louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01838785: Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects
Official title: Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: 18F-DTBZ AV-133 imaging
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Detailed description: The primary objective of this protocol is to assess the possible age-dependent decline in striatal 18F-DTBZ uptake of healthy subjects.

This study is expected to be completed in a period of 2 years.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 20 years to 80 years.
2. Subjects without significant neuropsychiatric disorder after evaluation by Neurologist.
3. Subjects who provide a written informed consent prior to study entry. If the subject is incapable of informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).

Exclusion Criteria:

1. Pregnancy and breast feeding.
2. Significant recent (within 6 months) history of neurological (including stroke and brain trauma) or psychiatric disorder.
3. Alcohol or substance abuse within last year.
4. Parkinson's disease or other brain degenerative disease (spinocerebellar ataxia, Wilson's disease, hydrocephalus, multiple infarction, history of severe head injury or intracranial operation.
5. Unable to stay still in the MRI or PET scanner for 30 minutes.

Primary outcomes:
measure: Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.
timeFrame: two years
Secondary outcomes:
measure: The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06383585: 3D DL Ozteo in the Detection of Osseous Changes in Patients with Inflammatory Arthritis
Official title: Evaluation of 3D DL OZTEo in the Detection of Osseous Changes in Patients with Inflammatory Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2024-04-25
Enrollment: 25
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: This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI.

Detailed description: This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years of age
* Hand radiographs performed within the past 3-6 months with imaging results available for analysis
* Hand radiographs confirm the presence of bony erosions
* Scheduled for a hand MRI as part of their routine clinical care at Mayo Clinic Rochester

Exclusion Criteria:

- Less than18 years of age

Primary outcomes:
measure: The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.
timeFrame: 1 day
Secondary outcomes:
measure: The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.
timeFrame: 1 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Naveen Murthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05108285: Dark Halo and MNV: a Study Between ICGA and OCTA
Official title: Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Neovascularisation
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to evaluate which of two methods is able to detect in a peculiar way the dark halo around the MNV

Brief summary: The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV

Detailed description: Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced choroidal flow adjacent to the macular neovascularization (MNV).

The detection of MNV vascular details was only possible through invasive dye injection, such as fluorescein angiography (FA) or indocyanine green angiography (ICGA).

Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to detect the perfusion and non-perfusion areas carefully.

The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA

Eligibility criteria: Inclusion Criteria:

* age older than 55 years
* diagnosis of macular neovascularization
* absence of previous treatment with anti-Vegf injections
* absence of other retinal vascular diseases

Exclusion Criteria:

* age younger than 55 years
* absence diagnosis of macular neovascularization
* presence of previous treatment with anti-Vegf injections
* presence of other retinal vascular diseases

Primary outcomes:
measure: Dark halo measurement
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Università Federico II
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fossataro F, Cennamo G, Montorio D, Clemente L, Costagliola C. Dark halo, a new biomarker in macular neovascularization: comparison between OCT angiography and ICGA-a pilot prospective study. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3205-3211. doi: 10.1007/s00417-022-05693-8. Epub 2022 May 6.
Clinical trial NCT00345085: Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
Official title: Comparison of Higher Order Aberrations and Contrast Sensitivity Between Acrysof SN60AT, SN60WF and Restore Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This project involves evaluation of post operative contrast sensitivity and wavefront aberration results among patients implanted with standard monofocal lenses (Acrysof SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher Order aberrations are visual phenomena such as glare and haloes. They are more prevalent after cataract surgery and can affect night driving.

Detailed description: The Project involves evaluation of contrast sensitivity and higher order aberrations in patients implanted with SN60AT, SN60WF and ReSTOR intraocular lenses. Patients in the department of Ophthalmology will be asked to participate in the study on a routine postoperative visit at least 3 months after cataract surgery. Patients will be asked to sign a consent form prior to participation. Wavefront analysis involves the patient resting their chin in a device similar to a slit lamp; they focus on a distant light and the machine performs the measurements in mesopic and scotopic conditions (light and dark). Contrast sensitivity is a measure of how faded or washed out an image can be before it becomes indistinguishable from a uniform field; it involves the patient identifying patterns on a chart. Wavefront analysis and contrast sensitivity are noninvasive tests that do not employ sedation or anesthesia and does not expose the patient to x-rays or microwaves. The proposed research will not alter usual standard postoperative care and can be done on a routine office visit.

Eligibility criteria: Inclusion Criteria: All subject implanted with either SN60AT, SN60WF or ReSTOR intraocular lenses after cataract removal. Subjects include those 18 yrs and over, male and female, all races. Patients will sign an informed consent

Exclusion Criteria: Patients younger than 18 yrs. Patients with other concurrent visually significant ophthalmic disease.

Primary outcomes:
measure: post operative wavefront aberration
Secondary outcomes:
measure: post operative contrast sensitivity
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSW Medical Center at Dallas
state: Texas
Study officials:
affiliation: UTSW Medical Center at Dallas
name: James P McCulley, M.D.
role: STUDY_CHAIR
affiliation: UTSW Medical Center at Dallas
name: Shady Awwad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02636985: Application of Ultrasonic Elastography in Lung Lesions
Official title: Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elastography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with radiographic findings of consolidation, obstructive pneumonitis or tumors, detected on chest computed tomography (CT), who received ultrasound study with or without ultrasound-guided biopsy for tissue proof and UE, from December 2011 to March 2013.

Brief summary: Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a mainstream tool for ultrasound-based diagnosis. This compressibility property of materials, mathematically expressed as the change in tissue displacement as a function of its distance from the compressing device, is known as strain and is the parameter that is imaged in an elastogram.

Elastography has currently shown promising result in differentiating viscoelastic nature of various organs, which is a consequence of certain underlying diseases.

At present, there are limited literatures revealing the application and feasibility of ultrasonic elastography in lung lesions. This is essentially important as it may serve as an adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and feasibility of ultrasonic elastography on lung lesions.

Detailed description: Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound elastography. The strain ration was measured and was compared between necrosis, atelectasis, consolidation and tumor.

Eligibility criteria: A. Inclusion Criteria:

Patients with radiographic findings of:

1. consolidation
2. obstructive pneumonitis
3. tumors

B. Exclusion Criteria:

1. Patients with poor acoustic window
2. Unable to hold breathing
3. Not cooperative
4. Presence of pleural effusion

Primary outcomes:
measure: Comparison of strain ratio between necrosis, atelectasis, consolidation and tumor
timeFrame: Up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei City
Study officials:
affiliation: National Taiwan University Hospital
name: Hao-Chien Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim CK, Chung CL, Lin YT, Chang CH, Lai YC, Wang HC, Yu CJ. Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases. Ultrasound Med Biol. 2017 Jan;43(1):145-152. doi: 10.1016/j.ultrasmedbio.2016.08.028. Epub 2016 Oct 12.
Clinical trial NCT02638285: Pregnancy Rate by HCG Administration Versus Urinary LH Surge Method in Patients Undergoing IUI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine Insemination (IUI) at Montaserieh infertility center.

The present study comprised 309 infertile women candidate for IUI, randomly divided into LH surge and HCG groups (assign the number for each patient, odds number for LH and even number for HCG group). All patients were subjected to baseline ultrasound and received clomiphene citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when 2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after 24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36 hours. The pregnancy rate was then compared in LH and HCG groups.


Eligibility criteria: Inclusion Criteria:

* infertile women candidate for IUI

Exclusion Criteria:

* women with negative urinary LH surge which required HCG administration,
* those with more than 5 follicles who had to use LH kit and not receive HCG to avoid ovarian hyperstimulation.

Primary outcomes:
measure: pregnancy rate
timeFrame: Two weeks after IUI
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Health Policy Research Center
state: Fars
Study officials:
References:
Clinical trial NCT03247985: Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair
Official title: Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Mesh
Repair
Peritoneal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.

Detailed description: Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.

Eligibility criteria: Inclusion Criteria:

- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.

Exclusion Criteria:

- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.

Primary outcomes:
measure: Mean Operative Time
timeFrame: First incision to closure, approximately one hour
measure: Number of Participants With Early Postoperative Complications
timeFrame: Within 30 days
Secondary outcomes:
measure: Pain Score at Baseline
timeFrame: baseline
measure: Pain Score at One Week
timeFrame: One Week Postoperative
measure: Pain Score at Four Weeks
timeFrame: Four Weeks Postoperative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Farley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366985: Dimensional Changes of the Labial Alveolar Ridge After Socket Shield Technique With Computer Guided Root Sectioning
Official title: Digital Evaluation of the Early Volumetric Changes of the Labial Alveolar Contour Following Guided Socket Shield Technique for Immediate Implant Placement: A Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge
Dental Trauma
Keywords: Bone implant interactions
Periodontology,
Soft tissue-implant interactions
Surgical techniques
Wound healing
Lead sponsor: Pharos University in Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2022-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the dimensional changes of the labial alveolar ridge are digitally assessed after immediate implant placement using the socket shield technique with computer guided sectioning of the root.

Detailed description: Ten hopeless teeth in the esthetic zone were included. A computer guide was used to section the root, leaving the coronal 2/3 of its labial part attached to the socket. An implant was then placed.

Preoperative and Postoperative (5 months later) intraoral scans were superimposed with a digital software to assess the dimensional changes of the labial alveolar ridge. Linear changes at 1,3 and 5 mm from the gingival margin and mean linear changes in a specified Area Of Interest (AOI) were measured.

Eligibility criteria: Inclusion Criteria:

* medically healthy patients (ASA 1, ASA 2 categories) ,
* over 18 years old presenting with hopeless teeth due to extensive caries,
* cervical root fracture,
* vertical or oblique root fracture,
* multiple failed endodontic treatments,
* root resorption.

Exclusion Criteria:

* medically compromised patients (the ASA 3, ASA 4 and ASA5 categories)
* vertical root fracture involving the labial aspect of the root that will be retained,
* horizontal fracture of the root that is too far apically located
* presence of acute (active) periapical infection
* lack of sufficient bone to obtain implant primary stability apical and/or palatal to the extraction socket,
* ankylosed tooth which is positioned too apically in relation to the adjacent teeth,
* type 3 extraction sockets according to Elian and Tarnow extraction sockets classification

Primary outcomes:
measure: dimensional changes of the labial alveolar ridge in orofacial direction in millimeters using GOM Inspect software
timeFrame: 5 months
measure: Thickness of the labial plate of bone in millimeters on the preoperative CBCT radiograph
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university, Faculty of dentistry
Study officials:
affiliation: Alexandria university, Faculty of dentistry
name: Ahmed K Nabawy, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066685: Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program
Official title: Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Keywords: Primary plan,
AMD characteristics,
brolucizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 18457
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included patients with wet AMD

Brief summary: The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics.

Detailed description: The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program.

PSS data was obtained from patients with wet AMD who enrolled in the program for the index period 10/10/2019 to 04/30/2020.

* Identification period of the index period: 10/10/2019 to 04/30/2020
* Index date: Date of enrollment in the PSS program
* Study Period: 10/10/2019 to 04/30/2020

Eligibility criteria: Inclusion Criteria:

* Patients were enrolled in the brolucizumab PSS program
* ≥19 years old

Exclusion Criteria:

• None

Primary outcomes:
measure: Number of patients with Primary plan type
timeFrame: Index date defined as the date of enrollment in the PSS program
Secondary outcomes:
measure: Age
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Gender
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Patient region (by state)
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Provider region (by state)
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Insurance coverage
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Number of patients with Secondary plan type
timeFrame: Index date defined as the date of enrollment in the PSS program
measure: Disease Status
timeFrame: Index date defined as the date of enrollment in the PSS program
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: