louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03507062: Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia
Official title: Effect of Crystalloids With Different SID on Hemodilution, Plasmatic Acid Base Equilibrium and Urinary Electrolytes in Patients During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SID
Acid-Base Imbalance
Keywords: pH
crystalloids
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Cristina Dominedò
name: Marco Rossi
name: Rossano Festa
name: Nicoletta Filetici
name: Marta Cicetti
name: Domenico Luca Grieco
name: Massimo Antonelli
First posted: 2018-04-24
Enrollment: 45
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: OTHER

Brief summary: The present study will investigate variations in acid base equilibrium caused by the administration of four different crystalloids with increasing strong ion difference (0.9% saline, Ringer's lactate, Ringer's acetate, plasmalyte-like solution) in patients during general anesthesia.

The same crystalloid will be administered throughout the surgery. In order to assess the effect of hemodilution, every patient will receive two fluid boli with different volumes of the same solution. pH and strong ion variations, togher with the renal response to acid base disturbances, will be analysed.


Eligibility criteria: Inclusion Criteria:

* Adult patients (between 18 and 75 years old);
* ASA (American Society of Anesthesiologists) physical status classification system 1 or 2;
* Patients undergoing spinal surgery under general anesthesia, intubated and mechanically ventilated;
* Normal preoperative albumin;
* Surgery with an estimated duration of at least 3 hours.

Exclusion Criteria:

* Patients who are pregnant;
* Patients with obesity (BMI \> 35);
* Patients with a chronic obstructive pulmonary disease (COPD);
* Patients with obstructive sleep apnea (OSA) treated with CPAP;
* Patients with chronic heart failure (CHF) with a NYHA (New York Heart Association) class ≥2;
* Patients receiving diuretics in the pre-operative period;
* Patients with a chronic kidney disease (CKD), defined as a GFR \< 60 ml/min/1.73 m2;
* Patients with diabetes mellitus treated with insulin;
* Patients with myopathies; Patients undergoing a surgery with likely fluid losses or with unexpected bleeding during surgery.

Primary outcomes:
measure: pH modification
timeFrame: Surgery
Secondary outcomes:
measure: Urinary SID modification (mEq/L) after crystalloids administration with different SID and chloride load
timeFrame: Surgery
measure: SID and plasmatic weak acid (A tot) variations measured in mEq/L
timeFrame: Surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico A. Gemelli
Study officials:
affiliation: Fondazione Policlinico A. Gemelli
name: Antonio M Dell'Anna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196962: Safety Study of Subclavian and Internal Jugular Venous Catheterization
Official title: A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time to Insertion
Rates of Complications
Keywords: central venous catheter
complications
internal jugular vein
randomized trial
subclavian vein
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. The aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. An improved understanding of CVC-related risks might help clinicians to choose one approach over the other in specific clinical settings.

Detailed description: Central venous catheterization is often necessary to treat critically ill patients hospitalized in intensive care units (ICUs). However, this procedure may lead to serious and sometimes life-threatening complications, including mechanical, infectious, or thrombotic complications. The choice of insertion site can influence the incidence and type of such complications. The most frequently used sites for CVC insertion are the internal jugular and the subclavian vein. However, in an individual patient, criteria for choosing one approach over the other remain unclear.

Eligibility criteria: Inclusion Criteria:

* admission to ICU
* requiring central venous catheterization
* without contraindications to attempt both jugular and internal jugular access

Exclusion Criteria:

* the presence of a central venous catheter at admission
* central venous catheterization within 2 weeks prior to admission
* emergency catheterization for a life-threatening situation
* major blood coagulation disorders
* anatomic defect precluding catheterization at either site
* skin lesions or recent surgery at either site

Primary outcomes:
measure: Time to completely insertion
timeFrame: 1 hour
Secondary outcomes:
measure: rates of mechanical, infectious, and thrombotic complications
timeFrame: 14 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da hospital
Study officials:
affiliation: Chest department
name: Yu-Feng Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570762: Long Term Outcomes Of Hybrid Percutaneous Approach
Official title: Long Term Outcomes Of Hybrid Percutaneous Intervention With Bioresorbable Vascular Scaffolds And Drug Eluting Stents For Complex Coronary Artery Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: bioresorbable vascular scaffold
Lead sponsor: Liv Hospital Ankara
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiology clinic

Brief summary: Bioresorbable vascular scaffolds (BVS) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up. However, current generation BVS have also some drawbacks that restrict the use for complex lesions. Using BVS and drug eluting stents (DES) together -implanting DES for BVS inappropriate segments -may be a feasible option to avoid the disadvantages of permanent foreign body and to reduce very late adverse events. In this context, we investigated the clinical outcomes following treatment with hybrid strategy with concomitant use of BVS and DES for complex lesions. A single center retrospective cohort was performed enrolling 40 patients with complex lesions treated with hybrid approach from February 2015 up to April 2017. Lesion segments with a large plaque burden and/or severe calcification, aorto-ostial and bifurcation lesions that may be unfavorable for BVS, treated with DES. BVS and DES were implanted with minimal overlap of DES and BVS struts. The primary end-point was target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization (TLR). During follow-up, coronary angiography was performed when patients had ischemic symptoms.


Eligibility criteria: Inclusion Criteria:

* treated with BVS in combination with DES

Exclusion Criteria:

* treated with only DES or BVS

Primary outcomes:
measure: target lesion failure
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05161962: Oral Care to Prevent Ventilator-associated Pneumonia
Official title: Investigation of the Effect of Oral Care Given by Two Different Methods in Patients Connected to Mechanical Ventilators on the Development of Ventilator-AssociatedPneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene, Oral Health
Ventilators, Mechanical
Keywords: Mechanical ventilation
nursing
oral care
pneumonia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

Detailed description: The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.

Eligibility criteria: Inclusion Criteria:• Patients on mechanical ventilator who have been in intensive care for at least 48 hours

* Male and female patients over the age of 18
* Patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis
* Patients whose respiratory support is provided by a mechanical ventilator
* Patients who are considered to be able to provide mechanical ventilator support for 7 days
* Patients without any respiratory-related infectious pathogens
* Obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent.
* It was determined as patients who did not undergo any intraoral surgical intervention.

Exclusion Criteria: patients with pneumonia Patients younger than 18 years

-

Primary outcomes:
measure: oral care application with standard oral care stick
timeFrame: 1 in 6 hours
measure: Oral care application with a sucking oral care stick
timeFrame: 1 in 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
References:
Clinical trial NCT00123162: Viagra in the Treatment of Primary Dysmenorrhea
Official title: Sildenafil Citrate in the Treatment of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dysmenorrhea
Keywords: Sildenafil
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-07-22
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.

Detailed description: It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.

Eligibility criteria: Inclusion Criteria:

* Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of \>35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.

Exclusion Criteria:

* Secondary dysmenorrhea
* Any current medication
* Serious medical condition

Primary outcomes:
measure: The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.
timeFrame: Hours 1, 2, 3 and 4.
Secondary outcomes:
measure: Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
timeFrame: Each hour of the study (0, 1, 2, 3, 4).
Other outcomes:
Locations:
city: Strossmayerova 17
country: Croatia
facility: Nova Gradiska General Hospital
state: Zagreb
Study officials:
affiliation: Penn State University College of Medicine
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.
Clinical trial NCT02305862: A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques
Official title: An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and Hyperlipideimia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriosclerosis
Diabetes Mellitus
Lipid Disorder
Keywords: Coronary Arteriosclerosis
Carotid Atherosclerotic Plaque
Rosuvastatin
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 150
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: TREATMENT

Brief summary: The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).

Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.


Eligibility criteria: Inclusion Criteria:

-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction

Exclusion Criteria:

* Planning coronary stenting
* Heart failure
* Uncontrolled hypertension（≥200/110mmHg)
* Uncontrolled diabetes mellitus (HbA1C≥9.5%)
* Hepatic insufficiency
* Renal dysfunction
* Cancer

Primary outcomes:
measure: To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI
timeFrame: 26 weeks
Secondary outcomes:
measure: major adverse cardiovascular events
timeFrame: 26 weeks
measure: To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
timeFrame: 26 weeks
measure: To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks
timeFrame: 26 weeks
measure: To evaluate the change from baseline in renal function (serum creatine) at 26 weeks
timeFrame: 26 weeks
measure: To evaluate the change from baseline in creatine kinase at 26 weeks
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT05238662: Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage
Official title: A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.

● Alternative hypothesis (H1):

Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.

Detailed description: Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation.

Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues.

Sample size:

The Study will include 40 patients divided into two groups, each group containing 20 patients.

Eligibility criteria: Inclusion Criteria:

* Patient acceptance.
* Both sexes.
* Age (21-60) years old.
* Patients with monosegmental lumber degenerative spinal diseases including lumbar spondylosis, spondylolysis, spondylolisthesis grade one, or lumbar disc prolapse.

Exclusion Criteria:

* Patient refusal.
* Altered mental status.
* Patients with associated comorbidity interfere with surgery.
* Extremes of age.
* Multiple level lumbar degenerative disease
* Trauma
* Spinal tumour
* Active infection
* Previous lumbar operation

Primary outcomes:
measure: Evaluation of fusion status
timeFrame: up to 3 months
Secondary outcomes:
measure: Back Pain
timeFrame: At 24 hours, 2 weeks and 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Zagazig University, Faculty of human medicine
name: Wael Elmesallamy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836862: Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
Official title: Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Keywords: Hemodialysis
Vascular access
Arteriovenous fistula
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be eligible if they are 19 years of age or greater and have placement of an arteriovenous fistula planned witin 30 days.

Brief summary: This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Detailed description: Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Eligibility criteria: Inclusion Criteria:

* Age 19 years of age or greater
* Arteriovenous fistula placement for hemodialysis access scheduled within 30 days

Exclusion Criteria:

* Incompetent to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Troy J Plumb, MD
role: PRINCIPAL_INVESTIGATOR
References: