louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02785575: Adjusted Calculation of Heparin and Protamin Dosing and Correlation With Postoperative Bleeding and Transfusions
Official title: The Impact of an Adjusted Calculation Model Regarding Heparin and Protamine Dosing on Bleeding and Transfusions After Cardiac Surgery Compared With Standard Dosing: A Randomized Single Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Surgery
Bleeding
Transfusion
Protamine Sulfate
Heparin
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-05-30
Enrollment: 200
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 study will compare a novel calculation model (HeProCalc AB) with a standard weight-based and activated clotting time adjusted calculation for the dosing of Heparin and protamine and assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.

Detailed description: During cardiac surgery with cardiopulmonary bypass (CPB), efficient anticoagulation is required in order to avoid microscopic clot formation or, in worst case, massive lift threatening thrombus formation. Heparin is by far the most common drug used to prevent blood from coagulating during CPB. Activated clotting time (ACT) is a point-of-care test of fibrin clotting time that has to be well prolonged to initiate safe CPB.

Following weaning from CPB, heparin is reversed by protamine. Administration of excess doses of protamine may have a deleterious effect on coagulation and contribute to postoperative bleeding with need of blood transfusions. In connection with CPB management, heparin and protamin doses are commonly calculated using body weight and ACT. However, a new Heparin-Protamin-Calculation computer program (HeProCalc) has been developed to provide patient titrated dosing of both heparin and protamin. However, any benefits regarding postoperative bleeding and transfusions has not been thoroughly investigated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery with the use of cardiopulmonary bypass
* Indication and planned use of heparin and protamine

Exclusion Criteria:

* Inability to leave informed consent or understanding the outline of the study
* Known coagulation disorder

Primary outcomes:
measure: Postoperative bleeding
timeFrame: 12 hours after chest closure
Secondary outcomes:
measure: Postoperative transfusions
timeFrame: 12 hours after chest closure
measure: Bleeding according to other validated definitions
timeFrame: 12 hours after chest closure
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: Kjellberg G, Sartipy U, van der Linden J, Nissborg E, Lindvall G. An Adjusted Calculation Model Allows for Reduced Protamine Doses without Increasing Blood Loss in Cardiac Surgery. Thorac Cardiovasc Surg. 2016 Sep;64(6):487-93. doi: 10.1055/s-0035-1558649. Epub 2015 Aug 13.
Clinical trial NCT03583775: 3D Cine Cardiovascular Magnetic Resonance
Official title: Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with different races and ethnicity are included in the study.

Brief summary: Conventional CMR is based on breath-hold 2D cine image acquisitions which are sequentially acquired in different imaging planes. The necessity of precisely planning and then acquiring multiple 2D imaging planes during breath-hold is relatively inefficient and leads to CMR exam times of ≤60 minutes. However, some patients are too ill or young to hold their breath. Furthermore, 2D images sometimes fail to provide a complete picture of complex 3D anatomy of patients with complex morphology.

To address these limitations, we have recently developed a 3D cine (3 spatial dimensions plus time) CMR technique. Rather than acquiring 2D cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3D block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. This added efficiency should lead to a reduction in CMR exam time, increasing patient comfort, and making CMR exam easy and available for all. In addition, the 3D nature of the data may yield more complete information about the anatomy and physiology.

In this proposal, we will examine the agreement between the 2D cine and 3D cine CMR techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. The internal consistency of the measurements between the 2 techniques will be also investigated. This study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing CMR exams.


Eligibility criteria: Inclusion Criteria:

* Patients who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent. Informed consent/assent will be obtained.

Exclusion Criteria:

* Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.

Primary outcomes:
measure: End-diastolic and end-systolic volumes of right and left ventricles
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Dr. Tarek Alsaied
state: Ohio
Study officials:
References:
Clinical trial NCT01800175: Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in order to assess retention and replacement of the OTX Punctum Plug for this duration. At the Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum Plug is removed.


Eligibility criteria: Inclusion Criteria:

* Subject must be greater than or equal to 40 years of age.
* Subject is in general good health with overall healthy eyes.
* Subject has been informed of the nature of the study and is able to comply with study requirements, the visit schedule and has provided written informed consent, approved by the appropriate IRB.

Exclusion Criteria:

* Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
* History of ocular trauma within the past 6 months in either eye.
* History of ocular infection (bacterial, viral, or fungal) or ocular inflammation within 3 months prior to the study in either eye.
* History of chronic or recurrent inflammatory eye disease (i.e., iritis, scleritis, uveitis, herpes keratitis) in either eye.
* History of clinically relevant or progressive retinal diseases such as retinal detachment, retinal degeneration, or diabetic retinopathy in either eye.
* History of any other severe ocular pathology (including severe dry eye) in either eye.
* History of any laser or incisional surgery within 6 weeks prior to the study or scheduled ocular surgery during the study.

Primary outcomes:
measure: Punctum Plug retention for 90 days post insertion
timeFrame: 360 days
Secondary outcomes:
measure: Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270
timeFrame: 270 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02034175: Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Official title: Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Central Sleep Apnea
Mixed Sleep Apnea
Cheyne-Stokes Respiration
Keywords: apnea
hypopnea
polysomnography
respiratory
cheyne
Lead sponsor: Somnarus Inc
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).

Detailed description: This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.

The study includes the following steps:

Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.

Initial visit, includes:

1. Consent discussion and signature
2. History, vital signs, and physical exam

Night study

a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.

Additional visits If side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign the informed consent
* Able to comply with visits and follow ups included in this protocol
* Ages 20-85 years

Exclusion Criteria:

* An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
* Skin rash on the nose or on the maxillary area.
* A history of skin allergy to medical tape, and hypoallergenic tapes.
* A history of skin cancer on the nose or on the maxillary area.
* A history of the base of skull fractures, facial fractures

Primary outcomes:
measure: Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc
state: Arkansas
city: Burlingame
country: United States
facility: Peninsula Sleep Center
state: California
city: Tampa
country: United States
facility: The Good Sheperd Sleep Center, LLC
state: Florida
Study officials:
affiliation: Peninsula Sleep Center
name: Merhan Farid-Moayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687475: Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
Official title: Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lung Transplant; Complications
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Detailed description: The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Cystic Fibrosis
* To be listed for lung transplant
* Has purchased home spirometer

Exclusion Criteria:

* Diagnosis other than Cystic Fibrosis
* Unable to read
* Unable to use computer or smartphone device to access mobile application

Primary outcomes:
measure: Lung Allocation Score (LAS)
timeFrame: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).
Secondary outcomes:
measure: Time to transplant
timeFrame: Through study completion, up to 1 year
measure: Survival to transplant
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00141375: To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
Official title: An Open-Label Extension to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 132
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: To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Must have met the inclusion criteria of the preceding double-blind BID study in central pain following spinal cord injury.
* Must have received study medication under double-blind conditions.

Exclusion Criteria:

* Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.

Primary outcomes:
measure: Safety and Efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: Little Bay
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St. Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Warrawong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Shenton Park
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: NSW
country: Australia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04839575: Study of Latiglutenase in T1D/CD Patients
Official title: Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac
Lead sponsor: Entero Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Immunogenics, LLC
First posted: 2021-04-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two-period crossover design will be used where the treatment sequences will be assigned at random.
Primary purpose: TREATMENT

Brief summary: This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

Detailed description: This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

Eligibility criteria: Inclusion Criteria (select):

* Confirmed CD diagnosis
* Confirmed T1D diagnosis
* Seropositive
* Gluten free diet (12 months minimum)
* Experienced at least one self-reported moderate or greater severity symptom during the last 28 day period
* Willing to take study treatment daily
* Must sign informed consent

Exclusion Criteria (select):

* Wheat allergy
* History of peptic ulcer disease, esophagitis, IBS, IBD
* Active colitis
* Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
* Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
* Known refractory celiac disease (RCD1 or RCD2)
* Inability to give informed consent

Primary outcomes:
measure: Symptom Severity Reduction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: David Maahs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01427075: Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty
Official title: Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Magnetic Resonance Imaging
Sleep Apnea, Obstructive
Pharyngeal Muscles
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* diagnosis of obstructive sleep apnea syndrome

Exclusion Criteria:

* MRI contraindications

Primary outcomes:
measure: expansion of pharynx
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Do Servidor Publico Estadual
state: SP
Study officials:
affiliation: Hospital do Servidor Publico Estadual
name: CAROLINA AF VIEIRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950375: Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation
Official title: Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implantation
Keywords: Sensorineural Hearing Loss
Round Window
ear surgery
Cochlear implantation
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cochlear implantation

Brief summary: The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

Detailed description: Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.

CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.

Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.

Eligibility criteria: inclusion criteria :

* patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
* patients who agree to participate in the study
* patients who had preoperative temporal bone CT scan

exclusion criteria : patients who have :

* temporal bone malformation on temporal bone CT scan or MRI
* chronic otitis media (except simple middle ear effusion)
* middle ear surgery antecedent
* cochlear implant in the context of a reimplantation

Primary outcomes:
measure: peroperative round window exposure
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: