louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06805032: Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs
Official title: Accuracy and Precision of Train-of-Four Ratios Obtained With Acceleromyography and Electromyography in Restricted-Movement Settings in the Absence of Neuromuscular Blocking Drugs
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cystoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 40
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 undergoing elective surgery and requiring general anesthesia without administration of neuromuscular blocking agents.

Brief summary: The purpose of this research is to compare the performance of acceleromyograph and electromyograph-based quantitative neuromuscular monitors when the arms are tucked for surgical positioning.


Eligibility criteria: Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require general anesthesia without use of NMBA agents administered intraoperatively, and tucked arms.
* Anticipated surgery duration \< 120 minutes.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients having surgery that would involve prepping the arm into the sterile field.

Primary outcomes:
measure: Accuracy and precision
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J. Ross Renew, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604432: Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
Official title: Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.

Detailed description: This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.

The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.

A total of 60 subjects will be enrolled in this study at a single site.

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery
* AVR
* CABG
* AVR/CABG

Exclusion Criteria:

* History of AF/Aflutter
* Less common cardiac surgeries:
* aortic root replacement
* aortic dissections
* myxoma
* pericardectomies
* off-pump procedures
* redo procedures
* Subjects with existing pacemakers, AICD
* Vulnerable population
* Emergent surgery
* Currently participating in investigational drug or device study.
* Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.

Primary outcomes:
measure: Incidence of Documented Post-operative Atrial Fibrillation
timeFrame: From date of index surgical procedure to date of discharge, on average 1 week.
Secondary outcomes:
measure: Number of Participants Requiring Antiarrhythmic Medications in the Treatment Group Versus Control Group
timeFrame: immediately after procedure/surgery up to discharge from the hospital, average 1 week
measure: Percentage of Adverse Events Related to Use of the Radiofrequency Device or Left Atrial Appendage Amputation.
timeFrame: during the procedure/surgery, up to 8 hours
measure: Number of Participants Requiring Anticoagulants Medications in the Treatment Group Versus Control Group
timeFrame: immediately after procedure/surgery up to discharge from the hospital, on average 1 week
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Charles L Willekes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871632: The China CardioMyopathy Registry Study
Official title: The China CardioMyopathy Registry Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiomyopathies
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-05-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with cardiomyopathy as the primary discharge diagnosis are recruited prospectively from multiple centers in China between July 1, 2023 and June 30, 2025.

Brief summary: Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. Studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.

Detailed description: In this study, patients hospitalized with cardiomyopathy as the primary discharge diagnosis in China are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. Data are collected with the use of case report forms (CRFs) and are entered into a web-based system. A 6 mL venous blood sample is obtained from consenting patients. Each participant is scheduled to be followed up by telephone every 12 months after admission to hospital.

Eligibility criteria: Inclusion Criteria:

* Patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

Exclusion Criteria:

* Patients who refuse to sign the informed consent or decline follow-up.

Primary outcomes:
measure: number of participants with cardiovascular deaths
timeFrame: an average of 1 year
Secondary outcomes:
measure: number of participants with heart failure
timeFrame: an average of 1 year
measure: number of participants with stroke
timeFrame: an average of 1 year
measure: number of participants with myocardial infarction
timeFrame: an average of 1 year
measure: number of participants with all-cause deaths
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03473132: Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
Official title: Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anticoagulation
Anticoagulation Reversal
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2018-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of consecutive patients.
Primary purpose: TREATMENT

Brief summary: Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).

Detailed description: Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..

Eligibility criteria: Inclusion Criteria:

* LVAD on warfarin requiring temporary interruption of anticoagulation for procedures

Exclusion Criteria:

* recent thrombotic event

Primary outcomes:
measure: plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio
timeFrame: through 48 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 30 days
measure: adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women';s Hospital
name: Jean M Connors, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06524037: Relationship Between Metabolic Profiles and Chronic Diseases and Neoplasms
Official title: Relationship Between Metabolic Profiles and Chronic Diseases and Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Diseases
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People undergoing physical examination in the first branch of the First Affiliated Hospital of Chongqing Medical University

Brief summary: Metabolic disorders are involved in the occurrence and development of a variety of chronic diseases and tumors. There are many common risk factors between chronic diseases and tumors. However, the mechanisms of chronic diseases and tumors caused by metabolic disorders are not completely clear. By observing the relationship between metabolic indexes and chronic diseases and tumors, the investigators intend to explore the possible mechanisms of metabolic status participating in the occurrence and development of chronic diseases and tumors.

Detailed description: Metabolic disorders are involved in the occurrence and development of a variety of chronic diseases and tumors, for example, metabolic diseases (hypertension, diabetes, dyslipidemia, obesity, etc.) can mediate the progression of chronic diseases such as heart failure and ischemic encephalopathy. Obesity can increase the risks of endometrial cancer, esophageal cancer, stomach cancer, etc. There are many common risk factors between chronic diseases and tumors, such as age, sex, smoking, genetics, obesity, unhealthy diet and lack of exercise. However, the mechanisms of chronic diseases and tumors caused by metabolic disorders are not completely clear. By observing the relationship between metabolic indexes and chronic diseases and tumors, the investigators intend to explore the possible mechanisms of metabolic status participating in the occurrence and development of chronic diseases and tumors.

Eligibility criteria: Inclusion Criteria:

* adult aged ≥18 years old
* Completed health screening

Exclusion Criteria:

* aged \<18 years old
* pregnancy

Primary outcomes:
measure: metabolic disorder
timeFrame: through study completion, an average of 1 year
measure: Chronic disease
timeFrame: through study completion, an average of 1 year
measure: Tumor
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Branch of the Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
name: Qin Duan, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06375837: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites
Official title: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites in Non-carious Cervical Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests.


Eligibility criteria: Inclusion Criteria:

* Age range will be 18 to 65.
* They will be required to have at least three NCCLs needed restoration in different teeth.
* All the NCCLs selected will be in similar sizes.

Exclusion Criteria:

* Patients with severe periodontal disease
* Patients with rampant, uncontrolled caries
* Patients with xerostomia
* Patients with serious medical problems preventing them from attending review visits
* Patients with poor gingival health
* Patients with heavy bruxism
* Patients with removable partial dentures
* Patients undergoing bleaching treatment or orthodontic treatment

Primary outcomes:
measure: Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)
timeFrame: two years
Secondary outcomes:
measure: Clinical performances of different restorative systems according to FDI criteria (Functional properties)
timeFrame: two years
Other outcomes:
measure: Clinical performances of different restorative systems according to FDI criteria (Biological properties)
timeFrame: two years
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01173237: Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
Official title: Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: tracheal intubation
proseal laryngeal mask airway
neonate
surfactant
respiratory distress syndrome
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.


Eligibility criteria: Inclusion Criteria:

* Birthweight more than 1000 grams
* Gestational age more than 28 weeks and less than 35 weeks
* Chronologic age less than 8 hours
* Diagnosis of RDS by clinical and radiographic criteria
* Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
* Parental consent

Exclusion Criteria:

* Birthweight less than 1000 grams
* Gestational age more than 28 weeks and less than 35 weeks
* Chronologic age more than 8 hours
* Maternal fever or premature rupture of fetal membranes less than 18 hours
* Diagnosis other than respiratory distress syndrome
* Babies who require or have already had endotracheal intubation
* Analgesia and or sedation during the first six hours of life
* Apgar 5 minute score less than three
* Babies with congenital anomalies or signs of acute circulatory failure

Primary outcomes:
measure: Fraction of inspired oxygen
timeFrame: three hours
Secondary outcomes:
measure: Hormonal evaluation of pain
timeFrame: three hours
measure: Proseal laryngeal mask surfactant treatment failure
timeFrame: Six hours
measure: Rate of respiratory distress syndrome complications
timeFrame: 28 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Maternidade Odete Valadares
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Dia e Maternidade Unimed-BH
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Yerkes P Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410137: Influence of Nutritional and Inflammational Status on Survival of Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Body Composition
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: prospective longitudinal measurements of nutritional status parameters (body composition by BIA, anthropometry and biochemical indexes), inflammatory response (CRP, inflammatory cytokines (IL-1, IL-6, IL-10),IGF-1, leptin and NOx blood levels) and morbidity and mortality data collection over 2 year period in patients receiving chronic hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months
* Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V \> 1.2 and/or hemodialysis performed 4 hours 3 times weekly
* Patients with normal hydration status (edema-free), with no neuro-muscular diseases
* Informed consent obtained before any trial-related activities

Exclusion Criteria:

* Patients with edema, pleural effusion or ascites at their initial assessment
* Patients with active malignant disease or liver cirrhosis
* Patients with neuro-muscular diseases
* Patients on chronic treatment with steroids on doses \> 10 mg/day Prednisone (or equivalent)
* Patients treated with immunosuppressive agents
* Patients suffering from

  * Acute vasculitis
  * Severe systemic infections
  * Heart failure (NYHA class III-IV)
* The receipt of any investigational drug within 1 month prior to initiating of this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Ilia Beberashvili, MD
role: PRINCIPAL_INVESTIGATOR
References: