louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03885752: The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Official title: The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Sore Throat
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively can reduce the incidence of POST after general anaesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA).


Eligibility criteria: Inclusion Criteria:

American Society of Anaesthesiologists (ASA) class I or II 20-65 years body mass index (BMI) scores \<30 undergoing elective hysteroscopic surgery -

Exclusion Criteria:

chronic laryngitis chronic bronchitis asthma gastroesophageal reflux allergies to study drugs recent use of non-steroidal anti-inflammatory drugs (NSAIDs) a history of upper respiratory tract infection in the past one week Mallampati grade\>2 a history of steroid therapy.

-

Primary outcomes:
measure: the incidence of POST scores > 3
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: the POST scores
timeFrame: 2 hours, 6 hours and 24 hours after surgery.
Other outcomes:
measure: subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
timeFrame: Immediately after removal of laryngeal mask
Locations:
city: Shanghai
country: China
facility: Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Study officials:
References:
citation: Wang T, Wang Q, Zhou H, Huang S. Effects of Preoperative Gum Chewing on Sore Throat After General Anesthesia With a Supraglottic Airway Device: A Randomized Controlled Trial. Anesth Analg. 2020 Dec;131(6):1864-1871. doi: 10.1213/ANE.0000000000004664.
Clinical trial NCT01049152: Continuous Glucose Monitoring and Inflammation in Nondiabetic and Diabetic Patients Undergone Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
End Stage Renal Disease
Keywords: Diabetes mellitus
ESRD
CGM
Inflammation markers
Hemodialysis
Diabetic patients
Nondiabetic patients
All with ESRD
All undergone hemodialysis
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients will undergo CGM at two different hemodialysis methods in a croos-over design. At the end of the study, it will evaluate inflammation markers intra-and inter-groups during the different hemodialysis methods.

Brief summary: Evaluation of different glycemic variations between the dialysis period and non-dialysis period in two groups: nondiabetic and diabetic patients undergone two different hemodialysis methods. Thirty-six patients, males and females, aged 50-80 years, with end stage renal disease (ESRD) will undergo hemodialysis and continuous glucose monitoring (CGM). The investigators will evaluate also inflammation markers before and after the different hemodialysis methods.


Eligibility criteria: Inclusion Criteria:

* patients with or without diabetes mellitus
* ESRD
* undergone hemodialysis
* males and females aged 50-80

Exclusion Criteria:

* tumors
* chronic inflammation diseases
* AMI
* acute pulmonary diseases

Primary outcomes:
measure: -Hemodialysis tolerability -Hypoglycemia numbers -Hyperglycemia numbers -Inflammation markers
timeFrame: before and after each procedure
Secondary outcomes:
measure: variations of glycemia during the night; insulin-sensitivity
timeFrame: at the beginning of the first hemodialysis and at the end of the second hemodialysis
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: University of Pavia- Fondazione IRCCS Policlinico San Matteo
name: Giuseppe Derosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derosa G, Libetta C, Esposito P, Borettaz I, Tinelli C, D'angelo A, Maffioli P. Effects of two different dialytic treatments on inflammatory markers in people with end-stage renal disease with and without type 2 diabetes mellitus. Cytokine. 2017 Apr;92:75-79. doi: 10.1016/j.cyto.2016.12.026. Epub 2017 Jan 18.
citation: Derosa G, Libetta C, Esposito P, Borettaz I, Tinelli C, D'Angelo A, Maffioli P. Bicarbonate dialysis compared to hemodiafiltration on glycemic excursions in patients with end-stage renal disease with and without type 2 diabetes mellitus. J Diabetes Complications. 2015 Nov-Dec;29(8):1136-41. doi: 10.1016/j.jdiacomp.2015.08.009. Epub 2015 Aug 13.
Clinical trial NCT01761552: A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients
Official title: A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: in ASA 4 AND ASA 4E patients
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 130
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: To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients

Primary endpoint:

• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.

Secondary endpoints:

• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)


Eligibility criteria: Inclusion Criteria:

* ASA 4 AND ASA 4E patients
* Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -

Exclusion Criteria:

* Patients ASA 1-3 or 5
* Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
* Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
* Hypersensitivity to the active substances or to any of the excipients of medications used
* Patients with severe renal impairment (including patients requiring dialysis (CrCl \< 30mL/min))
* Patients with severe hepatic impairment
* Age \< 18 years

Primary outcomes:
measure: Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
timeFrame: 24 hours
Secondary outcomes:
measure: Time to extubation - measure the difference in time from application of the surgical dressing until extubation.
timeFrame: 24 hours
measure: Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
timeFrame: 24 hours
Other outcomes:
measure: The effect of Sugammadex on cortisol levels
timeFrame: 72 hours
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoram G Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231152: The Impact of Obesity on Children and Adolescents.
Official title: The Relation of Obesity With Metabolic Disorders, Inflammation Markers and Arterial Blood Pressure With Preclinical Target-organ Damage in Children and Young Adolescents.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Cardiovascular Risk Factors
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents referred for increased body weight.

Brief summary: The aim of the study is to investigate the association of obesity with arterial blood pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin resistance in children and young adolescents.


Eligibility criteria: Inclusion Criteria:

* Overweight (85th\<BMI\<95th percentile) and obese (BMI\>=95th percentile) children and adolescents
* No medication treatment (apart from bronchodilators, T4 in euthyroid children)
* No severe mental problem
* Parents' and patients' signed consent

Exclusion Criteria:

* Severe chronic or acute cardiac disease or other severe chronic or acute disease
* Any acute inflammation
* Familial dyslipidemia
* Clinical hypothyroidism or other endocrinopathy
* Poor compliance.

Primary outcomes:
measure: Blood Pressure levels, Target organ damage (Left Ventricular Hypertrophy, IMT, pulse wave velocity, microalbuminuria), Insulin Resistance
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens
Study officials:
affiliation: University of Athens
name: George S Stergiou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200252: Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
Official title: Intramuscular Versus Intravascular Oxytocin for the Third Stage of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Stage of Labour
Keywords: oxytocin
third stage
dose
route
blood loss
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mothers are given the medication oxytocin after birth to help the uterus (womb) contract and therefore reduce blood loss. In Canada, oxytocin is given either into the muscle of the thigh or into a vein. However, it is not known which route is better.This study will test which dose and route of oxytocin is best in reducing blood loss following vaginal delivery.


Eligibility criteria: Inclusion Criteria:

* women 19 years and older
* singleton pregnancy
* 32 weeks gestation
* spontaneous vaginal delivery

Exclusion Criteria:

* previous postpartum hemorrhage
* placenta previa
* grand multiparity (\>4)
* anticoagulation therapy
* delivery prior to 32 weeks gestation
* operative vaginal delivery
* antepartum hemorrhage \> 20 weeks
* hemoglobin \<10g/dL
* multiple gestation
* intrauterine death

Primary outcomes:
measure: change in hematocrit
Secondary outcomes:
measure: estimated blood loss
measure: postpartum hemorrhage (estimated blood loss > 500cc)
measure: severe postpartum hemorrhage (estimated blood loss > 1000cc)
measure: incidence of hypotension
measure: length of third stage of labour
measure: need for blood transfusion
measure: incidence of retained placenta
measure: need for dilatation and curettage
measure: need for hysterectomy
measure: need for additional oxytocics after delivery
measure: postpartum antibiotic use
measure: maternal satisfaction
measure: bleeding needing readmission
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Women's Health Centre, Eastern Health
state: Newfoundland and Labrador
Study officials:
affiliation: Resident, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
name: Colleen L Cook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty, Discipline Obstetrics and Gynecolgy, Memorial University of Newfoundland
name: Joan Crane, MD
role: STUDY_DIRECTOR
References:
citation: Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
Clinical trial NCT00107952: Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Pneumonia
Keywords: Nosocomial pneumonia
MRSA
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-04-12
Enrollment: 761
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: Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

* Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization

Primary outcomes:
measure: Clinical Response
timeFrame: 7 - 14 days following end of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Duke University
name: G. Ralph Corey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
citation: Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.
citation: Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.
Clinical trial NCT03217552: The Performance of the Mologic Biomarker Panel in Infection
Official title: An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Infection
Lead sponsor: Mologic Ltd
Sponsor class: INDUSTRY
Collaborators: name: University College London Hospitals
name: Innovate UK
First posted: 2017-07-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe infection from:

* The Emergency Department
* Critical Care Unit
* Patients undergoing major surgery

Brief summary: This study is a prospective, single center, observational, cohort study of patients to determine whether the Mologic Biomarker Panel can identify patients with infection from those without, including those with other reasons for inflammation (e.g. post-operative). It will also assess whether it has the potential to judge the severity of illness, prognosticate outcome and guide antibiotic therapy.

The aim is to recruit patients who are "representative" of patients with suspected sepsis, uncomplicated infection, or non-infection related critical illness that require critical care intervention and assessment.

This study is observational and will not alter patient management or the standard of care. The results from the investigational Mologic Biomarker Panel and associated research assays will not be provided to treating clinicians, or used in any manner to affect patient care.

The study will take place over approximately an 18-month period and it is anticipated that approximately 600 patients will be collectively enrolled. The study aims to recruit patients from three environments within UCLH:

* The Emergency Department.
* Critical Care Unit
* Patients undergoing major surgery


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Investigated for potential infection (the clinical need for a blood culture)

Exclusion Criteria:

* \<18 years old
* Severe anaemia (\<60g/dl) and contra-indication to transfusion
* Unable to gain consent or agreement
* Treated with palliative intent
* Blood culture indicated for screening or monitoring

Primary outcomes:
measure: Biomarkers and results from routine clinical testing for infection
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College London Hospital
name: David Brealey, PhD MRCP FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06779552: CardioMEMS HF System Coverage with Evidence Development Study
Official title: CardioMEMS HF System Coverage with Evidence Development Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.

Brief summary: The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

Detailed description: The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Eligibility criteria: Inclusion Criteria:

1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
2. Subject \>=18 years of age at time of implant
3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP

Exclusion Criteria:

1. Subject has history of heart transplant or durable mechanical circulatory device
2. Subject hospitalized with cardiogenic shock or sepsis
3. Subject received prior PA pressure sensor implant (control arm only)

Primary outcomes:
measure: HF Hospitalization Rate.
timeFrame: 2 years
Secondary outcomes:
measure: Two-Year Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Abbott
state: California
Study officials:
References:
Clinical trial NCT01037452: Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heartburn
Keywords: Heartburn
antacid
PPI
Lansoprazole
calcium carbonate
magnesium hydroxide
Relief of heartburn following ingestion of a heartburn-inducing meal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.


Eligibility criteria: Inclusion Criteria:

* Experiencing heartburn in the past month if untreated
* Having heartburn that responds to heartburn medication
* Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

* Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
* Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"

Primary outcomes:
measure: Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
timeFrame: 1 day
Secondary outcomes:
measure: Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
timeFrame: 1 day
measure: Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
timeFrame: 1 day
measure: Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
timeFrame: 1 day
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
Study officials:
affiliation: Novartis
name: Novartis .
role: STUDY_DIRECTOR
References: