louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03302208: Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia
Official title: Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hysterectomy
Keywords: General Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) may be effective in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60 years, schedule for elective abdominal hysterectomy surgery under general anesthesia.

Detailed description: In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) would be effective in reducing intraoperative isoflurane requirement needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for elective abdominal hysterectomy surgery under general anaesthesia.

The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements) in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Female patients, aged 18-60 year scheduled for elective abdominal hysterectomy surgery under general anaesthesia.
* American Society of Anaesthesiology (ASA) physical status I or II.

Exclusion Criteria:

* American Society of Anaesthesiology (ASA) physical status ≥ III.
* Allergy or hypersensitivity to pregabalin.
* Patient on calcium channel blocker or anticonvulsant.

Primary outcomes:
measure: Inhalational anaesthetic drug requirements
timeFrame: an average of 3 hours after induction
Secondary outcomes:
measure: pressor response attenuation
timeFrame: an average of 10 minutes after induction
measure: First time for analgesics requirement
timeFrame: postoperative (maximum 6 hours after the end of operation)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Zamalek
Study officials:
References:
Clinical trial NCT04028908: Remodelling After Trampoline Fracture in Children
Official title: Remodelling After Trampoline Fracture in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trampoline Fracture
Tibial Fracture
Keywords: ventral tilting of the tibial plateau
anterior tilt angle
proximal tibia epiphyseal plate
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
Collaborators: name: Medical Research Council Kantonsspital Aarau, Switzerland
First posted: 2019-07-23
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children between 2-5 years of life with the diagnosis of a trampoline fracture in the radiographs of the tibia in two views at the Kantonsspital Aarau, Universitätsspital Bern, Universitätskinderspital Zürich, UKBB Universitätsspital Basel, Kantonalspital Luzern.

Brief summary: The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.


Eligibility criteria: Inclusion Criteria:

* trampoline fracture of the proximal lower leg

Exclusion Criteria:

* proximal tibial fractures with unclear etiology

Primary outcomes:
measure: anterior tilt angle of the tibia
timeFrame: one year after fracture
Secondary outcomes:
measure: difference of anterior tilt angle of the fractured tibia compared with the angle of the healthy tibia
timeFrame: one year after fracture
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Bern
country: Switzerland
facility: Universitätsspital Bern
Study officials:
affiliation: Kantonsspital Aarau
name: Peter Klimek, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06769308: Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients
Official title: Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedation Complication
Mechanical Ventilation Complication
Keywords: ICU, sedation, analgesia, mechanical ventilation
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: Arcispedale S. Anna, Ferrara
First posted: 2025-01-10
Enrollment: 174
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: PREVENTION

Brief summary: Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs.

The present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.


Eligibility criteria: Inclusion Criteria:

Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \>48 hours Ongoing sedation

Exclusion Criteria:

Mechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes

Primary outcomes:
measure: Ventilator free days
timeFrame: Day 28
Secondary outcomes:
measure: Delirium occurrence
timeFrame: Daily after extubation
measure: ICU lenght of stay
timeFrame: ICU discharge
measure: Drug consumption
timeFrame: ICU discharge
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Sant'Anna
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II - "Policlinico"
Study officials:
References:
Clinical trial NCT02897908: Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
Official title: Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disease of Liver and Bile Duct
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Kaleida Health
First posted: 2016-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
* Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
* Subjects who have other known liver diseases ie: hepatitis C virus (HCV)

Brief summary: The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

Detailed description: The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Eligibility criteria: Inclusion Criteria:

* Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
* Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
* Subjects who have other known liver diseases ie: HCV

Exclusion Criteria:

* Patients less than 18 years of age
* Pregnancy
* Patients that do not want to be contacted for consideration in future research studies.
* Patients diagnosed with ascites or peritoneal dialysis
* Body mass index (BMI) ≥40

Primary outcomes:
measure: measurement of fibrosis in patients with varying degrees of liver disease
timeFrame: 10 years
Secondary outcomes:
measure: measurement of liver fat in patients with varying degrees of liver disease
timeFrame: 10 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Conventus Medical Office Building
state: New York
Study officials:
References:
Clinical trial NCT02072408: Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polypoidal Choroidal Vasculopathy Without Active Polyp
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Kim's Eye Hospital
name: Bayer
First posted: 2014-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.


Eligibility criteria: Inclusion Criteria:

* polypoidal choroidal vasculopathy without active polyp
* decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

Exclusion Criteria:

* polypoidal choroidal vasculopathy with active polyp
* previous photodynamic therapy more than three times
* anti-VEGF injection within one month
* photodynamic therapy or intraocular steroid treatment within three months

Primary outcomes:
measure: Change of best-corrected visual acuity (ETDRS letters)
timeFrame: 1 year
Secondary outcomes:
measure: presence of subretinal hemorrhage
timeFrame: during 1 year
measure: presence of fluid in macula evidenced by optical coherence tomography
timeFrame: during 1 year
measure: change of indocyanine green angiography
timeFrame: during 1 year
measure: Number of eyes which need rescue treatment (photodynamic therapy)
timeFrame: during 1 year
measure: safety outcomes
timeFrame: one year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
city: Seoul
country: Korea, Republic of
facility: Konyang University Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01185808: Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Official title: Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Sinusitis
Keywords: sinusitis
chronic sinusitis with polyps
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
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 Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

Detailed description: Introductory Statement: Our laboratory has found that patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have insufficient levels of vitamin D3. This is a proposal to conduct a placebo controlled trial on the use of vitamin D3 (5,000IU/day for 6 weeks) to determine clinical and immunologic outcomes in these patients.

General Investigational Plan: We routinely examine vitamin D levels in all patients with CRSwNP. Those that are insufficient (less than 32 ng/ml) and have agreed to undergo sinus surgery will be randomized to placebo or vitamin D3 supplementation (5,000IU/day) for 6 weeks prior to surgery. Blood will be drawn pre- and post-supplementation to examine systemic immune parameters such as dendritic cell and T cell expression and cytokine levels. Sinus tissue will be collected at the time of surgery to analyze local immune parameters (dendritic cell, T cell and cytokine levels) between supplemented and placebo groups. Clinical outcomes will be analyzed using quality of life questionnaires, endoscopic grading and nasal peak inspiratory flow pre- and post- supplementation. IRB approval for this research project is pending.

Eligibility criteria: Inclusion Criteria:

* Chronic sinusitis with polyps

Exclusion Criteria:

* Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)
* Pregnancy or age less than 14 years.

Primary outcomes:
measure: Clinical symptom score
timeFrame: 6 weeks
Secondary outcomes:
measure: Nasal peak inspiratory flow
timeFrame: 6 weeks
measure: Systemic and local immunologic parameters
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Rodney Schlosser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790308: Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
Official title: Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 100
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: The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Detailed description: The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.liraglutide combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed type 2 diabetes
* fasting blood glucose (FBG) level ranging from 7.0-16.7mmol/L
* body mass index (BMI) ranging from 21-35kg/m2
* antihypercaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

* having any severe acute or chronic diabetic complications
* renal dysfunction, blood creatinine\>150umol/L
* blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
* any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
* chronic or acute pancreatic disease
* severe systemic diseases or malignant tumor
* female patients incline to be pregnant
* being treated with corticosteriod, immunosuppressing drugs or cytotoxic drugs
* poor compliance

Primary outcomes:
measure: the percentage of the patients who maintain glucose control 1 year after short intensive therapy
timeFrame: 1 year
Secondary outcomes:
measure: the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients
timeFrame: 1 year
measure: the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Education
name: Yanbing Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767208: Diabetes and Metabolic Postprandial Responses
Official title: Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Overweight
Keywords: type 2 diabetic subjects
Lead sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe
Sponsor class: OTHER
Collaborators: name: LESAFFRE SA
First posted: 2008-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese volunteers
* Healthy for one group nd type 2 diabetic for the second group
* Age between 30 and 65 years old
* Total cholesterol \< or = 7 mmol/l and triglycerides \< or = 4 mmol/l
* For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c \< 6%
* Stable weight over last 3 months
* Informed consent

Exclusion Criteria:

* No compliant subjects
* Participation in an other trial 2 months before starting this one
* Ward of court or under guardianship (sheltered adults)
* Person deprived of freedom by judicial or administrative decision
* Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose
* Existence of a previously diagnosed pathology (other than type 2 diabetes)
* Previous gastro-intestinal pathology
* Treated by corticoids, anorexigens, weight loss medicines
* Alcoholism or severe tobacco consumption

Primary outcomes:
measure: Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism
timeFrame: 6 hours postprandially
Secondary outcomes:
measure: Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides
timeFrame: 6 hours postprandially
measure: Carbohydrate and lipid oxidation
timeFrame: 6 hours postprandially
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Recherche En Nutrition Humaine Rhone Alpes
Study officials:
References:
Clinical trial NCT03485508: The Brugada Syndrome: a Follow-up Study
Official title: Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brugada Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.

Brief summary: Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosis of Brugada syndrome

Exclusion Criteria:

* history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy

Primary outcomes:
measure: Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation
timeFrame: 6 years
Secondary outcomes:
measure: Syncope
timeFrame: 6 years
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References: