louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01875783: OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
Official title: Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetic Macular Edema
Diabetic Retinopathy
Keywords: diabetes
diabetic macular edema
diabetic retinopathy
optical coherence tomography
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Juvenile Diabetes Research Foundation
name: Optovue
First posted: 2013-06-12
Enrollment: 385
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 protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus as evidenced by:
* Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
* Documented diabetes by American Diabetes Association and/or World Health Organization criteria
* Age greater than or equal to 18 years old
* Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
* Able and willing to participate in study procedures and comply with study follow-up visits
* Able to give informed consent for study participation
* Not moving out of the study area during the 1 year follow-up period

Exclusion Criteria:

* Unable to cooperate with the OCT image acquisition procedure or other study procedures
* Unable or unwilling to comply with the study follow-up visits
* Unable or unwilling to sign form for release of retinal medical records

Primary outcomes:
measure: Rates of Retina Care Referral for Patients With Diabetic Macular Edema
timeFrame: Baseline visit
Secondary outcomes:
measure: Retinal Referral Rates for Patients With DME
timeFrame: Baseline visit
measure: Rates of Retinal Treatment for Patients With DME
timeFrame: One month
measure: Rates of Retinal Treatment Over 1 Year for Patients With DME
timeFrame: 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Wellfleet
country: United States
facility: OuterCape Health Services, Inc
state: Massachusetts
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chattanooga
country: United States
facility: University of Endocrine Consultants
state: Tennessee
Study officials:
affiliation: Joslin Diabetes Center
name: Jennifer K Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690983: Tau PET/CT in Various Tau-Related Disease Patients
Official title: Tau PET/CT in Various Tau-Related Disease Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tauopathies
Neurodegenerative Diseases
Neurodegeneration
Keywords: PET/CT
MRI
Tau
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Tau PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 18F-S16/T807 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Detailed description: Subjects with various Tau-related disease patients underwent 18F-S16/T807 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-S16/T807 PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Tau PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00722683: Evaluate Breast Masses Using a New Method of Ultrasound Contrast to Detect Abnormal Blood Flow in Breasts
Official title: Characterization of Breast Masses Using a New Method of Ultrasound Contrast Agent Imaging in 3D Mapping of Vascular Anomalies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Breast Abnormalities
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 0
Sex: FEMALE
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 determine if breast imaging with ultrasound can be improved by using 1) a ultrasound attachment with two transducers and 2) a contrast agent. These changes might allow smaller blood vessels to be seen than under the way breast ultrasound is usually performed.

Detailed description: The purpose of this study is to determine if performing ultrasound with an attachment made up of two transducers (rather than just a single transducer) will provide more information about the blood vessels in the breast than the current attachment.

The study will also examine the question of whether use of an ultrasound contrast agent will the scanner to see smaller blood vessels than are detected without the agent.

Eligibility criteria: Inclusion Criteria:

* Female subjects who have breast masses and scheduled for core biopsy.

Exclusion Criteria:

* Pregnant or lactating females.
* Females who have heart problems or sensitivity to contrast agents.
* Females who have had previous surgery for breast cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jerry L. LeCarpentier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492383: SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
Official title: SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Aortic Stenosis
Lead sponsor: Opsens, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
Primary purpose: OTHER

Brief summary: The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject has a severe symptomatic AS undergoing a TAVI procedure
3. Subject with a THV for which rapid pacing is considered necessary during valve implantation
4. Subject agrees to participate in the study and is able to sign the informed consent form

Exclusion Criteria:

1. Failure to provide signed informed consent
2. Extremely horizontal aorta (aortic root angle ≥70°)
3. Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
4. Inability to receive full anticoagulation during the TAVI procedure
5. Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.

Primary outcomes:
measure: Percentage of patients with effective rapid pacing run
timeFrame: during surgery
Secondary outcomes:
measure: Presence of major complications (safety)
timeFrame: during surgery
measure: Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)
timeFrame: during surgery
measure: Percentage of patient with valve advancement to intended position (mechanical efficacy)
timeFrame: during surgery
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Josep Rodés-Cabau, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00435383: Comparing Oxygen Saturation in Post Anesthesia Care Unit After Different Methods of Pain Relief
Official title: Oxygen Saturation During Transfer From Operating Room to Post Anesthesia Care Unit After Current Anesthesia Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptorchidism
Keywords: Caudal Block
Oxygen Saturation
Uni or Bilateral Orchidopexy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2007-02-15
Enrollment: 42
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children scheduled for elective uni or bilateral orchidopexy.

Brief summary: To determine the which method of pain relief is better after current anesthesia care.

Detailed description: We hypothesized that in children, the current anesthesia care (combined light general anesthesia and caudal analgesia) may decrease incidence of intra and or postoperative de-saturation( SaO2 \< %95), the need of oxygen during child's transport to the PACU and during his stay in the recovery room, compared with children who receive intravenous narcotics for intra and postoperative pain relief.

Eligibility criteria: Inclusion Criteria:

* Healthy children
* ASA physical status 1 or 2
* 1-6 yr old
* Scheduled for elective uni or bilateral orchidopexy

Exclusion Criteria:

* Children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas,Anesthesiology Department
state: Texas
Study officials:
affiliation: University of Texas, Houston, Texas
name: Samia Khalil, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381483: Vitamin A in Brown Fat Activity
Official title: The Role of Vitamin A in Brown Fat Activity and Energy Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brown Adipose Tissue
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical studies, however the role of retinoids in human brown fat physiology and energy metabolism remains elusive. This study aims to identify a possible association between retinoid metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic profile of white and brown neck fat biopsies at room temperature and cold conditions in a subset of the study participants. More detailed molecular studies (involving other potential browning markers) will also be performed in adipocytes derived from human SVC.

The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects will be repeatedly exposed to cold and circulating retinoid levels and other plasma parameters will be measured at various time points.


Eligibility criteria: Inclusion Criteria:

* Age 20 - 45 years.
* Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese)

Exclusion Criteria:

* Endocrine (except hyperlipidemia), cardiovascular (except hypertension), liver, kidney, inflammatory bowel, rheumatic, oncologic disease or any other chronic condition.
* Medication for any of the above mentioned conditions.
* Pregnancy
* Metallic implants that are not MRI compatible

Primary outcomes:
measure: Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity
timeFrame: 6 years
Secondary outcomes:
measure: Analyses of potential BAT or browning markers in humans
timeFrame: 6 years
measure: Association between BAT activity and energy expenditure
timeFrame: 6 years
measure: Identification of new factors related to brown fat function
timeFrame: 6 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Florian Kiefer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulterer OC, Niederstaetter L, Herz CT, Haug AR, Bileck A, Pils D, Kautzky-Willer A, Gerner C, Kiefer FW. The Presence of Active Brown Adipose Tissue Determines Cold-Induced Energy Expenditure and Oxylipin Profiles in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa183. doi: 10.1210/clinem/dgaa183.
Clinical trial NCT05511883: Periosteal Chondrosarcoma: a Single Institution Experience
Official title: Periosteal Chondrosarcoma: a Single Institution Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periosteal Chondrosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients considered eligible will be included in the study, after providing a written informed consent.

Since we will include cases of several decades ago, and due to the high incidence of mortality of the disease under investigation, it would be possible that some eligible subjects will be deceased.

Brief summary: Periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones.

Periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the fourth decade (2).

It has a reported incidence of local recurrences of 13-28% and a low metastatic potential, with distant recurrences occurring mostly in lungs (3).

Contrary to conventional chondrosarcomas, grading of periosteal chondrosarcomas seems not to predict prognosis. IDH1 and IDH2 mutations, characteristics of central chondromas/chondrosarcomas, have been also found in a subset of periosteal chondrosarcomas (1, 4).

These observations are based on the results from smaller series of cases (1, 5, 6), although the impact of histopathological characteristics on survival, local recurrence and metastases should be assessed in larger series of cases.

The aim of the present study is to review all the cases with a diagnosis of primary periosteal chondrosarcoma treated at the Rizzoli Institute from 1900 up to 31 December 2019, retrospectively.

The study will exam all the clinical, radiological, and histological features of this tumor with regard importance of medullary involvement, the IDH1/2 gene status, the types of treatment, the status of surgical margins, the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.


Eligibility criteria: Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Dec 2019
* Diagnosis of peristeal chondrosarcoma
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

* Patients with histological diagnosis different from periosteal chondrosarcoma.

Primary outcomes:
measure: Periosteal Chondrosarcoma: a single institution experience
timeFrame: act baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS- Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT00274183: Nonalcoholic Fatty Liver Disease in Taiwanese Children
Official title: Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2006-01-10
Enrollment: 614
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese children will be enrolled from elementary school and high school in Taiwan

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.

Detailed description: \[Study Subjects\] Obesity was defined as the BMI value \> 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.

\[Data Collection\] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. BMI was calculated as body weight (kg)/ height (m2).

In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.

\[Liver Ultrasonography\] All participants underwent an ultrasonographic study of the liver performed by one operator.

NAFLD was defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.

Eligibility criteria: Inclusion Criteria:

* diagnosis of fatty liver

Exclusion Criteria:

* other hepatic diseases

Primary outcomes:
measure: non-alcoholic fatty liver disease
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yu-Cheng Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin YC, Chang PF, Chang MH, Ni YH. Genetic variants in GCKR and PNPLA3 confer susceptibility to nonalcoholic fatty liver disease in obese individuals. Am J Clin Nutr. 2014 Apr;99(4):869-74. doi: 10.3945/ajcn.113.079749. Epub 2014 Jan 29.
citation: Lin YC, Chang PF, Chang MH, Ni YH. A common variant in the peroxisome proliferator-activated receptor-gamma coactivator-1alpha gene is associated with nonalcoholic fatty liver disease in obese children. Am J Clin Nutr. 2013 Feb;97(2):326-31. doi: 10.3945/ajcn.112.046417. Epub 2012 Dec 26.