louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04577196: Improving Situational Awareness Before Acute Care
Official title: Impact of Information Processing Via a Dashboard on the Situational Awareness of the Trauma Team Prior to the Management of a Critical Patient: an Experimental Simulation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Trauma
Keywords: Simulation training
Non-technical skills
Data processing
Trauma team briefing
Situational awareness
Cognitive support
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians, residents and nurses from the Grenoble Alpes University Hospital volunteering to participate.

Brief summary: This study aims to assess the impact on the trauma team's situational awareness of using a dashboard to synthesize and disseminate available information on a critical patient incoming to the trauma center.

Detailed description: This trial will be carried out at the Grenoble Alpes University Hospital's simulation center. Volunteer professionals will run scenarios simulating the information transmission chain "pre-hospital team - trauma leader - trauma team" just prior to the admission of a critical patient to the trauma center. In each scenario, the trauma leader will be alerted by phone that a patient is being managed by a pre-hospital medical team and is about to be transferred to the trauma center. The trauma leader will have to synthesize and disseminate the available information to the trauma team (composed of a junior physician, a resident and a nurse). Depending on the allocation group, the transmission chain will be supported or not by a specific trauma dashboard. The scenario will be discontinued at the end of this handover and before the patient's arrival.

Eligibility criteria: Inclusion Criteria:

* Physicians, residents and nurses from the Grenoble Alpes University Hospital volunteering to participate.

Exclusion Criteria:

* Prior knowledge of the study scenarios
* Study investigator

Primary outcomes:
measure: Trauma team situational awareness
timeFrame: immediately after the end of the information transmission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06765096: Impact of Virtual Reality Model for Pelvic Floor Anatomy on Users' Educational Level and Experience
Official title: Impact of Virtual Reality Model for Pelvic Floor Anatomy on Users' Educational Level and Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the impact of virtual reality (VR) model for pelvic floor anatomy on users' educational level and experience.

Detailed description: Virtual reality (VR) has gained significant attention as an educational tool in various fields, including science and health education. Its capacity to create immersive, interactive environments allows students to explore complex, three-dimensional structures, enhancing visualization and understanding of abstract or intricate concepts. VR can bridge gaps in traditional education by offering experiences that are otherwise challenging to replicate in conventional classroom settings, such as real-time manipulation of anatomical models.

In health sciences, VR is particularly valuable for anatomy education. Studies have shown that VR's interactive and immersive nature fosters deeper comprehension, especially in understanding spatial relationships within anatomical structures. A VR model for pelvic floor anatomy could therefore serve as a powerful tool, allowing users to engage in a hands-on learning experience that enhances knowledge retention and user satisfaction.

Research indicates that VR may improve educational outcomes not only through knowledge acquisition but also by stimulating students' motivation and positive attitudes toward learning. A recent study has found that VR helped students develop problem-solving and visualization skills, which are crucial for disciplines requiring spatial awareness, such as anatomy. However, while VR shows promise, questions remain about its effectiveness compared to traditional educational methods, especially in specialized fields like pelvic floor anatomy.

Eligibility criteria: Inclusion Criteria:

* Physical therapy undergraduate, graduate, and postgraduate students, as well as professionals.
* Participants must be physically able to wear and interact with a VR headset

Exclusion Criteria:

* Lack of Anatomy Background.
* Prior Extensive VR Experience in Anatomy.
* Severe Motion Sickness or Visual Disorders.

Primary outcomes:
measure: A self-structured questionnaire
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Amel Mohamed Yousef, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01247896: Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
Official title: A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Primary outcomes:
measure: Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements
timeFrame: 8 weeks
measure: The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit
timeFrame: 48 hour
Secondary outcomes:
measure: PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2),
timeFrame: 48 hour
measure: Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC)
timeFrame: Day 1 for Periods 1 and 2, for Cohort 3.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cobbina E, Lee MR, Leggio L, Akhlaghi F. A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers. Clin Pharmacokinet. 2021 Apr;60(4):471-484. doi: 10.1007/s40262-020-00942-7. Epub 2020 Nov 5.
Clinical trial NCT03715296: Lenalidomide Based Immunotherapy in the Treatment of DLBCL
Official title: Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: De novo DLBCL patients / Relapse Refractory DLBCL patients

Brief summary: This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients


Eligibility criteria: Inclusion Criteria:

Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)

Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.

No history of stem cell transplantation.

Written informed consent.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.

Clinically significant active infection.

Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.

Patients who are pregnant or breast-feeding.

HIV infection.

Primary outcomes:
measure: Complete response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression free survival rate
timeFrame: 1 year
measure: Overall survival rate
timeFrame: 1 year
measure: Overall response rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04297696: The Effects of Exercises on Gait in Hemophilic Individuals
Official title: Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilic Arthropathy
Keywords: hemophilia
exercise
gait kinematic
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. This situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. Disorders in these parameters are the main causes of gait dysfunction. The aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed as Hemophilia A or Hemophilia B
* To be over 18 years old
* To have hemophilic arthropathy in at least one joint
* Undergoing prophylaxis or factor VIII-IX replacement therapy

Exclusion Criteria:

* Having another congenital coagulopathy, such as Von Willebrand syndrome
* To be unable to walk due to hemophilic arthropathy
* Having another musculoskeletal problem
* Individuals with inhibitors against Factor VIII-IX

Primary outcomes:
measure: Haemophilia Joint Health Score
timeFrame: Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months
measure: Range of Motion Analysis with Kinovea Software
timeFrame: Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.
Secondary outcomes:
measure: Haemophilia Quality of Life Questionnaire for Adults
timeFrame: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months
measure: Six Minutes Walking Test
timeFrame: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Gym
Study officials:
affiliation: Gazi University
name: Nevin Atalay Güzel, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00691496: A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
Official title: A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
African-American
gay
bisexual
intervention trial
HIV Seronegativity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: New York Blood Center
name: The New York Academy of Medicine
First posted: 2008-06-05
Enrollment: 326
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk among African-American men who have sex with men (MSM).


Eligibility criteria: Inclusion Criteria: identify as African-American, Black, Caribbean Black or multiethnic Black, report sex with men

Exclusion Criteria:

* Participated in pilot
* Identify as transgender
* Plan to move before end of study
* Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline
* Under 18 years of age

Primary outcomes:
measure: The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM.
timeFrame: 3 months after completing intervention
Secondary outcomes:
measure: Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.
timeFrame: 3 months after completing the intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Blood Center
state: New York
Study officials:
affiliation: New York Blood Center
name: Beryl Koblin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koblin BA, Bonner S, Powell B, Metralexis P, Egan JE, Patterson J, Xu G, Hoover DR, Goodman K, Chin J, Tieu HV, Spikes P. A randomized trial of a behavioral intervention for black MSM: the DiSH study. AIDS. 2012 Feb 20;26(4):483-8. doi: 10.1097/QAD.0b013e32834f9833.
citation: Tieu HV, Spikes P, Patterson J, Bonner S, Egan JE, Goodman K, Stewart K, Frye V, Xu G, Hoover DR, Koblin BA. Sociodemographic and risk behavior characteristics associated with unprotected sex with women among black men who have sex with men and women in New York City. AIDS Care. 2012;24(9):1111-9. doi: 10.1080/09540121.2012.672723. Epub 2012 Apr 25.
citation: Tieu HV, Xu G, Bonner S, Spikes P, Egan JE, Goodman K, Stewart K, Koblin BA. Sexual partner characteristics, serodiscordant/serostatus unknown unprotected anal intercourse and disclosure among human immunodeficiency virus-infected and uninfected black men who have sex with men in New York City. Sex Transm Dis. 2011 Jun;38(6):548-54. doi: 10.1097/OLQ.0b013e318203e2d7.
Clinical trial NCT04385758: Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes
Official title: Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Keywords: Community paramedicine
Diabetes mellitus
Diabetes distress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.


Eligibility criteria: Inclusion Criteria (Patients):

* Most recent hemoglobin A1c ≥ 9% within the last 2 years.
* Age ≥ 18 years old.
* Type 1 or type 2 diabetes.
* Paneled to a Mayo Clinic or Mayo Clinic Health System practice.
* Able to provide informed consent.
* Proficient in English.
* Community-dwelling.
* Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn counties).

Inclusion Criteria (Paramedics):

•Community Paramedics who delivered the Diabetes-REM intervention.

Exclusion Criteria:

* Cognitive impairment precluding informed consent.
* Lack of conversational English skills.
* Resident of a long-term care facility.
* Enrolled in hospice.
* Enrolled in a care coordination or disease management program.
* Advanced or terminal illness.

Primary outcomes:
measure: Diabetes Distress (using DDS)
timeFrame: 1 month
Secondary outcomes:
measure: Diabetes Distress (using DDS)
timeFrame: 4 months
measure: Confidence in Diabetes Self-Management (using DSMQ)
timeFrame: 1 and 4 months
measure: Health-Related Quality of Life (using EQ-5D)
timeFrame: 1 and 4 months
measure: Self-Reported Hypoglycemia and Hyperglycemia
timeFrame: 1 and 4 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rozalina McCoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juntunen MB, Liedl CP, Carlson PN, Myers LA, Stickler ZR, Ryan Schultz JA, Meilander AK, Behnken E, Lampman MA, Rogerson MC, Fischer KM, McCoy RG. Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care. BMJ Open. 2022 Apr 21;12(4):e057224. doi: 10.1136/bmjopen-2021-057224.
Clinical trial NCT01849458: BioFiber Scaffold Post-Market Observational Study
Official title: BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Thickness Rotator Cuff Tear
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2013-05-08
Enrollment: 50
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: Orthopedic referral clinic

Brief summary: The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

Detailed description: Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older

  * Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
  * Patients willing and able to comply with the requirements of the study protocol and provide informed consent.

Exclusion Criteria:

* Patients with active or latent infection
* Patients with decreased vascularity
* Patients with pathological soft tissue conditions
* Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
* Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
* Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager

Primary outcomes:
measure: Number of Participants With Device Associated Adverse Events
timeFrame: 12 Months
Secondary outcomes:
measure: Clinical Functional Outcome - Adjusted Constant-Murley Score
timeFrame: 6 Months
measure: Clinical Functional Outcome - Adjusted Constant-Murley Score
timeFrame: 12 Month
measure: Clinical Functional Outcome - WORC Index
timeFrame: 6 Months
measure: Clinical Functional Outcome - WORC Index
timeFrame: 12 Months
measure: Number of Study Participants With Re-tears
timeFrame: 6 Months
measure: Number of Study Participants With Re-tears
timeFrame: 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Insall Scott Kelly Institute
state: New York
city: Charlottesville
country: United States
facility: University of Virginia Sports Medicine and Shoulder Surgery
state: Virginia
city: St. Gregoire
country: France
facility: St. Gregoire
Study officials:
affiliation: University of Virginia
name: Stephen Brockmeier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Insall Scott Kelly Institute
name: Timothy Reish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Gregoire, France
name: Philippe Collin, MD
role: PRINCIPAL_INVESTIGATOR
References: