louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01913496: Development of Web Application and Evaluation Its Impact on Healthy Lifestyle
Official title: Development of Internet Web Application and Evaluation of Its Impact as a Tool in Promoting Healthy Lifestyle Indicators in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle
Keywords: web application
nutrition knowledge
physical activity
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2013-08-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is planned for people who would like to reduce or maintain their weight and keep a healthy life style .After signing an informed consent, participants will be divided randomly into two groups :control group and an intervention group that will get the application (eBalance ). Participants will be followed for 12 weeks.

Detailed description: Primary objective: to develop a web application based on energy balance and evaluates its effectiveness in promoting healthy lifestyle habits versus a control group.

Secondary objectives:

1. To evaluate the frequency and convenient of usage of the internet intervention
2. To test the impact of the intervention on nutrition knowledge, diet quality and physical activity
3. To evaluate the effect of the intervention on weight management status

Eligibility criteria: Inclusion Criteria:

* People aged more than 18 years
* Web and e-mail experience
* Interested in either reducing weight or maintaining a healthy lifestyle

Exclusion Criteria:

* without any mail experience
* pregnancy
* involvement in other diet programs

Primary outcomes:
measure: weight
timeFrame: 14 weeks
Secondary outcomes:
measure: duration of physical activity
timeFrame: 14 weeks
measure: Nutrition knowledge
timeFrame: 14 weeks
measure: waist circumference
timeFrame: 14 weeks
measure: height
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University
Study officials:
affiliation: Hebrew University
name: Jenny Naimark, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Safran Naimark J, Madar Z, Shahar DR. The impact of a Web-based app (eBalance) in promoting healthy lifestyles: randomized controlled trial. J Med Internet Res. 2015 Mar 2;17(3):e56. doi: 10.2196/jmir.3682.
Clinical trial NCT04928196: Retinal Microvasculature Before and After Silicone Oil by OCTA
Official title: Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vascular
Keywords: retinal microvasculature
microperimtry
OCTA
Silicone oil
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective observational case series of patients before and after silicone oil removal

Brief summary: Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Detailed description: Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Eligibility criteria: Inclusion Criteria:

* 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Exclusion Criteria:

* Proliferative diabetic retinopathy, recurrent detachment or macular hole
* Patients with chorioretinal degenerations involving the macula
* Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
* Media opacity hindering proper imaging

Primary outcomes:
measure: Macular and optic nerve head vascular density
timeFrame: one year
measure: Retinal sensitivity by microperimetry
timeFrame: one year
Secondary outcomes:
measure: Retinal vascular density and best corrected visual acuity
timeFrame: one year
measure: Optic nerve head vascular density and best corrected visual acuity
timeFrame: one year
measure: Retinal sensitivity and best corrected visual acuity
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University teaching hospital
Study officials:
affiliation: Kasr El Aini Hospital
name: Hebatalla S. Makled, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr El Aini Hospital
name: Ghada A. Nassar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr El Aini Hospital
name: Maha M. Youssef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr El Aini Hospital
name: Lameece M. Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258296: Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Official title: Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain After Breast Reconstruction With Abdominal Flap
Keywords: Postoperative pain
Breast reconstruction
Abdominal flap breast reconstruction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 60
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: The aim of this randomized, double-blind controlled trial is to determine the efficacy of transdermal fentanyl for the management of early postoperative pain in women undergoing mastectomy followed by immediate TRAM or DIEP flap reconstruction. We will examine whether the use of the fentanyl patch as a bridge between epidural and oral analgesia will improve overall pain relief compared to placebo patch. We further propose to study whether the fentanyl patch is associated with improved ability to sleep, patient satisfaction, and functional capacity at one week, and whether it is associated with different side effects than standard therapy without the patch. Following informed consent, patients will undergo mastectomy and reconstruction, and receive epidural fentanyl for initial postoperative analgesia. Patients will be randomized to active (25 mcg/hr Duragesic) or placebo patches on postoperative day three, and the epidural will be weaned over the next 12 hours. Pain intensity scores and relief from pain will be assessed every day while in the hospital and oral and IV opioid use recorded. Patients will be discharged to home with a supply of 2 patches and oral medication, and will be asked to fill out a daily pain and medication log.


Eligibility criteria: Inclusion Criteria:

* Undergoing breast reconstruction with abdominal flap
* Provided written, informed consent

Exclusion Criteria:

* Karnofsky performance status ≥80%

Primary outcomes:
measure: Opioid analgesic use
timeFrame: 10-20 days
Secondary outcomes:
measure: Pain intensity
timeFrame: 10-20 days
measure: Relief from pain
timeFrame: 10-20 days
measure: Adverse event questionnaire
timeFrame: 10-20 days
measure: Functional assessment questionnaire
timeFrame: 10-20 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura Esserman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Laura Petrillo, BA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03860896: GB004 in Adult Subjects With Active Ulcerative Colitis
Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Ulcerative Colitis
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.

Detailed description: The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.

Exclusion Criteria:

* Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
* Patients receiving biologic agents and experimental agents are excluded.

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 56 Days
Secondary outcomes:
measure: Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
timeFrame: Day 1 to Day 28
measure: Pharmacokinetics: Maximum Concentration (Cmax) of GB004
timeFrame: Day 1 to Day 28
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine
city: Chisinau
country: Moldova, Republic of
facility: PMSI Republican Clinical Hospital "Timofei Mosneaga"
Study officials:
References:
citation: Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10.
Clinical trial NCT05615896: Data Collection With the P200TE and P200TxE
Official title: Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A
Primary purpose: OTHER

Brief summary: The primary objective is to collect OCT scans on a modified P200TxE and P200TE.


Eligibility criteria: Inclusion Criteria :

* Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
* Volunteers who can follow the instructions by the clinical staff at the clinical site;
* Volunteers who agree to participate;
* Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.

Exclusion Criteria:

* Volunteers unable to tolerate ophthalmic imaging;
* Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.

Primary outcomes:
measure: Collection of images
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Retina Consultants of Texas Research Centers
state: Texas
Study officials:
References:
Clinical trial NCT05986396: Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
Official title: Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Prosthesis
Keywords: Pulmonary Valve Replacement
Pulmonary Valve
Congenital Heart Disease
INSPIRIS Resilia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with congenital heart disease that have received the INSPIRIS Resilia device.

Brief summary: The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.

Detailed description: The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.

Eligibility criteria: Inclusion Criteria:

Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.

Exclusion Criteria:

Subjects that have not received the INSPIRIS Resilia device.

Primary outcomes:
measure: Contribute to the scarce body of literature
timeFrame: 5 years after implantation
Secondary outcomes:
measure: Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
timeFrame: 5 years after implantation
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Baylor College of Medicine at CHRISTUS Children's
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Victor Bautista-Hernandez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724796: Yoga 4 Body Image (Y4BI): Investigating the Impact of Yoga on Body Image and Eating Behaviours
Official title: Yoga 4 Body Image (Y4BI): Investigating the Impact of Yoga on Body Image and Eating Behaviours in Young Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Dissatisfaction
Body Image
Eating Behaviors
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The practice of yoga can positively impact body image, a psychological construct encompassing perceptual, emotional, cognitive, and behavioral aspects, which can be either positive or negative. Negative body image manifests as extreme dissatisfaction with one's body-a condition particularly common among young women-that places them at significant risk for developing Body Image Disorders (BIDs). In contrast, positive body image is characterized by an overall respect for one's body.

Current research on the impact of yoga on body image has several limitations, making it challenging to determine whether yoga practice truly has a positive effect on body image and to identify the mechanisms underlying this impact. To address these gaps, the present project aims to overcome the limitations of existing studies by investigating the impact of yoga on body image through quantitative methodologies and by exploring the mechanisms that drive this effect.

The project consists of two phases:

1. Investigating the impact of yoga on body image (both positive and negative) and eating behaviours in a population characterized by high levels of body dissatisfaction-young women.
2. Examining the psychological mechanisms underlying yoga's impact on body image, including increased interoceptive awareness, embodiment, and self-compassion, as well as a reduction in self-objectification.


Eligibility criteria: Inclusion Criteria:

* Females
* Age 18-35 years old

Exclusion Criteria:

* Regular yoga practice
* Pregnancy
* Medical conditions that preclude yoga practice (e.g., neurodegenerative diseases, recent injuries, rheumatic conditions)
* Full-blown body image disorder

Primary outcomes:
measure: Negative Body Image
timeFrame: 10 weeks
measure: Body Appreciation
timeFrame: 10 weeks
measure: Functionality Appreciation
timeFrame: 10 weeks
measure: Dysfunctional Eating Behaviours and Risk of Developing Eating Disorders
timeFrame: 10 weeks
measure: Functional Eating Behaviors
timeFrame: 10 weeks
Secondary outcomes:
measure: Embodiment
timeFrame: 10 weeks
measure: Interoceptive Awareness
timeFrame: 10 weeks
measure: Self-compassion
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Department of General Psychology, University of Padova
Study officials:
References:
Clinical trial NCT04198896: The Sakakibara Health Integrative Profile of Atherosclerotic-Carcinogenesis Hypothesis (SHIP-AC)
Official title: Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancers
Atheroscleroses, Coronary
Atherosclerosis of Artery
Keywords: Atherosclerosis, cancers
Lead sponsor: Sakakibara Heart Institute
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 8856
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: same as eligibility criteria

Brief summary: As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis in cancer developments. In the present study, to address our hypothesis that cancer developments may come with a strength of atherosclerosis, we traced an incidence of cancers in a total of 8,856 patients with coronary artery diseases (CAD) for a median follow-up of 1,095 days (interquartile range, 719-1,469 days) using the Sakakibara Health Integrative Profile (SHIP) database.

Detailed description: In accordance with a presence or absence of poly-arterial diseases such as aortic and/or peripheral artery diseases as an indicator of a strength of atherosclerosis, an incidence of cancers and all-cause death in two cohorts of 8,140 patients with CAD-only and 716 with CAD with poly-arterial diseases were evaluated to track an incidence of cancers and ali-cause mortality during median follou-up periods of 3 to 4 years.

Eligibility criteria: Inclusion Criteria:

* patients with diagnosed coronary artery diseases without a dignosis of cancers at the entry of SHIP between January 2009 and July 2014.

Exclusion Criteria:

* patients with diagnosed coronary artery diseases who had already been diagnosed with any cancers at the time of enrollment in the SHIP, and who were not followed-up after the entry of SHIP.

Primary outcomes:
measure: inicidence of cancers
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04952896: Clinical Study of Magnetic Resonance Imaging and Deep Learning of Joint Synovial Disease
Official title: Using Magnetic Resonance Imaging and DL Methods to Explore the Diagnosis and Clinical Prognosis of Joint Synovitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Synovial Diseases
Pigmented Villonodular Synovitis
Gout
Rheumatoid Arthritis
Keywords: pigmented villonodular synovitis
deep learning
knee synovitis
MRI
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with joint synovial disease through radiological examination, arthroscopy or pathological biopsy of the joint, or whose clinical manifestations meet the diagnostic criteria of the American College of Rheumatology (ACR) for joint synovial disease.

Brief summary: Through the high-throughput feature extraction of magnetic resonance images, the deep learning prediction model of joint synovial lesions is constructed used for the diagnosis, differential diagnosis and curative effect monitoring of joint synovial lesions.

Detailed description: The study applies magnetic resonance and deep learning (DL) to the diagnosis of joint synovial lesions, aims to have a more comprehensive understanding of the pathophysiology of the occurrence and development of joint synovial lesions. As a non-invasive imaging method to assess the condition of the disease, DL methods excavates the deep features contained in the image, quantifies the joint synovial lesions, and then gives more information to the clinician in the diagnosis and differential diagnosis of the joint synovial lesions, provide important information for the planning of individualized treatment plans for patients with joint synovial diseases.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with joint synovial disease through radiological examination, arthroscopy or pathological biopsy of the joint, or whose clinical manifestations meet the diagnostic criteria of the American College of Rheumatology (ACR) for joint synovial disease.
2. Patients received pre-treatment MR.

Exclusion Criteria:

1. Patients who have received surgery, medication or other systemic treatment before standardized MRI scan.
2. Poor image quality.
3. Articular hemorrhage.

Primary outcomes:
measure: Patient's diagnosis
timeFrame: 2019-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
state: Please Select An Option Below
Study officials:
References: