louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01799785: Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
Official title: Aerobic Training in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤70 years
* Cirrhosis
* Child Pugh class A or B
* If required, primary or secondary variceal prophylaxis in place

Exclusion Criteria:

* Post-liver transplantation
* Hepatocellular carcinoma
* Active non-Hepatocellular carcinoma malignancy
* Significant cardiac disease - ejection fraction \<60% or known coronary artery disease
* Oxygen saturation at rest \<95%
* Known myopathy
* Hemoglobin (\<100 g/L)
* Chronic renal failure on dialysis
* Physical impairment making it impossible to ride an exercise bike or treadmill
* Orthopedic abnormality preventing exercise training
* HIV infection
* Patient unwilling to consent to study

Primary outcomes:
measure: Change in peak exercise pulmonary oxygen uptake (peak VO2)
timeFrame: Baseline (day 1) and Study End (8 weeks)
Secondary outcomes:
measure: Change in muscle mass as measured by thigh ultrasound
timeFrame: Baseline (day 1) and study end (8 weeks)
measure: Change in Quality of Life - Chronic Liver Disease Questionnaire
timeFrame: Baseline (day 1) and Study End (8 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Mazankowski Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Mark Haykowsky
role: STUDY_DIRECTOR
References:
citation: Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
Clinical trial NCT01548885: Comparison Evaluation of Blood Glucose Meter Systems
Official title: Evaluation of Blood Glucose Meter Systems - NACT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.


Eligibility criteria: Inclusion Criteria:

* Males and females
* 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy

Primary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
timeFrame: 10 hours
Secondary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)
timeFrame: 10 hours
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05851885: Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System
Official title: A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopy, Gastrointestinal
Artificial Intelligence
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years
2. Aim to undergo screening, surveillance, and diagnosis
3. Undergo sedated EGD
4. Able to read, understand, and sign informed consent

Exclusion Criteria:

1. EGD contraindications
2. Not suitable for sedated endoscopy after anaesthesia evaluation
3. Biopsy contraindications
4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
5. Pregnancy
6. Upper gastrointestinal surgery or residual stomach
7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

Primary outcomes:
measure: Completeness of reporting lesions
timeFrame: one month
Secondary outcomes:
measure: Completeness of report drafting on lesion features
timeFrame: one month
measure: Accuracy of report drafting on lesion features
timeFrame: one month
measure: Reporting time
timeFrame: one month
measure: Completeness of reporting lesions of AI system
timeFrame: one month
measure: Accuracy of report drafting on lesion features of AI system
timeFrame: one month
measure: Physician satisfaction survey
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan University Renmin Hospital
name: Honggang Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03483285: Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey
Official title: Videolaryngoscopes in Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Coronary Bypass
Keywords: intubation
airtraq
open heart surgery
hemodynamic parameters
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Detailed description: Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.

Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this prospective.randomized study. Demogaphic variables and airway characteristics of patients were recorded. Glottic visulisation and intubation time were recorded. Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2 minutes intervals before intubation, after intubation during 10 minutes.

Eligibility criteria: Inclusion Criteria:

* patients undergoing open heart surgery
* \< 18 years of age

Exclusion Criteria:

* emergency

Primary outcomes:
measure: heart rate
timeFrame: 2 months
Secondary outcomes:
measure: insertion time
timeFrame: 2 months
measure: intubation time
timeFrame: 2 months
measure: mean arterial pressure
timeFrame: 2 months
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
affiliation: Anesthesiology and Reanimation
name: Tulay Cardakozu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852485: Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
Official title: Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes and Eyes With Ocular Pathologies
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine care

Brief summary: Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed description: The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Eligibility criteria: IInclusion Criteria:

* Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
* Glaucoma - Have glaucoma and no history of other retinal pathology.
* Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
* Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria:

* Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
* Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
* Retina - Unable to complete required exams.
* Cornea - Unable to complete required exams.

Primary outcomes:
measure: Limits of agreement
timeFrame: Day 1
Secondary outcomes:
measure: Regression Analysis
timeFrame: Day 1
Other outcomes:
Locations:
city: Newark
country: United States
facility: IOVS
state: New Jersey
city: Marysville
country: United States
facility: AMA
state: Ohio
Study officials:
References:
Clinical trial NCT05521685: Impact of EUS Guided Treatment of Gastric Varices
Official title: Impact of EUS Guided Treatment of Gastric Varices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Varices Bleeding
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were treated for Gastric Varices with bleeding using cyanoacrylate tissue adhesive and administered by endoscopic ultrasound.

Brief summary: The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for Gastric Varices performed by Indiana University EUS physicians.

Detailed description: Using an IRB approved database (IU IRB#1209009522; NCT02037659), data collected from the database will be evaluated to identify complications, risk of rebleeding, death within 1 year of treatment, varices eradication and need for re-intervention associated with cyanoacrylate tissue adhesive (Dermabond) treatment performed by Indiana University Endoscopic Ultrasound (EUS) physicians.

Eligibility criteria: Inclusion Criteria:

* Any subject enrolled into the existing database (IU IRB#1209009522; NCT02037659).

Exclusion Criteria:

* Not enrolled into the database.

Primary outcomes:
measure: Impact of EUS guided treatment of Gastric varices post procedure complications and adverse events
timeFrame: Complications reviewed at time of retrospective study. EUS-guided sclerotherapy done between November 2012 and December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Professor of Medicine and Director of Endoscopic Ultrasound
name: John M. DeWitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810285: Total Knee Arthroplasty With Vitamin E Polyethylene
Official title: Total Knee Arthroplasty With Vitamin E Polyethylene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
vitamin E
polyethylene
aseptic loosening
osteolysis
Lead sponsor: Permedica spa
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing

Brief summary: The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up


Eligibility criteria: Inclusion Criteria:

* Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing.
* Minimum 7-year follow-up;
* Age ≥ 18 and \< 85 years;
* Patient who signed informed consent.

Exclusion Criteria:

* Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design;
* Patient already enrolled in other clinical studies.

Primary outcomes:
measure: Implant Survival for Aseptic Loosening
timeFrame: 10-year follow-up
Secondary outcomes:
measure: Implant Survival for Any Reason
timeFrame: 10-year follow-up
measure: Forgotten Joint Score (FJS-12)
timeFrame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
measure: American Knee Society Score (KSS)
timeFrame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
measure: Periprosthetic Radiolucent Line
timeFrame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
measure: Periprosthetic Osteolysis
timeFrame: At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Other outcomes:
Locations:
city: Omegna
country: Italy
facility: Ospedale Centro Ortopedico di Quadrante
state: Verbania
Study officials:
affiliation: Ospedale Centro Ortopedico di Quadrante
name: Marco Spezia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05494385: Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Official title: Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.


Eligibility criteria: Inclusion Criteria:

* Women \> 18 years old
* English-speaking
* Stage \> 2 pelvic organ prolapse
* Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
* Planning overnight stay

Exclusion Criteria:

* Renal dysfunction (creatinine clearance \<60 mL/min)
* Allergy to acetaminophen and ibuprofen
* Allergy to gabapentin
* Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.

Primary outcomes:
measure: Opioid Prescription at Discharge
timeFrame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
Secondary outcomes:
measure: Opioid Refill Requests
timeFrame: 6 weeks
measure: Inpatient Pain Scores
timeFrame: Length of postoperative hospital stay (an average of 32 hours following surgery)
measure: Inpatient Morphine Milligram Equivalents
timeFrame: Length of postoperative hospital stay (an average of 32 hours following surgery)
measure: Length of Stay
timeFrame: Time of registration for surgery to time of discharge from hospital
measure: Nausea
timeFrame: Length of postoperative hospital stay (an average of 32 hours following surgery)
measure: Sedation
timeFrame: On postoperative day 1 between 6AM and 10AM
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Douglass S Hale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564785: Synera™ for Epidural Needle Insertion
Official title: A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Associated With Epidural Needle Insertion
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2007-11-28
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.


Eligibility criteria: Inclusion Criteria:

* older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural

Exclusion Criteria:

* hypersensitivity to any study medications

Primary outcomes:
measure: Subject VRS (0 - 11) with epidural needle insertion
timeFrame: 1 hour
Secondary outcomes:
measure: Anesthesia provider perceived VRS
timeFrame: 1 hour
measure: Need for deep infiltration with local anesthesia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: IWK Health Centre
name: Ronald B George, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: