louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02941952: Comparative Noninvasive Continuous Cardiac Output by the Clearsight® With Invasive Monitoring by PICCO® in Abdominal Major Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output Measurement
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the transpulmonary thermodilution and the arterial waveform analysis in the radial artery by PICCO®.

This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in radial artery by PICCO® in abdominal major surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo major abdominal surgery
* Patients monitored by a PICCO® device

Exclusion Criteria:

* Patients with heart rhythm disorder
* Patients with Raynaud's disease or vasculitis
* Emergency surgery
* Significant edema fingers

Primary outcomes:
measure: Stroke ejection volume (SEV) measure by ClearSight®
timeFrame: 24 hours
measure: Stroke ejection volume measure by PICCO®
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Matthieu BOISSON
Study officials:
References:
Clinical trial NCT05008952: Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity
Official title: Postprandial Triglycerides, Endothelial Function, and Inflammatory Cytokines as Potential Candidates for Early Risk Detection in Normal-weight Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 study groups: control (normal body mass index, low body fat percentage), normal-weight obesity ((normal body mass index, high body fat percentage), and metabolic syndrome
Primary purpose: SCREENING

Brief summary: The purpose of this study is to identify early cardiovascular disease risk factors in those with "normal-weight obesity" (i.e., normal body, but high body fat percentage) that better track with their long-term cardiovascular disease risk.


Eligibility criteria: Inclusion Criteria:

Control group: normal BMI, body fat percentage \< 25% for men and 35% for women

Normal-weight obesity group: normal BMI, body fat percentage \> 25% for men and 35% for women

Metabolic syndrome group: BMI \> 30 and 2 or more of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).

Exclusion Criteria:

* Presence of pacemaker
* Pregnant
* use of tobacco products
* using lipid lowering drugs

Primary outcomes:
measure: 4-hour triglycerides after fat tolerance test
timeFrame: Within 2 weeks of study enrollment
Secondary outcomes:
measure: Flow-mediated dilation
timeFrame: Within 2 weeks of study enrollment
measure: Fasting serum cytokines
timeFrame: Within 10 months of study enrollment
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT06505759: Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT
Official title: Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Periodontal Pocket
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

Detailed description: 36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into

1. Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
2. Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
3. Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel.

periodontal pack was placed and patient was recalled at 1week,4th week and 12th week

Eligibility criteria: Inclusion Criteria:

* Patient with have chronic periodontitis in the age group between 30-50 years.
* Patients having ≥20 teeth.

  -.Patients with radiographic evidence of bone loss in atleast two teeth.
* Patients who are systematically healthy.
* Patients with localized pockets with probing depth of ≤ 5mm.
* Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion Criteria:

* Patients who have received any surgical or nonsurgical therapy during past 6months
* Pregnant or lactating females.
* Use of systemic antibiotics in the past 6 months.
* Patient who are not willing to give a written informed consent

Primary outcomes:
measure: Probing pocket Depth (PPD)
timeFrame: 3 months
measure: Relative attachment level (RAL)
timeFrame: 3 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 3 months
measure: Gingival index
timeFrame: 3 month
measure: Modified Sulcus Bleeding Index
timeFrame: 3 months
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
state: Karnataka
Study officials:
References:
Clinical trial NCT05550259: Ventilation Support for the PREvenTion of EXTubation Failure
Official title: Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extubation Failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A stepped wedge cluster randomized trial
Primary purpose: TREATMENT

Brief summary: Reintubation after failed extubation would be associated with increased mortality. Therefore, extubation failure remains a major concern in ICU. Few randomized controlled studies have assessed the benefit for a systematic respiratory support (noninvasive ventilation or high flow nasal cannula) applied at the time of extubation to reduce reintubation rates in patients at high and low risk for reintubation. In addition, these studies reported discordant results. Therefore, there are some concerns regarding effectiveness and systematic uptake of a respiratory support after extubation into usual practice.

Detailed description: The aim of this trial is to determine whether a protocolized postextubation respiratory support including High-flow Nasal Oxygen (HFNO) and Noninvasive Ventilation (NIV) could reduce the rate of reintubation in comparison with usual practice. Therefore, all consecutively eligible patients for the study, will be assigned to a protocol arm in accordance with the randomized period

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Intubated more than 24 hours in the ICU
* Ready for a scheduled extubation then extubated

Exclusion Criteria:

* Contraindication to HFNO or NIV
* Underlying chronic neuromuscular disease
* Unplanned extubation (accidental or self-extubation)
* With a do-not-reintubate order at time of extubation
* Tracheotomia

Primary outcomes:
measure: Rate of reintubation
timeFrame: 7 days following extubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02521259: Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Official title: The Correlation Between Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Keywords: anesthetic depth
emergence agitation
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged between 3 and 5 years, scheduled for strabismus surgery

Brief summary: This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.

Detailed description: EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.

Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head \& neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.

The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.

In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.

Eligibility criteria: Inclusion Criteria:

* aged between 3 and 5 years
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* American Society of Anesthesiologists physical status over III,
* any disease that could affect mental status
* pre-existing forehead wound

Primary outcomes:
measure: the Pediatric Anesthesia Emergence Delirium (PAED) Score
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, department of Anesthesia and pain
state: Gyenggo-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: HYO SEOK NA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03487159: Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Official title: Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-04-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study model includes 2 study arms:

1. Patients with chronic liver diseases who will undergo a routine liver biopsy, Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage.
2. Patients with chronic liver diseases who will undergo a routine Shear Wave elastography and the MRE in order to evaluate the liver fibrosis stage.

Demographic and clinical information will be collected from the patient's medical files.
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.

Detailed description: Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver diseases

Exclusion Criteria:

* Patients who don't have chronic liver diseases

Primary outcomes:
measure: Liver Biopsy Result for liver fibrosis grade
timeFrame: Patient will undergo Liver biopsy once during 1 year of the study.
measure: Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade
timeFrame: Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.
measure: Shear Wave Elastography Result for liver fibrosis grade
timeFrame: Patient will undergo Shear Wave Elastography once during 1 year of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Liver Diseases Center, Sheba M.C
name: Ziv Ben-Ari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212159: Telephone Based Management of Hyperlipidemia
Official title: Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Keywords: Internet based monitoring system
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate that systematic self measurement of blood lipids reduces LDL cholesterol more effectively than standard care. The hypothesis is that cholesterol lowering medication adherence will be improved with self monitoring and reporting of frequent blood lipids and the percentage of patients achieving LDL goal will be greater than without home monitoring.

Detailed description: The study utilizes a telephone reporting system to self report lipid values and provide educational counseling regarding lifestyle modification methods to reduce cardiovascular risk. Study patients will be randomized to receive a home monitoring device and will be instructed on its use. Generic simvastatin will be given to reduce LDL levels in all groups. It is the hypothesis that those study patients receiving a home device will reach target LDL (goal LDL) more frequently than those randomized to usual care( no device).

Eligibility criteria: Inclusion Criteria:

* LDL \> 130mg/dl

Exclusion Criteria:

* Pregnant patients
* liver disease
* allergic reaction to statins

Primary outcomes:
measure: LDL Level Change From Baseline
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Medication Compliance
timeFrame: 6 months
measure: LDL Values at Two Week Interval
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02033759: Patient Anxiety Associated With Lymphedema Surveillance Method
Official title: A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Lymphedema
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: We propose to study the impact of BIA screening on anxiety and primary prevention strategies for lymphedema development among patients with recent surgery for breast cancer. Currently, professional societies recommend scheduled follow-up visits to screen for lymphedema after recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk reduction strategies, measurement of the affected limb with a tape measure, and physical inspection for physical changes consistent with lymphedema. In the proposed study, patients will be randomly assigned to the addition of BIA screening vs. usual care. At each screening visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior studies of patients with breast cancer (8,9). This questionnaire will be administered at each follow-up lymphedema screening visit, and the baseline will be administered at the preoperative visit. For patients randomly assigned to BIA screening, this involves the placement of adhesive electrodes on the each wrist and an ankle, followed by connection of the electrodes to the BIA machine, which then uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors and anxiety levels between those patients with vs. without BIA screening.


Eligibility criteria: Inclusion Criteria:

* Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker

Primary outcomes:
measure: Anxiety
timeFrame: 6 weeks post-op
measure: Anxiety
timeFrame: 3 months post-op
measure: Anxiety
timeFrame: 6 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Creve Coeur
country: United States
facility: Mercy Clarkson/Clayton
state: Missouri
Study officials:
References:
Clinical trial NCT01871259: Clinical Predictors of Apnea-hypopnea During Propofol Sedation
Official title: Clinical Predictors of Apnea-hypopnea During Propofol Sedation in Patients Undergoing Spinal Anaesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep Apnea
Keywords: Sedation, sleep apnea, propofol
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 29
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We expected a correlation coefficient of \~0.5 in this study, which meant that for a level of significance of 5% and a power of 80%, we required 29 analyzable subjects. Based on a predicted exclusion rate of 15%, 34 patients were included.

Brief summary: To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.

Detailed description: The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI. After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.

Eligibility criteria: Inclusion Criteria:

* Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.

Exclusion Criteria:

* Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.

Primary outcomes:
measure: Apnea hypopnea index
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: : Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Jeong Jin Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References: