louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129072: Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
Official title: Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wearer
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
3. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.

Primary outcomes:
measure: Spherical aberration measurement
timeFrame: 60 minutes
Secondary outcomes:
measure: Visibility of Toric Etch Mark by the Investigator
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch and Lomb Site 01
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813472: Hydration Sensor for Atopic Dermatitis
Official title: Validation of Skin Hydration Sensor for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Healthy Children
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 172
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, aged matched controls or children with prior diagnosis of atopic dermatitis as confirmed by clinical diagnosis by a board-certified dermatologist

Brief summary: Pilot study of a soft, flexible hydration sensor

Detailed description: Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.

Eligibility criteria: Inclusion Criteria:

* Children \<18 years of age
* Children with new or prior atopic dermatitis diagnosis
* English speaking
* Children who are healthy, aged matched controls

Exclusion Criteria:

* Individuals who are pregnant

Primary outcomes:
measure: Percent Agreement
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688072: Trunk Oriented Exercises Versus Whole-body Vibration for Duchenne Muscular Dystrophy
Official title: Trunk Oriented Exercises Versus Whole-body Vibration on Abdominal Thickness and Balance in Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Duchenne Type
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The abdominal muscles play an important role in stabilizing the trunk and providing postural stability. Children with Duchene muscular dystrophy have weak muscles, which may impair postural adjustments. These postural adjustments are required for gait and dynamic balance during the daily living activities.


Eligibility criteria: Inclusion criteria:

* diagnosed as Duchenne muscular dystrophy,
* aged from 6 to 10 years,
* having grade 3+ muscle strength in lower limbs and trunk muscles.
* had functional range of motion for upper and lower limb joints,
* able to walk alone level I and II of Ambulation function classification system for DMD (AFCSD)
* Exclusion criteria:
* congenital or acquired skeletal deformities or cardiopulmonary dysfunction,
* had undergone previous orthopedic surgery in lower limbs,
* had abnormal motor development or neurological disease that affect balance
* and gait, and
* behavioral problems causing inability to cooperate during the study.

Primary outcomes:
measure: abdominal muscle thickness
timeFrame: change from base line at 4 weeks.
Secondary outcomes:
measure: balance assessment
timeFrame: change from base line at 4 weeks.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: marwa S saleh
Study officials:
References:
Clinical trial NCT06507072: Adaptive Rock Climbing
Official title: Evaluating Adaptive Rock Climbing on Children With Upper Limb Differences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Upper Limb Differences
Keywords: Adaptive sports
Rock climbing
Congenital Upper Limb Differences
Improved psychosocial health
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to assess changes in functional and psychosocial outcomes following a 12-week adaptive rock-climbing program for children with congenital upper limb differences. The main questions it aims to answer are

* Assess functional outcomes following a 12-week adaptive rock-climbing program.
* Assess psychosocial outcomes following a 12-week adaptive rock climbing program.
* Assess barriers to participation in adaptive sports.

Participants will complete 12-week adaptive rock climbing program.


Eligibility criteria: Inclusion Criteria:

* Parents 18 years and older.
* English or Spanish speaking.
* Participants with unilateral or bilateral congenital upper extremity disorders of limb formation differences ages 6-16.

Exclusion Criteria:

* Any patients younger than 6 years or older than 16 years, patients not fluent in English or Spanish, or patients with parents younger than 18 years.

Primary outcomes:
measure: Change from Baseline in Range of Motion at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in KINDL Scores at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in Muscle Testing at 12 Weeks.
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in PROMIS Life Satisfaction Scores at 12 Weeks.
timeFrame: Baseline and 12 weeks
measure: Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Assess Barriers to Participation in Adaptive Sports
timeFrame: At 12 weeks (post-intervention)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Nina Lightdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02480972: Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging
Official title: Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosis
Cirrhosis
Keywords: fibrosis
cirrhosis
MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2015-06-25
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.

Detailed description: In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.

Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.

The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.

Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo liver resection for focal liver lesion
* patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
* liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
* AND patients/living donor candidates who sign informed consent

Exclusion Criteria: Patients who have at least one of followings are excluded.

* Patients who are contraindication for MRI contrast enhanced MRI.
* Premenopausal female patients who are pregnant.
* Patients who are physically compromised to acquire liver MRI

Primary outcomes:
measure: difference of portal flow between no or early hepatic fibrosis and advanced hepatic fibrosis
timeFrame: in three years
Secondary outcomes:
measure: difference of arterial flow between no or early hepatic fibrosis and advanced hepatic fibrosis
timeFrame: in three years
measure: difference of liver stiffness value between no or early hepatic fibrosis and advanced fibrosis
timeFrame: in three years
measure: monitoring of transient dyspnea after contrast media injection
timeFrame: in three years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00958672: Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy
Official title: Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations

Brief summary: The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Systemic sclerosis based on the ACR diagnostic criteria

Exclusion Criteria:

* Patients with other connective tissue diseases
* Pregnancy
* Absence of contraception in women
* Patients with pace maker
* Patients with intestinal pseudo-obstruction

Primary outcomes:
measure: Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
timeFrame: 1 year
Secondary outcomes:
measure: - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms
timeFrame: 1 year
measure: to assess a correlation between small intestinal mucosal abnormalities and nutritional status
timeFrame: 1 year
measure: to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU-Rouen
Study officials:
References:
Clinical trial NCT04150172: To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers
Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between "Rebamipide Sustained Release (SR) 150mg" and "Rebamipide Immediate Release (IR) 100mg" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

1. Subjects who give consent to voluntary participation by signing the informed consent form
2. Healthy adult males aged ≥19 and ≤45 years at screening
3. Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0

Exclusion Criteria:

1. Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
2. Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
3. Subjects who have participated in other clinical trial and received any other investigational products within 3 months before the expected date of IP administration
4. Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
5. Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
6. Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
7. Smokers who have smoked \>10 cigarettes per day within the last 6 months
8. Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and venereal disease research laboratory (VDRL) tests

Primary outcomes:
measure: Cmax
timeFrame: From Period1/ Day1 to Period2/Day9
measure: AUClast of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
Secondary outcomes:
measure: t1/2 β of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
measure: Tmax of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
measure: AUCinf of Rebamipide
timeFrame: From Period1/ Day1 to Period2/Day9
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02154672: Prostate Cancer Screening in Men With Germline BRCA2 Mutations
Official title: Prostate Cancer Screening in Men With Germline BRCA2 Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 1
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be identified because of their BRCA2 mutation that places them at increased risk for developing prostate cancer. Because this is a pre-selected high-risk population, and our goal is to establish the incidence of cancer and association of risk factors with developing disease, all men ≥30 years of age, able to give informed consent, and with at least a 5-10 year life expectancy will have PSA testing, prostate examination, Pelvic MRI, and Artemis fusion prostate biopsy.

Men identified to have prostate cancer will be treated according to current standards of care. Treatment for prostate cancer at the Yale Cancer Center is largely based on clinical risk; options include, but are not limited to, active surveillance for appropriate men with low risk disease, treatment with curative intent for men with localized intermediate and high risk prostate cancer, and systemic therapy for men with metastatic disease.

Brief summary: The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.

Detailed description: This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.

Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.

Eligibility criteria: Inclusion Criteria:

* All men ≥30 years of age with at least a ten-year life expectancy
* A known BRCA2 mutation
* Ability to have an MRI
* Able to give informed consent will be approached to participate in the study

Exclusion Criteria:

* If a man has received or is currently receiving treatment for prostate cancer

Primary outcomes:
measure: Number of Prostate Cancer Patients With BRCA2 Mutation Carriers
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Preston Sprenkle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120872: Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis
Official title: Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Three Wall Intrabony Defects in Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

Detailed description: 90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Eligibility criteria: Inclusion Criteria:

* Subjects with the diagnosis of chronic periodontitis
* presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph \[IOPA\])
* interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion Criteria:

* Subjects, with the diagnosis of aggressive periodontitis,
* with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
* insufficient platelet count (\< 200,000/mm3),
* pregnancy / lactation
* use of any form of tobacco
* unacceptable oral hygiene (if plaque index \[PI\] (Silness \& Loe 1964) \>1.5) after the reevaluation of phase I therapy
* teeth with furcation defects
* non-vital
* mobility of tooth ≥ Grade II

Primary outcomes:
measure: The primary outcome measure of the study was defect depth reduction evaluated radiographically
timeFrame: At baseline and 9 month after surgery
Secondary outcomes:
measure: Probing Depth
timeFrame: At baseline and 9 month after surgery
measure: Relative Attachment Level
timeFrame: At baseline and 9 month after syrgery
measure: modified Sulcul Bleeding Index
timeFrame: At baseline and 9 month after surgery
measure: Plaque Index
timeFrame: At baseline and 9 month after surgery
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
affiliation: Government Dental College and Research Institute, Bangalore
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References: