary: The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.

Detailed description: This study population was chosen from a non-probability sample

Eligibility criteria: Inclusion Criteria:

* Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

* Per summary of product characteristics.

Primary outcomes:
measure: Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
timeFrame: up to 2 years
measure: Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
timeFrame: up to 2 years
measure: Average Dose of Infliximab Per Participant Within the Observation Period
timeFrame: up to 2 years
measure: Median Dose of Infliximab Per Participant Within the Observation Period
timeFrame: up to 2 years
measure: Total Dose of Infliximab Per Participant Within the Observation Period
timeFrame: up to 2 years
Secondary outcomes:
measure: Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02886858: tDCS in the Prevention of Relapse After Electroconvulsive Therapy
Official title: tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
Moods disorders
electroconvulsive therapy
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.

Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.

Detailed description: In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.

Eligibility criteria: Inclusion Criteria:

* 18-75 ans
* Remission (MADRS \<10) of a major depressive episode after acute treatment with ECT + venlafaxine
* Lithium adjunction 48h after the last ECT session
* No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance.
* Capacity to consent
* Sufficient comprehension of the French language

Exclusion Criteria:

* Contra-indications to tDCS
* Neurologic conditions
* Severe medical conditions.
* Pregnancy/breast-feeding.
* Current use of benzodiazepines or antipsychotics

Primary outcomes:
measure: Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
timeFrame: 6 months
Secondary outcomes:
measure: Montreal Cognitive Assesment (MoCA)
timeFrame: basal and at 6 months
measure: Scores on Clinical Global Impression (CGI)
timeFrame: after remission basal and at 6 months
measure: Time to relapse
timeFrame: during 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Rhône Alpes
Study officials:
affiliation: CH LE VINATIER
name: GALVAO FILIPE, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760058: Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Official title: Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cataract
Keywords: cataract, intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 50 and over.
* Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
* Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
* Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
* Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

Exclusion Criteria:

* Subjects who have previously had corneal surgery.
* Subjects who have potential visual acuity which is \< 6/12 due to other ocular pathology
* Subjects with corneal pathology.
* Subjects with astigmatism of greater than 1D.
* Subjects diagnosed with glaucoma.
* Subjects diagnosed with diabetes.
* Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
* Subjects with a know history of poor compliance
* Subjects with planned adjunctive surgery

Primary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.
timeFrame: 3 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT02877758: Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging
Official title: Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Aging
Keywords: cutaneous aging
skin rejuvenation
wrinkles
Lead sponsor: Tomorrowlabs GmbH
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce the visible signs of cutaneous aging.

Detailed description: It is proposed to study a cosmeceutical formulation designed to reduce the visible signs of cutaneous aging. It is expected that daily application of the formulation may minimize wrinkles and fine lines of the face.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face

Exclusion Criteria:

* Subjects who have undergone facial plastic surgery or aesthetic dermatology treatments to the face (such as fillers and neuromodulators) in the past 6 months
* Subjects with a history of collagen vascular disease, cutis laxa, connective tissue disease, psoriasis, or lupus.
* Subjects diagnosed with scleroderma.
* Subjects with a body mass index (BMI) \> 30.
* Subjects taking steroid therapy.

Primary outcomes:
measure: Validated Assessment Scales for Age-related Changes of the Face
timeFrame: 3 months
Secondary outcomes:
measure: Skin quality assessment
timeFrame: 3 months
measure: Subject Satisfaction With the Results
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: JKU
name: Raphael Wenny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.
citation: Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the mid face. Dermatol Surg. 2012 Feb;38(2 Spec No.):320-32. doi: 10.1111/j.1524-4725.2011.02251.x.
citation: Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.