louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831282: Feasibility and Performance Evaluation of INVSENSOR00024
Official title: Feasibility and Performance Evaluation of INVSENSOR00024
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of SpO2 Performance
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 12
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 1 month (28 days) of age
* Weight ≤ 5 kg at the time of consent or last recorded weight prior to consent.
* Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria:

* Subjects with both significant abnormal aortic arch and radial line in place
* Subjects with suspected or diagnosed critical congenital heart disease (CCHD)
* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Deformities of limbs, absence of feet, severe edema, and other at the discretion of the Principal Investigator

Primary outcomes:
measure: Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
timeFrame: up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
References:
Clinical trial NCT04405882: Cornea Ectasia Excimer Laser Treatment
Official title: Combined Technique of Corneal Remodeling to Treat Ectasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Ectasia
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age 31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.

Brief summary: To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Detailed description: Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.

Eligibility criteria: Inclusion Criteria:

- keratoconus with moderate severity (Amsler-Krumeich stage I-II)

Exclusion Criteria:

* concomitant ocular disease
* concomitant systemic disease
* corneal opacities

Primary outcomes:
measure: quality of vision
timeFrame: preoperatively
measure: quality of vision
timeFrame: preoperatively
measure: quality of vision
timeFrame: preoperatively
measure: quality of vision
timeFrame: 6 months postoperatively
measure: quality of vision
timeFrame: 6 months postoperatively
measure: quality of vision
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Luca buzzonetti
state: RM
Study officials:
References:
Clinical trial NCT02206282: Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
Official title: Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Implant Rupture
Lead sponsor: Silimed Industria de Implantes Ltda
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 390
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly selected to undergo MRI detection of asymptomatic rupture using a stratified sampling design, stratifying on implant age (time since implantation). Sixty-five (65) women will be selected from each of six implant age groups between 6-18 years.

Brief summary: A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.


Eligibility criteria: Inclusion Criteria:

* Female
* Subject implanted with the original Silimed gel-filled implant.

Exclusion Criteria:

* MR imaging is not possible because of the following:
* Metal implant
* Battery activated stimulator
* Pregnancy
* Tattoos
* Body weight \>300 pounds
* History of metal fragments in the eye
* Any other contraindication to MR exam.

Primary outcomes:
measure: Magnetic Resonance Image
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Insituto Ivo Pitanguy
name: Wanda Elizabeth Massiere Correa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05984082: Checklist for AI in Medical Imaging (CLAIM) Consensus Panel
Official title: Checklist for AI in Medical Imaging (CLAIM) Consensus Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Intelligence
Machine Learning
Diagnostic Imaging
Keywords: Checklist for AI in Medical Imaging (CLAIM)
Reporting guideline
Delphi consensus method
Survey
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians, AI researchers and journal editors

Brief summary: The investigators will revise the Checklist for AI in Medical Imaging (CLAIM) guideline using Delphi consensus methods. An international panel of physicians, researchers, and journal editors with expertise in AI in medical imaging -- including radiology, pathology, dermatology, GI endoscopy, and ophthalmology -- will complete up to 3 web-based surveys. Participants who complete all survey rounds will be credited as contributors on resulting publications.

Detailed description: The survey will be administered in collaboration with:

* Anthony A. Gatti, PhD (Stanford University)
* Michail E. Klontzas, MD, PhD (University of Crete School of Medicine) \*
* Linda Moy, MD (New York University Grossman School of Medicine)
* John Mongan, MD, PhD (University of California San Francisco)
* Seong Ho Park, MD, PhD (University of Ulsan College of Medicine)
* Ali S. Tejani, MD (University of Texas Southwestern Medical School)

(\*) Survey administrator

Eligibility criteria: Inclusion Criteria:

* More than 70 invited panelists -- physicians, AI researchers, and journal editors -- have agreed to participate in the surveys. Those who participate in all rounds of the survey will be named as contributors in any resulting publications

Exclusion Criteria:

* Non physicians, AI researchers and journal editors

Primary outcomes:
measure: Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Charles E. Kahn, Jr., MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tejani AS, Klontzas ME, Gatti AA, Mongan JT, Moy L, Park SH, Kahn CE Jr; CLAIM 2024 Update Panel. Checklist for Artificial Intelligence in Medical Imaging (CLAIM): 2024 Update. Radiol Artif Intell. 2024 Jul;6(4):e240300. doi: 10.1148/ryai.240300.
Clinical trial NCT01579682: Adaptive Family Treatment for Adolescent Anorexia Nervosa
Official title: Adaptive Family Treatment for Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Eating Disorder
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Maudsley
Family-Based Therapy
FBT
Family Therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2012-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.


Eligibility criteria: Inclusion Criteria:

* Meets DSM-IV criteria for anorexia nervosa
* Lives with at least one English-speaking parent who is willing to participate
* Medically Stable
* Adequate transportation to clinic
* Proficient at speaking, reading, and writing English

Exclusion Criteria:

* Previous FBT for AN
* Medical condition that may affect eating or weight

Primary outcomes:
measure: Full remission from AN (%MBW>95)
timeFrame: End of Treatment (6 months)
Secondary outcomes:
measure: Changes in subscale scores of the EDE
timeFrame: End of Treatment (6 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Stanford University
name: James D Lock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Daniel LeGrange, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776082: Association of Gestational Cardiovascular Health With Pregnancy Outcomes
Official title: Association of Cardiovascular Health During Pregnancy With Perinatal Outcomes---a Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnant Women
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This project intends to recruit pregnant women who go to the research center for routine prenatal examination and give birth.

Brief summary: Pregnancy is a critical period for cardiovascular health risk assessment and interventions to reduce the incidence of cardiovascular disease in both mother and child generations. Recently, the American Heart Association proposed the latest cardiovascular health assessment indicator "Life's Essential 8". However, there is still a lack of application data for pregnant women. This project intends to explore the application potential of Life's Essential 8 in cardiovascular health assessment of pregnant women and establish appropriate gestaional cardiovascular health standards.


Eligibility criteria: Inclusion Criteria:

* Maternal age: 20-49 years;
* Natural conception;
* Single pregnancy;
* Plan to have routine prenatal examinations and give birth in the research center;

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy;
* Assisted reproduction;
* Multiple pregnancy;
* Fetus has a known deformity or genetic defects;
* Incomplete clinical data.

Primary outcomes:
measure: Maternal outcomes
timeFrame: Through delivery completion, up to 42 weeks
measure: Neonatal outcomes
timeFrame: Through delivery completion, up to 42 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01218282: Exercise Training in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Different Methods of Home Exercise Training in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
home exercise training
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity.

This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.


Eligibility criteria: Inclusion Criteria:

* COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

Exclusion Criteria:

* COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.

Primary outcomes:
measure: Exercise Capacity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Pulmonary respiratory unit- University Hospital
Study officials:
affiliation: Università degli Studi di Ferrara
name: Annalisa Cogo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025682: Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO
Official title: Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Infections
Bacterial Infections
Viral Infection
Fungal Infection
Acute Lymphoblastic Leukemia, Adult
Acute Lymphoblastic Leukemia, in Relapse
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with relapsed/refractory CD22 positive acute lymphoblastic leukemia treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor

Brief summary: The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is:

• incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

Detailed description: The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old)
* Patients with relapsed/refractory CD22 positive B-ALL treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
* Signed informed consent if applicable.

Exclusion Criteria:

• Patients treated with INO in interventional clinical trials.

Primary outcomes:
measure: Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: UOC Ematologia Fondazione Policlinico Universitario A.Gemelli
Study officials:
affiliation: Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
name: Livio Pagano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184282: Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer
Official title: Assessment of Topical Mebo Versus Lidocane in Healing Time of Traumatic Oral Ulcer: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mebo
Lidocaine
Healing
Traumatic Oral Ulceration
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess topical MEBO application on pain relief and wound healing.

Detailed description: One of the conditions that affect the mouth frequently is a traumatic ulcer. Between 3 and 24 % of the population are affected, which is a significant prevalence. It is symptomatic to treat traumatized ulcers. Oral wound healing is a dynamic process and complicated phenomenon involving secondary concerns, a succession of overlapping stages of rebuilding cell and tissue structure.

Inflammation, granulation tissue creation, matrix formation, re-epithelialization, and tissue remodeling are some of the cellular and physiological activities that occur during wound healing.

Oral wound healing is a dynamic process and complex phenomenon involving secondary issues, series overlapping stages of restoring tissue and cellular structures.

Since 1995, the Moist Exposed Burn Ointment (MEBO), a Chinese burn ointment, has had a recognized US patent. Beta-sitosterol, Phellodendron amurense, Scutellaria baicalensis, Coptis chinensis, Pheretima aspergillum, Beeswax, and sesame oil are all natural ingredients found in MEBO, a pure herbal extract.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 50 years.
* Both sexes.
* Systemically healthy patients.
* Patients with good oral hygiene.

Exclusion Criteria:

* Patients with any uncontrolled local or systemic disease.
* Smokers.
* Pregnancy and lactation.
* Patients allergic to the used agents.

Primary outcomes:
measure: The degree of pain
timeFrame: 10 days after surgery
Secondary outcomes:
measure: Wound Size
timeFrame: 10 days after surgery
measure: The degree of re-epithelization
timeFrame: 10 days after surgery
measure: The degree of keratinization
timeFrame: 10 days after surgery
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References:
Clinical trial NCT00916682: Structure and Function of Salivary Proteins
Official title: Structure and Function of Salivary Proteins
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Tufts University
name: Boston University
name: Boston Medical Center
name: University of North Carolina, Chapel Hill
name: Ahura Scientific, Inc.
First posted: 2009-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be approached during their pulmonary clinic appointment or while they are inpatient at Children's Hospital, Boston.

Brief summary: This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of current disease status using saliva as a sample specimen.

Detailed description: The overall hypothesis of this study is that whole saliva and its components, due to its direct anatomic relation to the airways, provides a window on the composition and nature of the disease-specific response in the bronchial, sinus, and nasal airways. By examining proteins created in saliva, we hope to validate that saliva is an important diagnostic tool for for rapid analysis of respiratory status. We further propose that rapid salivary diagnostics will improve patient care in prevalent respiratory diseases with frequent health care utilization and high morbidity, such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF).

Eligibility criteria: Inclusion Criteria:

* 6 or more years of age
* confirmed Cystic Fibrosis

Exclusion Criteria:

* Pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hosptital, Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Ahmet Uluer, DO
role: PRINCIPAL_INVESTIGATOR
References: