louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01024075: Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes
Official title: The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Rhinosinusitis
Keywords: Chronic Rhinosinusitis
Endoscopic sinus surgery
Sinufoam
Dexamethasone
For patients with Chronic Rhinosinusitis without nasal polyps
Focus: Define the postoperative sinonasal mucosal healing status of 2 Sinufoam mixtures
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 40
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: Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing.

Detailed description: Sinufoam is an FDA approved mixture, which is placed in the ethmoid cavity at the completion of an endoscopic sinus surgery procedure. Sinufoam prevents scarring and promotes healing of the sinonasal mucosa. Sinufoam is commonly mixed with saline, which enables it to be liquefied and gently placed into the ethmoid cavity. Recent practice of adding Dexamethasone to the sinufoam mixture has been hypothesized to promote healing by reducing chronic inflammation associated with CRS. Using topical dexamethasone mixed into the Sinufoam solution may improve patient care by preventing the systemic effects associated with post-operative systemic steroid use.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* Chronic Rhinosinusitis without nasal polyps --- defined according to the AAO guidelines
* Elective "Bilateral" sinus surgery requiring at a minimum of an Uncinectomy, Maxillary Antrostomy, and Anterior Ethmoidectomy.

Exclusion Criteria:

* Uncorrectable coagulopathy
* Emergency procedure
* Unavailable for standard post operative follow-up
* Sinonasal neoplasm resections
* Excessive intra-operative bleeding requiring nasal packing

Primary outcomes:
measure: Sinonasal mucosal healing
timeFrame: 1 month
Secondary outcomes:
measure: Sinonasal quality of life (SNOT-22)
timeFrame: 1 month
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Luke Rudmik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-Foam middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. 2012 May-Jun;2(3):248-51. doi: 10.1002/alr.21011. Epub 2012 Jan 17.
Clinical trial NCT05861375: Liver Biomarkers in Anorexia Nervosa
Official title: Assessment of Liver Damage Using the Fibroscan in Patients With Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: Liver Fibrosis
Liver Steatosis
Enteral Refeeding
Anorexia Nervosa
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.

Brief summary: The main goal of the Liver Biomarkers in Anorexia Nervosa (LIBAN) study is to determine the prevalence of liver fibrosis in patient with Anorexia Nervosa.

Detailed description: Prevalence of hepatic fibrosis will be non-invasively investigated, in the Anorexia Nervosa inpatient population, using the Fibroscan ®. Furthermore, liver blood markers will be assessed.

Eligibility criteria: Inclusion Criteria :

* Patient over 15 years old
* Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Admission to the endocrinology, diabetology and nutrition department of the Nantes University Hospital.

Exclusion Criteria :

* Chronic active viral hepatitis
* Hemochromatosis
* Other genetic, autoimmune, toxic or drug-induced hepatitis
* Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
* Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)

Primary outcomes:
measure: Liver fibrosis prevalence in patients with Anorexia nervosa
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Sarra SMATI-GRANGEON, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02261675: Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children
Official title: Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Keywords: dexmedetomidine
sevoflurane
MAC bar
drug interaction
anesthesia
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 63
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.

Detailed description: The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* aged 2 to 6 yr
* American Society of anesthesiologists I or II
* scheduled to have general anesthesia and to have skin incisions on the abdomen

Exclusion Criteria:

* anemia or abnormal preoperative electrolyte concentrations
* a history of cardiovascular or central nervous system diseases
* a history of pulmonary disease
* known hepatic or renal disease
* a body weight exceeding 50% of the upper limit of ideal body weight for height
* taking drugs with cardiovascular or central nervous system effects
* use of any experimental drug within the past 30 days
* allergy to any drug that may be administered during the study
* exposure to general anesthesia within the previous 7 days
* second- or third-degree atrioventricular block
* taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids or sedatives)

Primary outcomes:
measure: the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
timeFrame: at once before incision and 5 min period after incision
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
name: Xuan Ke Liu, Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.
Clinical trial NCT04662970: Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology
Official title: Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Detailed description: Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations.

After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.

Eligibility criteria: Inclusion Criteria:

* patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software
* left bundle branch block before CRT implantation
* PQ interval ≤ 250 ms before implantation

Exclusion Criteria:

* high-grade AV block
* any contraindication concerning a safe CMR performance including claustrophobia
* terminal heart failure (NYHA IV) or cardiac decompensation
* life expectancy \< 1 year
* women with child-bearing potential, pregnancy
* drug abusus

Primary outcomes:
measure: Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation
timeFrame: The measurements will be done at Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Wolfgang Dichtl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04057170: Manual Therapy Versus Conventional Rehabilitation Protocol on Subacromial Pain Syndrome
Official title: Comparison of the Effects of Mulligan Mobilization With Movement Method and Accelerated Rehabilitation Protocol on Shoulder Pain and Functions in Subacromial Pain Syndrome: A Randomized Single Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: shoulder pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the periodic effects of Accelerated rehabilitation protocol (ARP) and Mulligan mobilization with mowement method (MWM) in subacromial pain syndrome patients rehabilitation. Half of the participants will receive ARP, while the other half will receive MWM.


Eligibility criteria: Inclusion Criteria:

* to be in the 18-60 age range, to be cooperative during evaluation and treatment and to accept to participate in the study

Exclusion Criteria:

* the presence of adhesive capsulitis, surgical indication or shoulder surgery, cervicothoracic problems (such as stenosis and disc herniation) diagnosed as neurological or inflammatory joint diseases

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: two weeks
measure: Visual Analogue Scale
timeFrame: two weeks
measure: Active Range of Motion measurement
timeFrame: two weeks
measure: Subacromial Interval Measurement
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Volkan Deniz
Study officials:
References:
Clinical trial NCT00046670: Sleep Disordered Breathing, APOE, and Lipid Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Lung Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2002-10-01
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the relationship between obstructive sleep apnea and lipid metabolism.

Detailed description: BACKGROUND:

Recent findings suggest interrelationships between obstructive sleep apnea, lipid metabolism, and neurodegeneration. Apolipoprotein E epsilon4 (APOE e4), a genetic marker linked to increased cardiovascular disease (CVD) risk and Alzheimer's disease (AD), is associated with a two fold increased risk of sleep disordered breathing (SDB), and an increase in severity of apnea symptoms. Preliminary data suggest that this association is stronger between the ages of 50 and 65. Other experiments suggest dysregulated leptin levels in obstructive sleep apnea (OSA). Taken together, these findings suggest common pathophysiological mechanisms involving dysregulated lipid metabolism in OSA. An understanding of these mechanisms is essential for the prevention and treatment of SDB.

DESIGN NARRATIVE:

Using case/control and family designs, the study: 1) extends the finding that apolipoprotein E epsilon4 (APOE e4) increases the risk of sleep apnea in the general population; 2) examines if polymorphisms in other genes regulating lipid levels are associated with sleep apnea; 3) studies the relationship between lipid regulatory gene polymorphisms, lipid profile (LDL- cholesterol, HDL-cholesterol, triglycerides), plasma leptin (and other lipid regulatory hormones), and sleep apnea levels.

T

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Emmanuel Mignot
References:
citation: Lin L, Finn L, Zhang J, Young T, Mignot E. Angiotensin-converting enzyme, sleep-disordered breathing, and hypertension. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1349-53. doi: 10.1164/rccm.200405-616OC. Epub 2004 Sep 24.
citation: Gottlieb DJ, DeStefano AL, Foley DJ, Mignot E, Redline S, Givelber RJ, Young T. APOE epsilon4 is associated with obstructive sleep apnea/hypopnea: the Sleep Heart Health Study. Neurology. 2004 Aug 24;63(4):664-8. doi: 10.1212/01.wnl.0000134671.99649.32.
citation: Taheri S, Lin L, Austin D, Young T, Mignot E. Short sleep duration is associated with reduced leptin, elevated ghrelin, and increased body mass index. PLoS Med. 2004 Dec;1(3):e62. doi: 10.1371/journal.pmed.0010062. Epub 2004 Dec 7.
Clinical trial NCT02031770: Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease
Official title: Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Acidosis
Chronic Kidney Disease
Keywords: vascular endothelial cells
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
First posted: 2014-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.


Eligibility criteria: Inclusion Criteria

* Age 40-70 years
* CKD stage IV (eGFR 15-29 ml/min/1.73m2; stable renal function in the past 3 months)
* Serum bicarbonate level of \< 20 and ≥ 16 meq/L (at least 2 consecutive weekly measurements)
* Body mass index \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
* Ability to give informed consent
* Stable anti-hypertensive, diabetic and lipid lowering regimen for at least one month prior to randomization

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Expected to undergo living related kidney transplant in next 6 months
* Expected to start dialysis in next 3 months
* Overt congestive heart failure
* Use of sevelamer
* Use of calcium carbonate

Primary outcomes:
measure: Change in Brachial Artery Flow Mediated Dilation (FMD)
timeFrame: 6 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353170: Calcium Concentration in Bicarbonate Hemodialysis (HD)
Official title: Comparison Among Different Dialysate Calcium Concentrations in Bicarbonate Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcium Mass Balances and Serum Calcium Profiling in hd Patients
Keywords: Serum calcium
Dialysate
Mass balance
Blood pressure
Lead sponsor: Miulli General Hospital
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed in order to investigate the effects of 3 different dialysate calcium concentrations may exert on mineral metabolism and hemodynamic stability in standard hemodialysis (hd).


Eligibility criteria: Inclusion Criteria:

* bicarbonate hd since 6 months
* uncomplicated hd sessions

Exclusion Criteria:

* Incident patients
* unstable hd patients
* patients aged less than 18 years

Primary outcomes:
measure: Serum calcium concentrations
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Nephrology and dialysis unit Miulli General Hospital
state: Bari
Study officials:
References:
Clinical trial NCT06789770: Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep
Official title: The Impact of Nasal Versus Oral Breathing on Measures of Drug-Induced Sleep Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: breathing route
OSA
nasal breathing
oral breathing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: McCabe Fund
First posted: 2025-01-23
Enrollment: 50
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: People who are referred to the PI's CPAP alternatives clinic. They are of all ages (18+) and all genders.

Brief summary: This project will provide important new information regarding (1) the relationship between route of breathing and airway collapsibility and (2) whether route of breathing during DISE (Drug-Induced Sleep Endoscopy) is representative of natural sleep.

Detailed description: As part of standard of care, a drug-induced sleep endoscopy will be done, where route of breathing will be determined as a percentage of total breaths (during baseline, lateral sleep and maneuver). As part of the research procedure, an in-laboratory Polysomnogram will be conducted as study procedure including a oronasal pressure signal cannula to assess route of breathing.

Eligibility criteria: Inclusion Criteria:

* • Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology.

  * Must have at least mild OSA (AHI\>5)

Exclusion Criteria:

* • Sleep study with an AHI\<5, \>25% of total events being central or mixed events, or inability to achieve adequate drug-induced sleep.

  * Upper Respiratory Illness at the time of the DISE.

Primary outcomes:
measure: Is someone a mouth or nose breather? What kind of airway obstruction and collapse do they have?
timeFrame: During the DISE (30 minutes)
Secondary outcomes:
measure: Is a patients route of breathing the same during DISE and PSG?
timeFrame: During DISE (30 minutes) and PSG (1 night sleep study)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Julianna Rodin, MD
role: PRINCIPAL_INVESTIGATOR
References: