louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02401087: The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis
Official title: The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicocele
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be identified as potentially were to be enrolled in the preoperative anesthetic visit.

Brief summary: The aim of this observational study was to evaluate, based on the intraoperative anesthetic that is routinely carried out at the Department of Day Surgery, the difference in timing of the patient's discharge from the hospital (ie when the patient has autonomous demabulation and urination spontaneous) in patients undergoing correction of varicocele according Marmar.


Eligibility criteria: Inclusion Criteria:

* Male
* ASA I-II
* No mental alteration

Exclusion Criteria:

* Chronic pain
* Allergies to local anaesthetics, acetaminophen,oppioids
* ASA III - IV
* Postoperative discharge to ICU
* Epatic or renal failure
* Mental status alteration
* Coagulopathy

Primary outcomes:
measure: discharge time
timeFrame: one day
Secondary outcomes:
measure: Difference in the onset of acute post-operative pain
timeFrame: four days
measure: Check the occurence of any side effects
timeFrame: three months
measure: Clinical evaluation of patients at 1 and 3 months after surgery (possibility of chronic pain)
timeFrame: three months
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Day Surgery Ospedale di Circolo Varese
state: VA
Study officials:
affiliation: University Hospital Varese
name: Stefania Turconi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02115087: Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
Official title: The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: laparotomy
levobupivacaine
patient controlled analgesia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Detailed description: Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* 3-15 years of age children
* Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

Exclusion Criteria:

* ASA physical status III and above
* Parents who did not consider to participate in the study
* Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure

Primary outcomes:
measure: Pain Scores on the FLACC scale
timeFrame: Twenty-four hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Department of Anesthesiology, Cukurova University Faculty of Medicine
Study officials:
affiliation: Department of Anesthesiology, Cukurova University Faculty of Medicine
name: Dilek Ozcengiz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.
Clinical trial NCT04036487: Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
Official title: Chimay Plastic Surgery Clinic, Taipei
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Inhalation Anesthesia
Total Intravenous Anesthesia
Quality of Recovery
Lead sponsor: Chimay Plastic Surgery Clinic
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.


Eligibility criteria: Inclusion Criteria:

* Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
* Age between 20-65 years
* Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System

Exclusion Criteria:

* Having difficulty reading or hearing
* Diagnosed with addictive disorder
* Diagnosed with psychiatric disorder
* Physical Status III-VI as defined by the ASA Physical Status Classification System
* Presence of acute infection or inflammatory condition (e.g., fever).

Primary outcomes:
measure: Quality of recovery, postoperative day one
timeFrame: On the 1st postoperative day
measure: Quality of recovery, postoperative day two
timeFrame: On the 2nd postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chimay Plastic Surgery Clinic
Study officials:
References:
Clinical trial NCT01444287: Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.


Eligibility criteria: Inclusion Criteria:

* Be of legal age (i.e. ≥ 18 years).
* Be mentally competent, willing and able to sign a written informed consent form.
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
* Have spectacle astigmatism \<1.25D in each eye.
* Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion Criteria:

* Required concurrent ocular medication.
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial.

Primary outcomes:
measure: Corneal Thickness
timeFrame: After 8 hours of contact lens wear
measure: Endothelial Blebs
timeFrame: baseline, after 20 minutes of treatment conditions
measure: Limbal Redness
timeFrame: Baseline, After 8 hours of treatment conditions
Secondary outcomes:
measure: Overall Comfort
timeFrame: after 8 hours
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Coles-Brennan Pty Ltd
state: Victoria
Study officials:
affiliation: Coles-Brennan Pty Ltd
name: Noel Brennan, McOptom PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107987: Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Official title: An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysglycemia
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

Detailed description: Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

The investigators will enroll patients with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Reglicem® and placebo will be self-administered once a day, 1 tablet during the breakfast.

Eligibility criteria: Inclusion Criteria:

* Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
* Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.

Primary outcomes:
measure: Progression of dysglicemia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lombardia
Study officials:
References:
Clinical trial NCT02813187: Venous Leg Ulcer and Lymphedema Registry
Official title: A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Stasis Ulcer
Quality of Patient Care
Keywords: venous leg ulcer
venous
QCDR
quality measure
wound
Outcome
Lymphedema
Lead sponsor: U.S. Wound Registry
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry

Brief summary: This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

Detailed description: This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National bench marking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Eligibility criteria: Inclusion Criteria:

* All patients with venous leg ulcers seen by the practitioner.

Exclusion Criteria:

* None

Primary outcomes:
measure: Wound Healing
timeFrame: 12 months
Secondary outcomes:
measure: Weeks of Therapy
timeFrame: 12 months
measure: Adverse events during therapy
timeFrame: 12 months
measure: Patient Reported Outcome
timeFrame: 12 months
measure: Venous Insufficiency
timeFrame: 12 months
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: CHI St. Luke's The Woodlands
state: Texas
Study officials:
References:
Clinical trial NCT03491787: Ultrasound-guidance for Intraosseous Access During Earthquake
Official title: Ultrasound-guidance for Intraosseous Access Could Provide Benefits for Resuscitation in Out-of-hospital Traumatic Cardiac Arrest: a Field Report During Earthquake on Amatrice (Italy), August 24, 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest Due to Trauma (Disorder)
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People under the rubble, after the earthquake

Brief summary: The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest

Detailed description: The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, decreasing the time for drug administration and providing some benefits during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* traumatic cardiac arrest

Exclusion Criteria:

* non traumatic cardiac arrest
* beheading
* post-mortem hypostasis
* carbonized bodies
* dismembered bodies

Primary outcomes:
measure: Intraosseus access
timeFrame: up to 10 minutes
Secondary outcomes:
measure: Return of spontaneous circulation
timeFrame: up to 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00930787: Hernia Repair in Multiply Morbid Patients
Official title: A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ventral Hernia
Keywords: hernia repair, surgical mesh, co-morbidities
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.


Eligibility criteria: Inclusion Criteria:

* Adults of either gender
* must have 2 or more co-morbidities

Exclusion Criteria:

* local or systemic infection
* expected survival of \<24 months
* non-ambulatory

Primary outcomes:
measure: Incidence of Surgical Site Events (SSEs)
timeFrame: Postoperative Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana Status University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: West Roxbury
country: United States
facility: Boston Veterans Administration Healthcare System
state: Massachusetts
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Lake Success
country: United States
facility: Long Island Jewish - North Shore
state: New York
city: Cleveland
country: United States
facility: University Hospital - Case Western
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Temple
country: United States
facility: Scott & White Medical Center
state: Texas
Study officials:
affiliation: Oregon Health and Science University
name: Robert Martindale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06510387: Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients
Official title: Comparison of Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients, A Cross-Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Two Bedside
Ultrasound
Endotracheal Tube
Intensive Care Patients
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 years old, of both sexes undergoing endotracheal intubation admitted to the emergency and traumatology department ICU between October 2023 to September 2024.

Brief summary: This cross-sectional observational study aims to predict the sensitivity and specificity of ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of endotracheal tubes compared to standard methods in intensive care patients.

Detailed description: Endotracheal intubation is the primary medical procedure used for securing the airway, confirmation of endotracheal tube (ETT) placement is essential to prevent hypoxia and aspiration. The best primary approach to confirm endotracheal tube placement is observation of the tube passage through the vocal cords followed by assessment based on chest and epigastric auscultation.

Ultrasound machines are now increasingly available in emergency departments and intensive care units. It is a non-invasive, portable and serves as a real-time diagnostic tool with rapid and accurate results.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old.
* Both sex.
* All patients requiring prophylactic airway management e.g (patient with Glasgow Coma Scale \<8) with endotracheal intubation in the intensive care unit.

Exclusion Criteria:

* An abnormal airway anatomy.
* Tracheal or endobronchial lesion.
* Significant cervical trauma.
* Cervical abnormality.
* Neck swelling.
* Patients who need cardiopulmonary resuscitation.

Primary outcomes:
measure: Accuracy to predict correct placement
timeFrame: 5 minutes after placement of endotracheal tube
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: