louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03630965: CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
Official title: Audiovisual Tool Use in the ICU, to Impact the Anxiety Level of Patients' Surrogates While Deciding on Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.

Detailed description: Designated surrogate decision makers of 30 medical intensive care unit patients will be consented and enrolled to receive either a video describing CPR and it's outcomes after standard of care code discussions versus standard of care code discussions alone. All participants will complete a short questionnaire to determine their knowledge level regarding CPR and to assess their anxiety levels. Patients who view the video will also rate their comfort level while watching the video on a 5 point Likert scale.

Eligibility criteria: Surrogate decision maker or power of attorney identified within the first 48 hours of ICU admission.

Surrogates or power of attorney over the age of 18 y/o

Secondary Subjects:

* Admitted to the ICU
* Critically ill to the point of treating team discussing code status with LAR/POA/Family

Primary outcomes:
measure: Measure the impact of CPR video on the Surrogate's level of anxiety during the decision-making process on code status, in the ICU compared to the control group of surrogates (No intervention group).
timeFrame: 2.5 years
Secondary outcomes:
measure: Measure the impact of CPR video on patients' surrogate's knowledge about CPR, when compared to the No intervention group.
timeFrame: 3 years
measure: Analyze the surrogates' comfort when watching the video.
timeFrame: 3 years
measure: Describe if the CPR video's impact on surrogates' anxiety level, is affected by the patient's severity of illness as per the SOFA score.
timeFrame: 3 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Tirsa Ferrer Marrero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrer Marrero TM, Barash M, Jaber B, Nothem M, Shah K, Weber MW, Zellner Jones S, Kennedy P, Graf J, Broaddrick S, Garacci Z, Banerjee A, Kryworuchko J, Patel J. The impact of a cardiopulmonary resuscitation video on reducing surrogates' anxiety: A pilot randomized controlled trial. J Crit Care. 2021 Apr;62:235-242. doi: 10.1016/j.jcrc.2020.11.001. Epub 2020 Dec 3.
Clinical trial NCT00124865: Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study
Official title: Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Diarrhea
Keywords: Campylobacter
Bacterial enteritis
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2005-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.

Detailed description: This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart:

Group / N\* / rFla-MBP

A / 8/ 25 micrograms

B / 8/ 125 micrograms

C / 8/ 625 micrograms

D / 8/ 1000 micrograms

\* minimum of 6 volunteers per group

An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+/- 1 day), the third is day 28 (+/- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.

Eligibility criteria: Inclusion Criteria:

* Healthy adult
* 70% accuracy on comprehension test
* Availability for required visits and telephone follow up

Exclusion Criteria:

* Pregnancy or breastfeeding
* Chronic health problems
* Abnormalities found on physical examination
* Use of immunosuppressive drugs, such as corticosteroids or chemotherapy
* Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV)
* Abnormalities found on basic laboratory screening
* Prior exposure to Campylobacter
* Current smoker
* Chronic sinusitis or seasonal rhinitis

Primary outcomes:
measure: Local and systemic reactions
measure: Mucosal immunogenicity
measure: Systemic immunogenicity
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
affiliation: Naval Medical Research Center
name: David Tribble, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488865: RexMedical- Option* Vena Cava Filter IDE Study
Official title: RexMedical- Option* Vena Cava Filter IDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: increased risk for PE require caval interruption
Lead sponsor: Rex Medical
Sponsor class: INDUSTRY
First posted: 2007-06-20
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: PREVENTION

Brief summary: This study is designed to evaluate the safety and efficacy of the RexMedical Option\* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.


Eligibility criteria: Key Inclusion Criteria:

* Patient is at least 18 years of age
* Patient requires temporary or permanent caval interruption

Key Exclusion Criteria:

* Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant
* Patient is currently enrolled in another investigational device or drug trial

Primary outcomes:
measure: Percentage of Participants With Clinical Success
timeFrame: up to 180 days
measure: Percentage of Participants With Retrieval Clinical Success
timeFrame: upto 175 days
Secondary outcomes:
measure: Placement Technical Success
timeFrame: Immediately post placement procedure
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Peninsula Surgical Specialists Medical Group, Inc.
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: Miami Cardiac & Vascular Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia
state: New York
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
citation: Johnson MS, Nemcek AA Jr, Benenati JF, Baumann DS, Dolmatch BL, Kaufman JA, Garcia MJ, Stecker MS, Venbrux AC, Haskal ZJ, Avelar RL. The safety and effectiveness of the retrievable option inferior vena cava filter: a United States prospective multicenter clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1173-84. doi: 10.1016/j.jvir.2010.04.004. Epub 2010 Jul 3.
Clinical trial NCT06988865: Benign Migratory Glossitis Associated With Antiangiogenic Drugs
Official title: Benign Migratory Glossitis Associated With Antiangiogenic Drugs Used in Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Geographic Tongue
Keywords: antiangiogenic drugs
glossitis benign migratory
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 8
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: Hospital -Instituto do Cancer do Estado de Sao Paulo-ICESP

Brief summary: Oral clinical descriptions related to adverse events in patients treated with those elective multi-targeted receptor tyrosine kinase inhibitors and a recombinant humanised monoclonal antibody

Detailed description: Electronical medical and dental records, high-resolution digital photograph were reviewed. Demographic data, medical background, clinical and laboratory information were recorded for each individual case.

Eligibility criteria: Inclusion Criteria:

* patient's charts which underwent antiangiogenic targeted drugs

Exclusion Criteria:

* chemoterapy without angiogenesis inhibitors

Primary outcomes:
measure: Benign migratory glossitis
timeFrame: From enrollment to the end of study at 7 years
Secondary outcomes:
measure: Adverse events
timeFrame: From enrollment to the end of study at 7 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Mauricio Neves Gomes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Cancer do Estado de São Paulo
name: Wagner Gomes da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837365: Impact of Neuropsychological Disorders in Multiple Sclerosis
Official title: Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study involves MS patients with and without neuropsychological disorders.

The patient will benefit from:

* A routine neuropsychological assessment, including a cognitive and emotional assessment
* A clinical examination
* A three-dimensional analysis of movement


Eligibility criteria: Inclusion Criteria:

* Understanding and able to speak French
* Carriers of MS with relapsing remitting form (RRMS-RR) with an EDSS \<4
* No significant motor, cerebellar or somesthesia disorders of the upper limbs or visual disturbances (side to a visual EDSS \<2)
* Absence of corticosteroid intake in the last four weeks
* Benefiting from health insurance coverage
* Not showing any flare-ups or worsening of the disease in the last 6 weeks
* No botulinum toxin injection for more than 4 months

Exclusion Criteria:

* People with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders preventing verbal communication or reading,
* Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
* Refusal to participate after clear and fair information about the study.
* Adults under tutorship, curatorship or safeguard of justice
* With orthopedic treatment influencing walking
* Pregnant woman

Primary outcomes:
measure: Cadence of walking (in cycles.min-1)
timeFrame: 60 days
measure: Step length (in m)
timeFrame: 60 days
measure: Walking speed (in m.s-1)
timeFrame: 60 days
measure: Range of motion in the lower limbs in degrees
timeFrame: 60 days
Secondary outcomes:
measure: Ocular fixation time (measured in ms)
timeFrame: 60 days
measure: Muscle contractions determined by the electromyogram (EMG) (mV)
timeFrame: 60 days
measure: Displacements (in mm) during walking
timeFrame: 60 days
measure: Acceleration (in mm.s-2) during walking
timeFrame: 60 days
measure: Joint angles
timeFrame: 60 days
Other outcomes:
Locations:
city: Lille
country: France
facility: St Vincent hospital - neurological service
city: Lomme
country: France
facility: St Philibert hospital - Neurologial service
city: Lomme
country: France
facility: St Philibert hospital - Physical Medicine and Rehabilitation
Study officials:
affiliation: GHICL
name: Caroline Massot, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00919165: Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement
Official title: Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Function in Carotid Stenting
Keywords: carotid stenting
cognitive function
pre and post stent
severe carotid artery stenosis
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2009-06-12
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe carotid artery stenosis

Brief summary: To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

Detailed description: Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

Eligibility criteria: Inclusion Criteria:

* 40-80 years of age
* Right hand dominate
* Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
* Baseline doppler study with a peak systolic velocity of 400cm/sec
* Patient is deemed candidate for carotid artery stenting
* TIMI flow of 1,2 or 3
* 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
* Subjects are able to give informed consent
* Subjects are willing/able to complete follow-up visits

Exclusion Criteria:

* History of major stroke: within the past 6 months
* History of Alzheimers disease or Dementia
* Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
* Planned intervention opposite carotid artery within 2 months
* Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
* Any individual identified with cognitive impairment which would affect their performance during cognitive testing.

Primary outcomes:
measure: to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis
timeFrame: 45 days
Secondary outcomes:
measure: to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting
timeFrame: 45 days
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Steven Pastyrnak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01189565: Continuous Postoperative Pulse Oximetry in Patients Presenting for Total Hip and Total Knee Replacement
Official title: Continuous Postoperative Pulse Oximetry in Patients Presenting for Total Hip and Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Keywords: Total Hip Replacement/Revision
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Joint Replacement

Brief summary: The purpose of this study is to evaluate the incidence of low levels of oxygen as determined by standard pulse oximetry monitor in patients who have had total hip or knee replacement/revision.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing knee replacement or hip replacement/revision

Exclusion Criteria:

* Patients requiring mechanical ventilation after surgery
* Patients with hemoglobinopathy that cause inaccurate pulse oximetry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Matthew D McEvoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011.
citation: McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
citation: Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761.
Clinical trial NCT03313765: MI-based PrEP Intervention
Official title: A Brief Motivational Interviewing-based Intervention to Improve HIV Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PrEP Uptake
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 86
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: Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy in preventing HIV infection among MSM. However, uptake in clinical settings has been slow for several reasons, including low awareness and education, low perceived HIV risk, concern for side-effects, and stigma associated with taking the medication. The purpose of the proposed study is to develop and evaluate a brief motivational interviewing (MI) intervention to promote PrEP uptake among MSM during the course of routine HIV screening at a public sexually transmitted disease (STD) clinic.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Assigned male at birth and currently identify as male
3. Score at least 10 on the HIV Incident Risk Index for MSM
4. HIV-negative based on results of antibody test
5. English- or Spanish-speaking
6. Have access to a working phone
7. Have not taken PrEP

Exclusion Criteria:

1. Have previously taken PrEP
2. Symptoms of acute HIV infection at baseline
3. HIV positive
4. A clinical contraindication to PrEP (e.g., renal dysfunction)
5. Non-English or non-Spanish speaking

Primary outcomes:
measure: PrEP uptake
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University/The Miriam Hospital
name: Philip A Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944865: Interval Training and Performance in Mountain Bikers
Official title: Effect of Intermittent Versus Interval Training on Mountain Bike Cross-country Performance: a Parallel-group Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Aerobic Interval Training
Supramaximal Training
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aerobic fitness is important for mountain bikers, but riders should also be able to generate maximal and supramaximal efforts in some crucial phases of the competition. Although there is an increase interest in high-intensity aerobic training, to investigators knowledge, there are no studies examining the effects of interval (INTV) or intermittent training (INTM) in mountain bikers. The aim of this study was to compare the effects of INTV and INTM on aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset of blood lactate accumulation) but more importantly on performance as measured using a controlled mountain bike race, i.e. simulation. The investigators hypothesized that INTV and INTM training were equally effective in improving Wmax, Lactate threshold and onset of blood lactate accumulation, but INTV was superior in enhancing performance in mountai bike race simulation.This hypothesis is due to studies that have shown higher gains in performance with long duration of aerobic high intensity interval training in comparison to the shorter training at a higher intensity.

Detailed description: The study is a controlled and randomized trial.

Eligibility criteria: Inclusion Criteria:

* Specific training in the mountain bike sport

Exclusion Criteria:

* Use of pharmacological substances

Primary outcomes:
measure: Interval Training and Performance in Mountain Bikers
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Gama Filho University
Study officials:
affiliation: Gama Filho University
name: Tony M Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inoue A, Impellizzeri FM, Pires FO, Pompeu FA, Deslandes AC, Santos TM. Effects of Sprint versus High-Intensity Aerobic Interval Training on Cross-Country Mountain Biking Performance: A Randomized Controlled Trial. PLoS One. 2016 Jan 20;11(1):e0145298. doi: 10.1371/journal.pone.0145298. eCollection 2016.