louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05368610: Lesion Contiguity in Very High Power-short Duration Ablation
Official title: Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Catheter ablation
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for PVI-only catheter ablation at Hospital Clinic, University of Barcelona

Brief summary: This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.


Eligibility criteria: Inclusion Criteria:

* paroxysmal or early persistent (max. 3 months) atrial fibrillation
* scheduled for PVI-only catheter ablation

Exclusion Criteria:

* long-standing persistent atrial fibrillation
* previous left atrial ablation
* claustrophobia preventing CMR
* sever renal insufficiency (GFR \>30 ml/min)
* gadolinium contrast allergy
* presence of implantable devices not compatible with magnetic resonance
* pregnancy and lactation

Primary outcomes:
measure: Ablation lesion contiguity as assessed by LGE-CMR
timeFrame: LGE-CMR at 3 months post-ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic, University of Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic, University of Barcelona
name: Till F. Althoff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202110: Early Propranolol After Traumatic Brain Injury: Phase II
Official title: A Phase II, Dose Escalation, Single Center Study on the Effects of Early Propranolol on Heart Rate, Blood Pressure, and Cerebral Perfusion Pressure in Subjects Who Present With Moderate to Severe Traumatic Brain Injury.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.


Eligibility criteria: Inclusion Criteria:

* patients who present within 6 hours of traumatic brain injury who have 1) a Glasgow Coma Scale (GCS) score of ≤8 or a GCS of 9-12 with computerized tomography brain scans demonstrating brain injury.

Exclusion Criteria:

* pregnancy,
* patients already treated with beta-blockers,
* patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment,
* myocardial infarction during the last 3 months,
* unstable or severe heart disease,
* severe chronic obstructive pulmonary disease,
* serious liver disease,
* cardiac ischemia that prevents the initiation of vasopressors,
* signs of cardiac arrhythmia or heart block on EKG,
* ischemic limb disease that prevents the initiation of vasopressors, vasopressors at maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.

Primary outcomes:
measure: Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT03536910: Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique
Official title: Evaluation of Copeptin Levels in Elective Cesarean Section With Spinal and General Anesthesia and Their Relationship With Fetal Stress: Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Distress
Keywords: copeptin levels
Cesarean section
general anesthesia
spinal anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

Detailed description: During the delivery process, the mother and the baby generate some endocrine responses to this emotional and physical stressful action. Arginin-Vasopressin prohormone (copeptin), which is more stable and measurable in blood, is used as an endogenous stress indicator. Copeptin levels have been shown to be significantly increased in vaginally delivery when compared to cesarean section (c / s). In a caesarean section; it is a known fact that when the general anesthetic method and the used anesthetic substances are taken into consideration, it gives a significant stress to the mother and the baby. Spinal anesthesia with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular blockers may reduce fetal distress. However, there was no study investigating the effect of the anesthesia techniques in elective cesarean section on the fetal stress and the level of copeptin, in the literature review. Therefore investigators aimed to compare spinal and general anesthesia technique in elective cesarean section, to evaluate level of copeptin and their relation with fetal distress.Investigators hope that this study will guide the anesthesia method that can be chosen primarily in caesarean section.

Eligibility criteria: Inclusion Criteria:

* 18-40 years of age
* ASA I-II
* 36-40 gestational weeks
* BMI ≤ 40
* Undergoing elective cesarean section

Exclusion Criteria:

* Coagulopathy
* Known central or peripheral nerve disease
* fetal anomalies
* birth weight less than 2000 grams and above 4500 grams,
* infants with a risk of meconium or amniotic fluid aspiration
* kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, Rh incompatibility, congenital malformations

Primary outcomes:
measure: Changes in copeptin levels after general or spinal anesthesia
timeFrame: Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University
name: Ece YAMAK ALTINPULLUK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288910: Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver
Official title: Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Metastatic Carcinoma to the Liver
Keywords: Liver Perfusion
DynaCT Perfusion
Radioembolization
Chemoembolization
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 7
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 diagnosed with non-diffuse hepatocellular carcinoma or metastatic liver disease

Brief summary: This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

Detailed description: This project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. Subjects will undergo a CT perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. During the radioembolization mapping or chemoembolization procedure, 2 DynaCT acquisitions on the interventional C-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using Siemens' PBV software to generate blood volume maps. The diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Eligibility criteria: Inclusion Criteria:

* HCC or metastatic liver disease
* Candidate for radioembolization or chemoembolization

Exclusion Criteria:

* Pregnant
* Iodine allergy

Primary outcomes:
measure: Diagnostic accuracy of PBV maps
timeFrame: 1 year
Secondary outcomes:
measure: Relationship between blood volume values and patient treatment response
timeFrame: 1,4,7,13,19 months
measure: PBV blood volume value accuracy
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Mark Supanich, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143310: A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years
Official title: A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Fontem Ventures BV
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 209
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety and tolerability of an EVP over two years.


Eligibility criteria: Inclusion Criteria:

* Subject who participated in the EVP G1 S2 study (S2)
* Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
* No clinically significant abnormalities during the S2 study

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy during the S2 study
* Subjects with relevant illness history
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking
* Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.

Primary outcomes:
measure: Blood Pressure
timeFrame: 24 months
measure: Electrocardiogram (ECG): PR Interval
timeFrame: 24 months
measure: Lung Function Tests
timeFrame: 24 months
measure: Clinical Laboratory Parameters
timeFrame: 24 months
Secondary outcomes:
measure: Nicotine Withdrawal Symptoms
timeFrame: 24 Months
measure: Biomarkers of Exposure to Nicotine
timeFrame: 24 months
measure: Biomarkers of Effect
timeFrame: 24 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
state: England
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research
state: Wales
Study officials:
affiliation: Covance Clinical Research Unit
name: Jim Bush, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009710: Measured Hypocretin Levels and Recovery After Hip Surgery
Official title: Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Hip
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.

Brief summary: A specific group of neurons in the brain produces hypocretin, a peptide which has been established as an important regulator of sleep and wakefulness. Activation of these neurons (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the hypnotic properties of several anesthetics, and play a role in the induction and emergence from anesthesia. In humans there is a considerable inter-individual variability in hypocretin levels. This study aims to investigate how hypocretin levels affect the anesthetic care and recovery of patients undergoing elective hip surgery.


Eligibility criteria: Inclusion Criteria:- Adult (18 years of age or older)

* Male or female
* Scheduled for elective total hip arthroplasty at the Stanford Orthopedic Clinic.
* Comprehend spoken and written English Exclusion Criteria:- ASA physical status \> III (patients with severe systemic disease)
* Diagnosed psychiatric disease (except mild depression)
* Any diagnoses CNS disease or dementia
* History of stroke
* History of untreated thyroid disease
* Difficulty in airway management (ventilation and/or intubation)
* Body Mass Index (BMI) \> 35 kg/m2

Primary outcomes:
measure: Anesthetic Recovery Times
timeFrame: 0-72 hours after surgery
Secondary outcomes:
measure: sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG
timeFrame: during anesthetic induction
measure: pain and sleepiness
timeFrame: from 0-72 hours after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anthony Doufas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03144310: To Evaluate the Role of Lung Ultrasonography for Detection of Atlelectasis in Robot Assisted Laproscopic Pelvic Sugeries
Official title: TO EVALUATE THE ROLE OF LUNG ULTRASONOGRAPHY FOR DETECTION OF ATELECTASIS IN ADULTS UNDERGOING ROBOT ASSISTED LAPAROSCOPIC PELVIC SURGERIES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: to Detect the Incidence of Atelectasis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-05-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA Iand II age 18-70 yrs

Brief summary: Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis

Detailed description: Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis inclusion criteria: age 18 to 70 yrs age ASA I and II robot assisted pelvic surgeries in steep trendelenburg position

exclusion criteria: cardiac disese severe obstructive and restrictive disease upper airways infection ASAIII and IV

Eligibility criteria: Inclusion Criteria:

* ASA Iand II age 18-70 yrs robot assisted pelvis surgeries

Exclusion Criteria:

* ASA II and IV cardiac and lung disease

Primary outcomes:
measure: incidence of atelectasis
timeFrame: 24hrs
Secondary outcomes:
measure: risk factor identification
timeFrame: 24hrs
Other outcomes:
Locations:
Study officials:
affiliation: pgimer
name: Pgimer
role: STUDY_CHAIR
References:
Clinical trial NCT06757010: A Study of NE3107 in Early Parkinson's
Official title: A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinsons Disease (PD)
Keywords: Treatment naïve Parkinson's
Early Parkinson's
Lead sponsor: BioVie Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are:

* Will bezisterim decrease movement symptoms of Parkinson's disease?
* What medical problems do participants have when taking bezisterim?

Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease.

Participants will

* have a physical examination that includes an electrocardiogram
* take drug or placebo twice daily for four months
* visit a clinical site or receive an at home visit seven times over the course of five months


Eligibility criteria: Inclusion Criteria:

* 45 years to 80 years of age
* diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
* nearing the need for symptomatic therapy
* agree to use birth control measures
* provide voluntary consent
* willing to allow blood collection for DNA methylation analysis
* pass all screening tests and procedures

Exclusion Criteria:

* has taken levodopa or another similar drug for the motor symptoms of PD
* a known or strongly suspected familial cause for PD diagnosis
* major mental health or physical illness
* medical history of major mental or physical illness

Primary outcomes:
measure: Change from baseline in the MDS-UPDRS Part III
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change from baseline in MDS-UPDRS Part I and II
timeFrame: 12 weeks
measure: Percent of subjects with improvement in Clinical Global Impression
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Morrisville
country: United States
facility: Science 37 (Nationwide Site)
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
Study officials:
References:
Clinical trial NCT04010110: Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics
Official title: Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydroxychloroquine Toxic Retinopathy
Keywords: Hydroxychloroquine
Toxic retinopathy
Hydroxychloroquine screening
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
Collaborators: name: King Khalid University Hospital
First posted: 2019-07-08
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the ophthalmology clinics at King Khalid University Hospital and The Eye Center in Riyadh, Saudi Arabia.

Brief summary: This study assesses the ocular toxicity in patients on high dose hydroxychloroquine (HCQ) as per the latest guidelines of the American Academy of Ophthalmology (AAO).

Detailed description: Hydroxychloroquine (HCQ) is an anti-malarial drug that is used to treat a variety of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, juvenile idiopathic arthritis and Sjogren's syndrome. Hydroxychloroquine is a less toxic metabolite of chloroquine. There is an ongoing increase in the number of patients who are using HCQ for prolonged duration because of the expanding indications and the relatively safe systemic profile.

Hydroxychloroquine can cause variable ocular adverse effects including corneal deposits, posterior sub-capsular cataract, ciliary body dysfunction and toxic retinopathy. Toxic retinopathy caused by HCQ has been recognized for many years. Patients with toxic retinopathy usually complain of blurry vision. The classical clinical picture of HCQ toxic retinopathy is a bilateral bull's-eye maculopathy, which is caused by a ring of parafoveal RPE depigmentation that spares the fovea. The exact mechanism responsible for the development of this pattern is not fully understood, however, it is believed that the primary damage is in the photoreceptors and outer nuclear layer leading to secondary disruption of the RPE.

Eligibility criteria: Inclusion Criteria:

* Patients on hydroxychloroquine therapy who came for their ophthalmology screening appointment irrespective of the duration of use of the medication.

Exclusion Criteria:

* Patients who have stopped their hydroxychloroquine medication.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by clinical signs and ancillary tests
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: The Eye Center
Study officials:
References: