louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05856123: A Study to Evaluate SimPull for Lateral Patient Transfer
Official title: Single-site, Pilot Study Evaluating SimPull As a Primary Means of Lateral Patient Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Patient Transfer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: The Patient Company, LLC
First posted: 2023-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to test an investigational device called SimPull to see if it is a more efficient method of transferring a patient from one bed to another compared to that of current methods. The purpose of this research is to gather information on the safety and effectiveness of the SimPull device.


Eligibility criteria: Inclusion Criteria:

* Patients requiring lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
* Patients requiring lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
* Patient does not have compound fractures or cervical fractures present.
* Patient does not have skin damage or open wounds to the dorsal cavity.
* Patient or legally authorized representative (LAR) must be able/present to sign consent.

Exclusion Criteria:

* Patients who do not require lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
* Patients who do not require lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
* Patient has compound fractures or cervical fractures present.
* Patient has skin damage or open wounds to the dorsal cavity.
* Patient or legally authorized representative (LAR) are unable/present to sign consent.

Primary outcomes:
measure: Time to complete lateral transfer
timeFrame: Baseline
measure: Force needed for transfer
timeFrame: Baseline
Secondary outcomes:
measure: Clinician Satisfaction
timeFrame: Baseline
measure: Clinician perception of injury risk
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Deanna Covelli, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950323: Intra-parotid Facial Nerve Tractography
Official title: Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parotid Tumor
Keywords: Parotidetomy
Tractography
Facial nerve
Facial palsy
Tumor of parotid gland
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.

Detailed description: Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.

MRI tractography is a new imaging technique that can characterize nerve fibers and their path.

The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.

Eligibility criteria: inclusion criteria :

* Major patient
* Patient with initial parotid mass or recurrent
* Parotidian mass with surgical indication
* Benign or malignant
* With or without preoperative facial paralysis
* Patients consenting the protocol

exclusion criteria :

* Parotidian masses without surgical indication
* Patient with a classic contraindication to MRI

Primary outcomes:
measure: Facial nerve's path
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03816423: Use of Videos to Improve Patient Knowledge on Prenatal Genetics
Official title: The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneuploidy
Birth Defect
Keywords: patient education
genetic counseling
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Tampa General Hospital
First posted: 2019-01-25
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit.

Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled "How to decide about prenatal genetic testing".
Primary purpose: OTHER

Brief summary: This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options.

Detailed description: During pregnancy, women are routinely counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing options to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. A standardized educational video on prenatal screening may enhance a patient's understanding and knowledge of testing and support more informed decisions.

The objective of this study is to evaluate and compare patient knowledge scores on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

Eligibility criteria: Inclusion Criteria:

* pregnancy, english or spanish-speaking

Exclusion Criteria:

* minors \<18 years old,
* \> 21 completed weeks of gestational age,
* prior genetic counseling during current pregnancy
* fetus with known ultrasound abnormality

Primary outcomes:
measure: Knowledge score
timeFrame: same day for both groups
measure: Knowledge score change
timeFrame: same day for both groups
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Genesis Healthpark- TGH
state: Florida
Study officials:
affiliation: University of South Florida
name: Karla Leavitt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384823: A Study of EDP-938 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-938 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-938 Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: First-in-Human
Single Ascending Dose
Multiple Ascending Dose
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2017-12-27
Enrollment: 90
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: This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects

Detailed description: The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.

Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
timeFrame: Up to 8 days
Secondary outcomes:
measure: Cmax of EDP-938
timeFrame: Up to 5 Days
measure: Cmax of EDP-938
timeFrame: Up to 11 Days
measure: AUC of EDP-938
timeFrame: Up to 5 Days
measure: AUC of EDP-938
timeFrame: Up to 11 Days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01628523: Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
Official title: Mechanical Ventilation in the Emergency Department: A Prospective Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Mechanical Ventilation
Acute Lung Injury
Keywords: Respiratory failure
Mechanical ventilation
Acute lung injury
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Christiana Care Health Services
name: University of Cincinnati
First posted: 2012-06-26
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department requiring invasive mechanical ventilation.

Brief summary: Despite its life-saving potential, the mechanical ventilator has great potential to do harm. Despite years of research, the mortality in acute lung injury (ALI) remains very high. Treatment options after ALI onset are very limited, therefore prevention may be the best option. Unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ALI is unknown. The investigators hypothesize that mechanical ventilation is frequently used in the ED and for a variety of reasons, and that ED mechanical ventilation has an effect on long term outcomes.


Eligibility criteria: Inclusion Criteria:

* Ventilation either via an endotracheal tube or tracheostomy

Exclusion Criteria:

* Non-invasive positive pressure ventilation;
* Death in the immediate post-intubation phase of care;
* Chronic ventilator-dependence, either at home or extended care facility.

Primary outcomes:
measure: To Further Characterize ED Mechanical Ventilation
timeFrame: 1 month
Secondary outcomes:
measure: The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS
timeFrame: 1 month
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Iowa City
country: United States
facility: University of Iowa College of Medicine
state: Iowa
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Brian M Fuller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuller BM, Mohr NM, Miller CN, Deitchman AR, Levine BJ, Castagno N, Hassebroek EC, Dhedhi A, Scott-Wittenborn N, Grace E, Lehew C, Kollef MH. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study. Chest. 2015 Aug;148(2):365-374. doi: 10.1378/chest.14-2476.
Clinical trial NCT05542823: Effect of Cuff Pressure of Endotracheal Tube on POST
Official title: Effect of Cuff Pressure of Endotracheal Tube on Postoperative Sore Throat: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laparoscopic Surgery
Tracheal Intubation Morbidity
Sore-throat
Keywords: Laparoscopic surgery
Endotracheal intubation
Cuff pressure
Sore throat
Hoarseness
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 337
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

Brief summary: The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.

Detailed description: For patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. The incidence of postoperative sore throat was evaluated via direct questioning in all patients. This study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

Exclusion Criteria:

* Patients who already had sore throat and hoarseness before surgery
* Patients who were expected to have anticipated difficult airway
* Surgery duration \< 1 hour

Primary outcomes:
measure: Incidence of postoperative sore throat at 24h postoperatively.
timeFrame: at 24h postoperatively.
Secondary outcomes:
measure: Incidence of postoperative sore throat at 1h postoperatively.
timeFrame: at 1h postoperatively
measure: Incidence of postoperative sore throat at 48h postoperatively.
timeFrame: at 48h postoperatively
measure: Incidence of postoperative hoarseness at 1h postoperatively.
timeFrame: at 1h postoperatively
measure: Incidence of postoperative hoarseness at 24h postoperatively.
timeFrame: at 24h postoperatively.
measure: Incidence of postoperative hoarseness at 48h postoperatively.
timeFrame: at 48h postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
state: Please Select An Option
city: Seoul
country: Korea, Republic of
facility: Hyun-Kyu Yoon
Study officials:
affiliation: Seoul National University
name: Hyun-Kyu Yoon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04710823: Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.
Official title: Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serratus Anterior Plane Block
Thoracic Paravertebral Block
Ultrasound
Multiple Traumatic Rib Fractures
Analgesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.


Eligibility criteria: Inclusion Criteria:

* Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).

Exclusion Criteria:

* • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.

  * Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.
  * Patients had indications for mechanical ventilation on admission or during the study period.
  * Patients had indications for immediate surgery for other associated injuries.
  * Patients with hemodynamic instability.
  * Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.

Primary outcomes:
measure: Degree of pain scores
timeFrame: Four days after the block
Secondary outcomes:
measure: Total consumption of morphine
timeFrame: Four days after the block
measure: Changes of forced vital capacity (FVC)
timeFrame: Four days after the block
measure: Changes of forced expiratory volume in one second (FEV1)
timeFrame: Four days after the block
measure: Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
timeFrame: Four days after the block
measure: Length of ICU stay
timeFrame: Four days after the block
measure: Length of hospital stay
timeFrame: Four days after the block
measure: Incidence of complications
timeFrame: Four days after the block
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT00697723: Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery bypass graft
Intra-aortic balloon pump
transit-time flowmetry
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the different performance of arterial and venous graft with intra-aortic balloon pump support following coronary artery bypass.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing coronary artery bypass surgery

Exclusion Criteria:

* Aortic insufficiency;
* Diffuse atherosclerosis impeding intra-aortic balloon pump introduction

Primary outcomes:
measure: Hospital mortality and morbidity
timeFrame: three years
Secondary outcomes:
measure: Transit-time flowmetry
timeFrame: three years
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University of Magna Graecia - Cardiac Surgery unit
Study officials:
References:
citation: Baskett RJ, Ghali WA, Maitland A, Hirsch GM. The intraaortic balloon pump in cardiac surgery. Ann Thorac Surg. 2002 Oct;74(4):1276-87. doi: 10.1016/s0003-4975(02)03663-9.
citation: Christenson JT, Simonet F, Badel P, Schmuziger M. Evaluation of preoperative intra-aortic balloon pump support in high risk coronary patients. Eur J Cardiothorac Surg. 1997 Jun;11(6):1097-103; discussion 1104. doi: 10.1016/s1010-7940(97)00087-0.
citation: Tedoriya T, Kawasuji M, Sakakibara N, Takemura H, Watanabe Y, Hetzer R. Coronary bypass flow during use of intraaortic balloon pumping and left ventricular assist device. Ann Thorac Surg. 1998 Aug;66(2):477-81. doi: 10.1016/s0003-4975(98)00468-8.
citation: Yoshitani H, Akasaka T, Kaji S, Kawamoto T, Kume T, Neishi Y, Koyama Y, Yoshida K. Effects of intra-aortic balloon counterpulsation on coronary pressure in patients with stenotic coronary arteries. Am Heart J. 2007 Oct;154(4):725-31. doi: 10.1016/j.ahj.2007.05.019.
Clinical trial NCT03833323: Implantable System for Remodulin Post-Approval Study
Official title: Implantable System for Remodulin Post-Approval Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Remodulin
treprostinil
DelIVery for PAH
Implantable Pump
Drug Pump
Intrathecal Catheter
Targeted Drug Delivery
Programmable Pump
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: United Therapeutics
First posted: 2019-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly implanted patients that are intended to receive an ISR.

Brief summary: The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

Detailed description: The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Eligibility criteria: Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
* Subject is intended to receive an eligible ISR product.
* Subject is at least 22 years of age.

Exclusion Criteria:

* Subject is pregnant.
* Subject who is expected to be inaccessible for follow-up.
* Subject with exclusion criteria required by local law.
* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).

Primary outcomes:
measure: Catheter-related complications
timeFrame: Implant to 5 years post-implant
measure: Pump failures
timeFrame: Implant to 5 years post-implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Robert Bourge, MD
role: STUDY_CHAIR
References: