louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04439643: Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
Official title: Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Elucid Bioimaging Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2020-06-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reverse chronological, all-comers, design, adjusted for demographic factors

Brief summary: Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.

Detailed description: Develop time-to-event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as last known well dates.

Eligibility criteria: Inclusion Criteria:

* Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
* Subject must have been ≥ 18 years of age at the time of the CCTA

Exclusion Criteria:

* Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
* CCTA taken less than 3 months after deployment of new scanner
* Subject with insufficient CCTA image quality

Primary outcomes:
measure: Time to adverse outcome
timeFrame: >= 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Elucid Bioimaging Inc.
name: Andrew J. Buckler, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05141643: Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People with Pancreatic Cancer
Official title: 18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Cancer
pancreatic ductal adenocarcinoma
18F-FAC
Memorial Sloan Kettering Cancer Center
21-442
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 30
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 study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically-confirmed (confirmed at MSKCC) PDAC
* Patients must be ≥ 18 years old
* Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
* Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
* Karnofsky Performance Status ≥70%.
* Life expectancy ≥3 months.
* A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.

Exclusion Criteria:

* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
* Women who are pregnant or breast-feeding.

Primary outcomes:
measure: Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
timeFrame: Baseline
Secondary outcomes:
measure: changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schoder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06514443: Barriers and Faciliators for Physical Activity in People With RMDs
Official title: Exploration of Country-specific Barriers and Facilitators for the Implementation of Physical Activity According to the EULAR Physical Activity Recommendations for People With Rheumatic Musculoskeletal Diseases in Four Different European Countries; the COPA Project
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Rheumatoid Arthritis
Axial Spondyloarthritis
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Acibadem University
name: Leiden University Medical Center
name: Sorbonne University
First posted: 2024-07-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with osteoarthritis, rheumatoid arthritis or axial Spondyloarthritis living in Turkey, the Netherlands, France or Switzerland

Brief summary: The aim of this project is to systematically survey and explore barriers and facilitators for the implementation of physical activity according to the physical activity recommendations of the European Alliance of Associations for Rheumatology on country specific (e.g., environmental, cultural, organization and system) level. A questionnaire to explore/identify these barriers and facilitators in the survey, will be developed through literature search, interviews with multiple stakeholders (i.e., patients with inflammatory arthritis or osteoarthritis and physical therapists) and experts in the field in four different European countries (i.e., Turkey, Switzerland, the Netherlands and France).

Additionally, in Switzerland only, the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors on personal level, will be translated into the German language. Aim is to evaluate the validity and reliability of the IFAB Questionnaire in the German-speaking population with axial Spondyloarthrits, and to perform a cultural adaptation if necessary at the same time.


Eligibility criteria: Inclusion Criteria:

* adults being 18years or older
* diagnosis of osteoarthritis, rheumatoid arthritis or axial Spondyloarthritis
* the cognitive and linguistic competencies to answer the survey

Exclusion Criteria:

* having a rheumatological or musculoskeletal disease other than described
* any communication problems

Primary outcomes:
measure: barriers and facilitators for physical activity
timeFrame: September-December 2024
Secondary outcomes:
measure: reliability of the IFAB
timeFrame: September-December 2024
measure: validity of the IFAB
timeFrame: September-December 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02462343: Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
Official title: Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: All measurements are performed on two consecutive days at the beginning of a pulmonary rehabilitation program in a randomized cross-over study design. On the first day, each patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk test. On the second day each patient performs the test that was not performed on the first day. All walk tests are performed by the same investigator on the same track and time of day, following the 2002 guidelines of the American Thoracic Society.

Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are recorded at rest after 10 minutes of sitting.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of chronic obstructive lung disease stage III or IV according to the Global Initiative for chronic Obstructive Lung Diseases definition
* ability to read and understand the German language and study procedures.
* written informed consent

Exclusion Criteria:

* severe acute exacerbation of chronic obstructive lung disease
* severe respiratory failure (partial Oxygen pressure at rest lower than 55 millimeter mercury)
* non compliance to the study protocol.

Primary outcomes:
measure: oxygen desaturation
timeFrame: up to 6 minute walk test
Secondary outcomes:
measure: heart rate
timeFrame: during 2 minute walk test and 6 minute walk test
measure: perceived exertion for dyspnea and leg fatigue
timeFrame: during 2 minute walk test and 6 minute walk test
Other outcomes:
Locations:
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Klaus Kenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739943: Remote Monitoring of Respiratory Health
Official title: Remote Monitoring of Respiratory Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Respiratory Disease
Asthma
Copd
Keywords: digital health
mobile monitoring
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be given access to one or more devices or smartphone/tablet applications. They will then be followed with surveys as well as data from chart review to see how use of one or more elements for remote monitoring may affect their quality of life and overall care.
Primary purpose: PREVENTION

Brief summary: Recently, interest in ways to monitor and care for patients remotely has significantly increased due to concerns for infection control as well as a way to increase access to regular clinic visits that may be limited for socioeconomic and geographic reasons. However, remote care can be limited by a lack of objective data to help guide clinical care. With respect to respiratory disease, caring for patients remotely may be enhanced by the ability of patients to monitor at home such things as vital signs, lung sounds, and lung function by spirometry. Enhanced methods to follow symptoms and track medication compliance may also be beneficial. These enhancements could improve care and quality of life both for persons with acute respiratory illnesses and those with chronic respiratory disease (such as asthma or COPD).

The purpose of this study is to develop and study methods for patients to monitor their respiratory health at home and make that data available to medical providers to improve their care.


Eligibility criteria: Inclusion Criteria:

* age 1 month or older with a diagnosis of chronic respiratory disease (ex. asthma, COPD), an acute respiratory illness or a healthy volunteer
* able to consent or assent with parental consent

Exclusion Criteria:

* people who do not consent
* significant cognitive impairment
* non-English speaking

Primary outcomes:
measure: PROMIS-10 survey
timeFrame: Up to 2 years
measure: Asthma Control Test (ACT)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University, Sean N. Parker Center for Allergy and Asthma Research
name: Sharon Chinthrajah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00264043: The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.
Official title: Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.

Detailed description: This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.

Eligibility criteria: Inclusion Criteria:

* Unstable angina pectoris (Braunwald classification B \& C, I-II-III, native vessels)
* or lesion located in the SVG;
* Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
* The vessel diameter to place the AngioGuard™ device in must be \> 3 and \< 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
* Target lesion stenosis is \>50% and \<100% (TIMI 1).

Exclusion Criteria:

* A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
* More than one coronary artery is 100% occluded;
* Patient has unprotected left main coronary disease with \> 50% stenosis;
* Patient has an ostial target lesion;
* Significant (\>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
* Ejection fraction \<30%;
* Totally occluded vessel (TIMI 0 Level).

Primary outcomes:
measure: clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
timeFrame: 1 month
Secondary outcomes:
measure: successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
timeFrame: post-procedure
measure: overall survival rates
timeFrame: 1 month and 6 months
measure: device evaluation
timeFrame: post-procedure
Other outcomes:
Locations:
city: Siegburg
country: Germany
facility: Herzzentrum Siegburg GMBH
Study officials:
affiliation: Herzzentrum Siegburg GMBH
name: Eberhard Grube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968343: Trichotillomania: Group Cognitive-Behavioral Therapy
Official title: Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichotillomania
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).


Eligibility criteria: Inclusion Criteria:

* Patients having been diagnosed with trichotillomania according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria; being at least 18 years of age; and having had four or more years of schooling.

Exclusion Criteria:

* Patients that having been diagnosed with trichotillomania according to DSM-IV criteria; having less of 18 years of age; and having less of four years of schooling.
* Patients with a history of suicidal ideation,
* Patients with any clinical pathology requiring emergency treatment at admission,
* Patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function,
* those with a psychotic disorder,
* those currently being treated with psychotropic drugs,
* those with any DSM-IV axis II diagnosis,
* those who scored ≤ 2 on the MGH-HPS in an initial screening.

Primary outcomes:
measure: Massachusetts General Hospital (MGH) Hairpulling Scale (HPS)
timeFrame: 22 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 22 weeks
Other outcomes:
measure: Social Adjustment Scale (SAS) Self-Report (SR)
timeFrame: 22 weeks
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Psiquiatria da Universidade de São Paulo
Study officials:
References:
citation: Toledo EL, De Togni Muniz E, Brito AM, de Abreu CN, Tavares H. Group treatment for trichotillomania: cognitive-behavioral therapy versus supportive therapy. J Clin Psychiatry. 2015 Apr;76(4):447-55. doi: 10.4088/JCP.13m08964.
Clinical trial NCT06579443: Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
Official title: Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: Robotic IBD surgery
Laparoscopic IBD surgery
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for inflammatory bowel disease

Brief summary: To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over
* Undergoing IBD surgery using MIS (minimally invasive surgery) techniques
* Histological/radiological evidence of inflammatory bowel disease

Exclusion Criteria:

* Planned open surgical approach
* Lacks capacity to provide informed consent

Primary outcomes:
measure: To see if robotic surgery is technically feasible for patients with inflammatory bowel disease measured during intra-operative procedure that includes: estimated blood loss in mL.
timeFrame: 12 months
measure: Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.
timeFrame: 12 months
measure: Docking of robotic arm in robotic surgery using number of times the docking was done with start and end docking time in HH:MM.
timeFrame: 12 months
measure: Operative time using time of surgery performed in HH:MM.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Abhilasha Patel
state: West Midlands
Study officials:
References:
Clinical trial NCT06103643: Simulation Based Emergency Brex Birth Management Training
Official title: Simulation-based Emergency Brex Birth Management Training Impact on Students'Self Confidence and Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of SIMULATION-BASED EMERGENCY BREX BIRTH MANAGEMENT TRAINING IMPACT ON STUDENTS' SELF-CONFIDENCE AND COMPETENCE.

Detailed description: Hypotheses H01; There was no difference between the students'self-confidence and competence of the simulation-based emergency brex birth management training group and students'self-confidence and competence score control group.

The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Breech birth management training will be given by the responsible investigator, and then one of the groups separated by randomization will perform emergency breech birth on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Eligibility criteria: Inclusion Criteria:

- Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

-

Primary outcomes:
measure: Self-Confidence/Efficacy Scale in Patient Intervention
timeFrame: immediately before simulation and immediately after the training 2 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Sümeyye BAL
role: STUDY_DIRECTOR
References: