louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02126150: United Coronary Biobanks
Official title: United CORoNary Biobanks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Infarction
Stable Angina
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
First posted: 2014-04-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that undergo coronary catheterization for any reason are eligible to enroll in the study.

Brief summary: The UNICORN consists of two collaborating biobanks, one in Utrecht and one in Singapore. From these two sites we include all patients who undergo a coronary catheterization for any reason.

At the moment of catheterization we draw blood, which will be stored in a biobank and we collect clinical characteristics. Patients are followed-up for 5 years for the occurrence of major cardiovascular events.

By including from two sites in the world we include 4 major ethnic groups: Caucasians, Chinese, Indians and Malays. We aim at including at least 2000 patients per ethnic group.

Our hypothesis is that there are differences in the risk factor burden, clinical presentation of CAD, and biochemical patterns in the blood among the ethnic groups.

Furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary angiography

Exclusion Criteria:

* \< 21 years of age
* Hemoglobin levels \<7 g/dL in women, or hemoglobin levels \<8 g/dL in men

Primary outcomes:
measure: All-cause death
timeFrame: 5 years
Secondary outcomes:
measure: Major cardiovascular events
timeFrame: 5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT02122250: Web-based Support for People With Type 2 Diabetes
Official title: Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Health literacy
web intervention
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 1041
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.

This study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.


Eligibility criteria: Inclusion Criteria:

* Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.

Exclusion Criteria:

* Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.

Primary outcomes:
measure: user engagement
timeFrame: This will be measured by intervention completion rates
Secondary outcomes:
measure: Patient enablement
timeFrame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
measure: Website satisfaction
timeFrame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
measure: Physical activity attitudes and intentions
timeFrame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
measure: Diabetes and Physical activity knowledge
timeFrame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Other outcomes:
measure: Single item: whether you would recommend the website to others
timeFrame: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
Locations:
Study officials:
affiliation: University of Southampton
name: Lucy Yardley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810550: Carotid Ultrasound in the Evaluation of Heart Failure
Official title: Carotid Ultrasound in the Evaluation of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Cardiomyopathy
Heart Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Detailed description: Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Eligibility criteria: Inclusion Criteria:

* LVEF 40% or less

Exclusion Criteria:

* Prior diagnosis of coronary or carotid obstructive atherosclerosis

Primary outcomes:
measure: Diagnostic accuracy for severe CAD
timeFrame: 1 Day
Secondary outcomes:
measure: Diagnostic accuracy for significant CAD
timeFrame: 1 Day
Other outcomes:
Locations:
Study officials:
References:
citation: Reynolds HR, Steckman DA, Tunick PA, Kronzon I, Lobach I, Rosenzweig BP. Normal intima-media thickness on carotid ultrasound reliably excludes an ischemic cause of cardiomyopathy. Am Heart J. 2010 Jun;159(6):1059-66. doi: 10.1016/j.ahj.2010.03.026.
Clinical trial NCT04800250: Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study
Official title: Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control
Primary purpose: TREATMENT

Brief summary: Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft


Eligibility criteria: Inclusion criteria:

* Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions)
* Patient non-smoker
* Patient affiliated to social security
* Patient signed informed consent.

Exclusion criteria:

* Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy
* Patient with severe hemorrhinopathy
* Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants
* Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months.
* Patient with contraindication to necessary and pre-, per- or post-operative treatments
* Follow-up of the patient seemed difficult by the investigator
* Patient with insufficient oral hygiene incompatible with oral surgery

Primary outcomes:
measure: Mean root coverage obtained with both techniques
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative pain with both techniques
timeFrame: 6 months
measure: Postoperative complications with both techniques
timeFrame: 10 days
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Provence Alpes Cote d'Azur
Study officials:
References:
Clinical trial NCT02930850: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Official title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Healthy
Pediatric ALL
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 447
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Detailed description: The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

Eligibility criteria: Inclusion Criteria:

* Age: Greater than one month
* Weight: Greater than or equal to 3kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
* Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Primary outcomes:
measure: Accuracy of hemoglobin measurement
timeFrame: Up to 2 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Site 4
state: California
city: Burbank
country: United States
facility: Site 5
state: California
city: Irvine
country: United States
facility: Site 2
state: California
city: Lake Forest
country: United States
facility: Site 7
state: California
city: National City
country: United States
facility: Site 3
state: California
city: Torrance
country: United States
facility: Site 6
state: California
city: Charlotte
country: United States
facility: Site 1
state: North Carolina
Study officials:
References:
Clinical trial NCT00247650: Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy
Official title: Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-02
Enrollment: 190
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer


Eligibility criteria: Inclusion Criteria

* Postmenopausal women
* Newly diagnosed with non metastatic breast cancer
* Candidate for mastectomy or breast-conserving surgery

Exclusion Criteria

* Patients with invasive tumors
* Patients receiving anti-cancer treatment
* Patients who have undergone surgery

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Clinical response at 24 weeks
Secondary outcomes:
measure: Clinical response at 16 weeks
measure: Clinical benefit at 16 weeks
measure: Clinical benefit at 24 weeks
measure: Rate of breast conserving surgery in both arms
measure: Rate of complete pathological response
measure: Biomarkers
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Granby
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Victoriaville
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06400550: Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
Official title: Identification of Metabolic Phenotypes Associated With Melanoma Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma (Skin)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age with a suspected malignant melanoma

Brief summary: The goal of this study is to observe metabolic features associated with human melanoma tumors.

Detailed description: This is a single center, correlative study designed to assess metabolic features of melanoma tumors in patients. The study will involve the collection of melanoma tissue at the time of surgical biopsy or excision. All samples will be assessed by mass spectrometry for metabolomic analysis. A subset of patients will have received \[U-13C\]glucose infusions which will be utilized for isotope tracing metabolic analysis. Relevant clinical data (eg survival, metastasis) will be correlated with metabolic findings.

Eligibility criteria: Inclusion Criteria:

* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.
* Subjects of all races and ethnic origins over age 18.

Exclusion Criteria:

* Not a surgical candidate
* Poorly controlled diabetes

Primary outcomes:
measure: Glucose Utilisation in the TCA cycle
timeFrame: 5 years
Secondary outcomes:
measure: Relapse free survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Development of Lymph Node or Distant Metastasis
timeFrame: 5 years
Other outcomes:
measure: Tumor Metabolomic and Lipidomic Profiling
timeFrame: 5 years
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jennifer Gill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00451490: The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Official title: The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: agomelatin
prozac
heart rate variability
major depression
sleep
depressive symptoms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.

Detailed description: Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.

Eligibility criteria: Inclusion Criteria:

* Asian patients
* Male or female
* 18 to 65 years outpatients
* DSM-IV-TR criteria for Major Depressive Disorder

Exclusion Criteria:

* Patients with cardiac conditions and other physical conditions contraindicated for drug study
* Shift worker
* Patients known to be non-responders to fluoxetine treatment
* Pregnancy, or breastfeeding

Primary outcomes:
measure: the Pittsburgh Sleep Quality Index
measure: the Leeds Sleep Evaluation Questionnaire
Secondary outcomes:
measure: heart rate variability
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Univetsity Hospital
name: Mei-Chih Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01435590: Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 180
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: OBJECTIVE: to compare endocervical brushing with endocervical curettage with respect to diagnostic and patient discomfort.

METHOD: women referred to colposcopy because of abnormal Papanicolaou tests will be randomized to endocervical sampling with either a metal curette (endocervical curettage -ECC) or and endocervical brush. All samples will be submitted for histological study.


Eligibility criteria: Inclusion Criteria:

* French-speaking
* 21 years or older
* Attending our colposcopy clinic
* Need for endocervical evaluation
* Full autonomy or capacity to understand the procedures

Exclusion Criteria:

* Pregnancy
* Absence of uterus
* History of DES exposure in utero

Primary outcomes:
measure: Specimen adequacy
timeFrame: 09/2011 - 05/2012 (1 year)
Secondary outcomes:
measure: Patient discomfort
timeFrame: 09/2011 to 05/2012 (8 months)
Other outcomes:
Locations:
Study officials:
References:
citation: Undurraga M, Catarino R, Navarria I, Ibrahim Y, Puget E, Royannez Drevard I, Pache JC, Tille JC, Petignat P. User perception of endocervical sampling: A randomized comparison of endocervical evaluation with the curette vs cytobrush. PLoS One. 2017 Nov 6;12(11):e0186812. doi: 10.1371/journal.pone.0186812. eCollection 2017.
Clinical trial NCT04942990: The Effectiveness of Calistenic Exercise Training in Adolescents
Official title: The Effectiveness of Calistenic Exercise Training in Adolescents Receiving Online Education During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Development
Keywords: Adolescent
Teleconference
exercise training
calisthenic exercise
physical activity
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 38
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: The aim of this study is to examine the effectiveness of calisthenic exercise training applied via video chat application on physical activity, physical fitness, quality of life and sleep, and anxiety and depression levels in adolescents during distance education. Material and methods: In our study, 38 adolescents were randomly divided into two equal groups as exercise training group and control group. Calisthenic exercise training was given to the exercise training group for eight weeks, three days a week, via video chat application and under the supervision of a physiotherapist. The control group was evaluated before and after the study period. Physical activity levels of individuals; International Physical Activity Scale, quality of life; Children's Quality of Life Scale, anxiety depression levels; Beck Anxiety Scale, Reynolds Depression Scale and sleep quality were evaluated with Pittsburg Sleep Quality Index.


Eligibility criteria: Inclusion Criteria:

* Healthy adolescent children

Exclusion Criteria:

* Individuals with a disease that could prevent them from doing our exercise training were not included in the study.

Primary outcomes:
measure: The levels of physical activity
timeFrame: 8 weeks
measure: sleep quality
timeFrame: 8 weeks
measure: quality of children's lives
timeFrame: 8 weeks
measure: the level of anxiety
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References: