louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03949686: Erector Spinae Plane Block for Congenital Hip Dislocation Surgery
Official title: Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Hip Dysplasia
Keywords: Postoperative Analgesia
Ultrasound guided erector spinae plane block
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in pediatric patients undergoing CHD surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* Incomplete patient forms
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* ASA III-IV

Primary outcomes:
measure: Face, Legs, Activity, Cry and Consolability Score (FLACC)
timeFrame: Postoperative first 24hour
Secondary outcomes:
measure: Need for rescue analgesic
timeFrame: 2 hour
measure: Need for analgesic
timeFrame: 24 hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Elkoundi A, Bentalha A, Kettani SEE, Mosadik A, Koraichi AE. Erector spinae plane block for pediatric hip surgery -a case report. Korean J Anesthesiol. 2019 Feb;72(1):68-71. doi: 10.4097/kja.d.18.00149. Epub 2018 Aug 24.
citation: Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
Clinical trial NCT04963686: Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients
Official title: Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Systolic Dysfunction
Septic Shock
Keywords: Left ventricular systolic function
global longitudinal strain
Septic Shock
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock. Patient with a transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock.

Brief summary: The assessment of left ventricular systolic function is based on the measurement of left ventricular ejection function (LVEF) by the Simpson biplane method. More recently, left ventricular global longitudinal strain (GLS) has been developed to detect abnormalities of cardiac contractility in patients with preserved myocardial contractility. However, both tools are not always easy to collect in practice. This is why other ultrasound parameters have been proposed in the literature as a substitute for LVEF and GLS such as the Doppler tissue imaging (DTI)-derived mitral annular systolic peak S-wave velocity (S'), the mitral annular plane systolic excursion (MAPSE) and the longitudinal wall fractional shortening index (LWFS).

The purpose of this project is to propose an algorithm using simple parameters (S' wave, lateral MAPSE, septal MAPSE, mean MAPSE and LWFS) to predict LVEF and GLS in order to diagnose patients with impaired systolic function and preserved ejection.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock.
* Septic shock is defined by sepsis with a need for vasopressor amines to maintain a mean arterial pressure higher than or equal to 65 mmHg, and associated with hyperlactatemia (higher than 2 mmol/L).
* A transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock.

Exclusion Criteria:

* Patient with cardiac arrhythmias,
* patients with severe mitral or aortic valve disease,
* patients with fused mitral Doppler flow,
* patients with insufficient echogenicity to allow a correct assessment of left ventricular systolic function.

Primary outcomes:
measure: Concordance between LVEF and echocardiographic algorithm
timeFrame: 3 months
measure: Concordance between GLS and echocardiographic algorithm
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05692986: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
Official title: Randomized Control Trial: Chlorhexidine vs Povidone Iodine Vaginal Prep in Decreasing Postoperative Infection in Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preventative Laparoscopic Hysterectomy
Keywords: 4% chlorhexidine
10% povidone iodine
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized control trial which will randomize patients who will be undergoing laparoscopic (conventional or robotic assisted) total hysterectomy to vaginal prep with 4% chlorhexidine gluconate vs 10% povidone iodine. There is paucity of information regarding the superiority of one over the other.

Detailed description: This is a randomized control trial. During surgery, preoperative vaginal prep is routinely done for hysterectomies. This can be completed with 10% povidone iodine or with 4% chlorhexidine preparation. This study will investigate whether the routine use of betadine vaginal prep in comparison to chlorhexidine prep is superior. Patients will be informed of the study at the time of their preoperative visit in the gynecology clinic at time of surgical scheduling. The attached informed consent sheet will be given to the patient for their signature. The patients will be randomized to receive either 10% povidone iodine or with 4% chlorhexidine vaginal preparation solution. This is not anticipated to take extra time or resources in the operating room setting because the surgical vaginal preparation solutions are typically readily available in the operating room setting. The patients will be assigned an envelope when they are in clinic after they have signed the consent form and that will be the group they are randomized to.

Once the patients are randomized, it is anticipated that 50 patients will be enrolled in each study arm. Following randomization patients will receive the vaginal preparation per the randomization assignment. The patient will be blinded to the study arm. The provider will not be blinded. Follow-up will occur on postoperative day #1 by phone call, and at the 2-week and 6-week follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for total laparoscopic hysterectomy

Exclusion Criteria:

* not able to consent in English or have allergy to the 10% povidone betadine or 4% chlorhexidine solution.

Primary outcomes:
measure: The number of positive cultures in each arm will be compared.
timeFrame: before antibiotic administration, 30 minutes after vaginal prep and q1hr thereafter until the surgery was completed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02292186: A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Official title: A Phase 2, Open-label Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTRSC in Patients With Transthyretin (TTR) Cardiac Amyloidosis Who Have Previously Received ALN-TTRSC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: TTR-mediated Amyloidosis
Keywords: Cardiomyopathy
Heart Failure
FAC
Amyloid
Transthyretin
TTR
RNAi therapeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and clinical activity of long-term dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being followed-up for safety.


Eligibility criteria: Inclusion Criteria:

* Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the ALN-TTRSC-002 study
* Adequate liver function
* Not Pregnant or nursing

Exclusion Criteria:

* Inadequate renal function
* Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac arrhythmia
* Untreated hypo- or hyperthyroidism
* Prior major organ transplant

Primary outcomes:
measure: Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.
timeFrame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months
measure: Serum TTR Levels
timeFrame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months
Secondary outcomes:
measure: Mortality
timeFrame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months
measure: Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization
timeFrame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months
measure: 6-minute Walk Test Performance
timeFrame: Baseline, Month 6, and Month 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Cleveland
country: United States
facility: Clinical Trial Site
state: Ohio
city: Calgary
country: Canada
facility: Clinical Trial Site
state: Alberta
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Jared Gollob, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03706963: Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery
Official title: Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Surgery
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
name: BJC Innovative Lab
First posted: 2018-10-16
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is data confirming that simple tests of physical capability, such as the timed "get-up-and-go" test and the 6-minute walk test, correlate with surgical outcomes. It is reasonable to assume that preoperative telemonitoring, which allows for the tracking of more variables over a wider range of activities, could provide a significantly more accurate picture of a patient's physical fitness than a short one-time test performed in the clinic setting.

Almost half of the patients who are readmitted at Washington University are readmitted for less than 4 days. The readmitted patients usually present with sepsis, are treated with antibiotics and percutaneous drainage, and are discharged home relatively quickly. Earlier identification of these patients, prior to the development of sepsis, would reduce the risks to the patient and allow for outpatient management.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo elective abdominal surgery
* At least 18 years of age
* Able to understand and willing to sign an IRB-approved informed consent document

Exclusion Criteria:

* Doesn't have access to smartphone

Primary outcomes:
measure: Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day
timeFrame: Baseline through 30 days after surgery discharge (approximately 45 days)
measure: Patient compliance of telemonitoring with activity trackers as measured by percentage of time the patient is wearing the device properly
timeFrame: Baseline through 30 days after surgery discharge (approximately 45 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Chet Hammill, M.D., MCR, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05662163: Effect of General Anesthesia Method on Cardiac Risk Patients on Ischemia Modified Markers
Official title: Effect of General Anesthesia Method Chosen in Non-cardiac Surgery of Cardiac Risk Patients on Ischemia Modified Albumin and Heart-Type Fatty Acid-Binding Protein (H-FABP) Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To examine the effects of the general anesthesia method chosen in non-cardiac surgical operations of patients with cardiac risk on the levels of cardiac markers

Detailed description: To examine the effects of the general anesthesia method chosen in non-cardiac surgical operations of patients with cardiac risk on the levels of cardiac markers like; serum levels of the Creatine Kinase, Creatine Kinase Myocardial Band, high sensitive troponin, heart-type fatty acid-binding protein, ischemia-modified albumin and albumin. And evaluate the effect of anesthesia method on haemodynamic.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Getting a score of 2 and above according to the Lee cardiac index
* Having a non-cardiac surgical procedure that will take at least three hours
* ASA II or III

Exclusion Criteria:

* Under 18 years old
* Those who refused to participate in the study
* Patients with chronic renal failure
* Patients with creatinine value ≥ 1.5 mg/dl
* Surgery that takes less than 3 hours
* Patients with liver failure
* Refusing to participate in the study
* Being allergic to the drugs used

Primary outcomes:
measure: comparing serum levels of ischemia modified albumin
timeFrame: intraoperative period
measure: comparing serum levels of heart fatty acid binding protein
timeFrame: intraoperative period
Secondary outcomes:
measure: The effect of anesthesia method used in cardiac risk patients in terms of ephedrine consumption
timeFrame: intraoperative period
Other outcomes:
Locations:
Study officials:
affiliation: Ataturk University
name: Canan Atalat
role: STUDY_DIRECTOR
References:
Clinical trial NCT01624363: Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound
Official title: Prevalence of Pancreatic Cysts During Routine EUS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cysts
Keywords: Pancreatic cysts incidentally found during EUS
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were identified on the day of scheduled endoscopy.

Brief summary: The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

Detailed description: The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included: patients \>18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass.

Exclusion Criteria:

* Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct
* Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas
* Laboratory and/or clinical evidence of ongoing acute pancreatitis
* Previous pancreatic surgical resection
* Pregnancy
* Incarceration
* High risk for sedation
* Coagulopathy and/or thrombocytopenia
* The patients underwent a complete EUS examination of the pancreas.

Primary outcomes:
measure: Prevalence of Pancreatic Cysts During Routine EUS
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: John M. DeWitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sey MS, Teagarden S, Settles D, McGreevy K, Cote GA, Sherman S, McHenry L, LeBlanc JK, Al-Haddad M, DeWitt JM. Prospective Cross-Sectional Study of the Prevalence of Incidental Pancreatic Cysts During Routine Outpatient Endoscopic Ultrasound. Pancreas. 2015 Oct;44(7):1130-3. doi: 10.1097/MPA.0000000000000408.
Clinical trial NCT03180463: The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)
Official title: The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Osteonecrosis of Femoral Head
Keywords: Osteonecrosis of Femoral Head
umbilical cord mesenchymal stem cells
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

Detailed description: This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.

Eligibility criteria: Inclusion Criteria:

* Ficat classification is I, IIa, or IIb period
* no obvious improvement or ingravescence by conservative treatment
* patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Exclusion Criteria:

* Ficat classification is third or fourth period
* acute, chronic infection patients
* combined with heart, lung, kidney disease, and cannot tolerate operation
* ankylosing spondylitis patient
* acetabular dysplasia patient
* with tumor
* clinical data deficient
* HIV positive
* pregnancy or breast feeding women
* under other therapy that possibly influence MSC security or efficacy

Primary outcomes:
measure: MRI imageological examination
timeFrame: 6 months
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
Study officials:
affiliation: Inner Mongolia International Mongolian Hospital
name: Bahushan
role: STUDY_DIRECTOR
affiliation: China-Japan Union Hospital, Jilin University
name: Lei Guo, Dr.
role: STUDY_CHAIR
References: