louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00690144: High-fidelity Simulation in Health Care Education
Official title: Prospective Study Focusing on Impact of High-fidelity Simulation in Health Care Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: simulation
medical education
performance of clinical reasoning and skills
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.

Detailed description: High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.

Eligibility criteria: Inclusion Criteria:

* healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians.

Exclusion Criteria:

* any trainees unwilling to receive simulation-based training

Primary outcomes:
measure: performance of clinical reasoning and skills in simulated settings
timeFrame: before and after the simulation-based training
Secondary outcomes:
measure: clinical performance of reasoning and skills
timeFrame: before and after the simulation-based training
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Matthew Huei-Ming Ma, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01843244: Plethysmography as a Useful Intraoperative Monitor
Official title: Plethysmography as a Useful Intraoperative Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: plethysmography
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 15
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: Patient scheduled for surgery that will have both an arterial catheter and a pulmonary artery catheter as standard of care

Brief summary: Data from both the traditional invasive cardiac monitors and the Nonin will be collected simultaneously. The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Detailed description: After obtaining written consent to participate, the standard of care arterial line and PA catheter will be placed pre-operatively. The investigators will attach the Nonin pulse oximeter, as a second pulse oximeter probe, to patients undergoing surgical procedures which already require invasive cardiac monitors (arterial line, pulmonary artery catheter, etc). Data from both the traditional invasive cardiac monitors and the Nonin pulse oximeter will be collected as electronic files. Once both files are compiled they will be de-identified.

The investigators will also record medications and IV fluids given during surgery.

The Nonin Pulse Oximeter is clinically marketed for this indication

The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older Patient scheduled for surgery that will have both an arterial catheter and a pulmonary artery catheter as standard of care Informed consent

Exclusion Criteria:

* Only the above inclusion criteria apply

Primary outcomes:
measure: waveform variation of the Nonin pulse oximeter compared with that of the arterial catheter
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: UVA Anesthesiology
name: Robert Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269744: Proactive Outreach With FIT
Official title: A Randomized, Multi-site Trial to Boost Colorectal Cancer Screening Rates Through Proactive Outreach and Navigation in Federally Qualified Health Centers in Brooklyn
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.


Eligibility criteria: Inclusion Criteria:

Patients

* Men and women aged 45-75
* Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites.
* Due or overdue for CRC screening.
* Medical visit of any type at clinic in past year.

Providers

* Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees)
* Provide care to CRC screen-eligible patients

Exclusion Criteria:

* Age younger than 45 years old or greater than 75 years old
* Up-to-date with colorectal cancer screening:
* History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy
* In hospice care
* Patients 66 years or older living long-term in an institution or with advanced illness
* No address or phone number on file

Providers

• No longer employed at an included clinic site

Primary outcomes:
measure: Proportion of Participants who Complete FIT Test by Month 6
timeFrame: Up to Month 6
Secondary outcomes:
measure: Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: Brooklyn
country: United States
facility: Community Health Care Network of New York
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aasma Shaukat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066844: Navigator vs Standard Needle Injection for Hip
Official title: Phase II Study of Navigator vs Standard Needle Injection for Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Pain Etiology Unknown
Keywords: Hip Pain
Hip Injection
Hip Fracture
Hip Bursitis
Hip Arthritis
Hip Sciatica
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-20
Enrollment: 40
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: The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.


Eligibility criteria: Inclusion Criteria:

* Males and females, ≥18 years of age, of any race or ethnicity;
* Capable of completing self-administered questionnaires;
* Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months;
* Candidate for a hip injection;
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee.
* Subjects are able to understand and speak English

Exclusion Criteria:

* History of intra-articular injection within the last 3 months prior to the injection procedure;
* Complex regional pain syndrome;
* History of prior hip surgery;
* History of substance abuse;
* Known history of hypersensitivity to local anesthetics of the amide type;
* Contraindicated for Celestone (betamethasone sodium phosphate);
* Contraindicated for Lidocaine Hydrochloride;
* Is a prisoner or ward of the state;
* Are unable to meet the treatment and follow up protocol requirements.

Primary outcomes:
measure: Injection Pain as measured by VAS for both treatment groups
timeFrame: From 1 week to 12 weeks post-injection
Secondary outcomes:
measure: Global Patient Satisfaction
timeFrame: From 1 week to 12 weeks post-injection
measure: Drug Preparation Time
timeFrame: From 1 week to 12 weeks post-injection
measure: Hip Pain and Function
timeFrame: From 1 week to 12 weeks post-injection
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Brian Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871944: Effectiveness of Kaltenborn End Range Joint Mobilization Technique and Post FacilitationStretch in Shoulder Impingement Syndrome
Official title: Effectiveness of Kaltenborn End Range Joint Mobilization Technique and Post Facilitation Stretch in Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
Collaborators: name: Al Nafees Medical Hospital, Islamabad
name: National Institute of Rehabilitation Medicine, Islamabad, Pakistan
First posted: 2023-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be formed. one group will receive joint mobilization technique and other will get post facilitation stretch technique
Primary purpose: TREATMENT

Brief summary: This study is a experimental one to observe the efficacy of joint mobilization and post facilitation techniques in shoulder impingement syndrome

Detailed description: his study is a experimental one to observe the efficacy of Kalternborn end range joint mobilization and post facilitation techniques in shoulder impingement syndrome. Goniometer, shoulder disability index will be the tool used for evaluation

Eligibility criteria: Inclusion Criteria:

* Both male and female
* Age 25 to 45
* Diagnosed Rotator cuff impingement from ortho, neuro and musculoskeletal department
* Hawkin kennedy test positive
* Neer's test positive
* Jobe's test positive

Exclusion Criteria:

* Cervical spine disorder
* Fractures
* Major upper limb surgery
* Tumor or wound
* Diagnosed acromial malformations

Primary outcomes:
measure: Goniometer
timeFrame: 4 weeks
measure: Shoulder Pain and Disability Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Al Nafees Medical Hospital, Islamabd
state: Federal
Study officials:
References:
Clinical trial NCT00937144: Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Sickle Cell Anemia
Keywords: endothelial function
endothelial progenitor stem cells
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2009-07-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators would like to study the endothelial function in sickle cell patients without pulmonary hypertension in an in vivo method during a steady state condition before and after sildenafil treatment for 1 month, and to study the effects of this nitric oxide donor by measuring the Flow Mediated Dilatation, by measuring endothelial progenitor stem cells colonies, and by measuring the effect of therapy on markers of inflammation (cell adhesion molecules and cytokines).


Eligibility criteria: Inclusion Criteria:

* patients with sickle cell anemia

Exclusion Criteria:

* patients with sickle cell anemia during acute crisis

Primary outcomes:
measure: endothelial function before and after viagra treatment to patients with sickle cell anemia without pulmonary hypertension
timeFrame: January 2009 till January 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Baruch Padeh Poria Medical Center
state: Lower Galilee
Study officials:
References:
Clinical trial NCT04516044: Effect of Videogames on Real-life Triage Patterns
Official title: Long-term Followup of Effects of Customized Videogames on Physician Triage Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Physician's Role
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2020-08-17
Enrollment: 686
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 65 who presented after a moderate-severe injury to a non-trauma center in the US during 2016-2018.

Brief summary: In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). This study will now assess long-term outcomes for physicians enrolled in those two trials to evaluate the effect of the interventions on triage practices for trauma patients who presented initially to non-trauma centers in the US between December 2016 and November 2018.


Eligibility criteria: Inclusion Criteria:

* Participated in two prior clinical trials (Physician)
* ≥65 years old (Patient)
* enrolled in Medicare fee-for-service
* sustained a moderate-severe injury (i.e. ISS \[injury severity score\] \>15) (Patient)
* treated by physician enrolled in prior clinical trials (Patient)

Exclusion Criteria:

* Did not participate in two prior clinical trials (Physician)
* \<65 years old (Patient)

Primary outcomes:
measure: Number of patients triaged to trauma centers
timeFrame: 1 year following the intervention
Secondary outcomes:
measure: Number of moderate-severely injured patients who die 30-days after initial evaluation
timeFrame: 1 year following the intervention
measure: Frequency of resources used for patients with moderate-severe injuries treated by participants
timeFrame: 1 year following intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Deepika Mohan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohan D, Farris C, Fischhoff B, Rosengart MR, Angus DC, Yealy DM, Wallace DJ, Barnato AE. Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial. BMJ. 2017 Dec 12;359:j5416. doi: 10.1136/bmj.j5416.
citation: Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
Clinical trial NCT02741544: Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])
Official title: Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Second primary cancers
Cataracts
Newly-diagnosed multiple myeloma
Revlimid capsules
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among patients with newly-diagnosed multiple myeloma (hereinafter referred to as "NDMM") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).

Brief summary: To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.


Eligibility criteria: Inclusion Criteria:

* Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03079544: Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients
Official title: Social Media-based Patient Education and Active Self-report on Incidence and Outcomes of Adverse Events in Natural Killer/T-cell Lymphoma (NK/TCL) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 665
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with the diagnosis of NK/TCL treated out of clinical trials are candidators for this study.

Brief summary: The purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/T-cell lymphoma, nasal type, who are treated outside of clinical trials in China.

Detailed description: Extranodal natural killer/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma with relatively high incidence in China. L-asparaginase based chemotherapy are widely used with Chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. However, most patients were treated out of clinical trials in China. Therefore the real incidence of adverse events and treatment outcomes are largely unknown. This study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
* Treated with at least one cycle of L-asparaginas or Pegaspargase based chemotherapy.
* Signed Informed consent.

Exclusion Criteria:

* patients who are enrolled in any other clinical trials.
* Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.

Primary outcomes:
measure: overall survival
timeFrame: 2-year
Secondary outcomes:
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years
measure: Progression free survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lymphoma House086
state: Beijing
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua hospital, Shanghai Jiao Tong University of Medicine
name: Rong Tao, MD
role: STUDY_CHAIR
References: