louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03309280: Influence of Different Parameters on Extubation Time After Cardiac Surgery.
Official title: Influence of Different Parameters on Extubation Time After Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for cardiac surgery in the Saint-Luc Bouge hospital.

Brief summary: The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery.

Detailed description: The aim of this study is to determine which factors could be at risk of delayed extubation after cardiac surgery. Several parameters of ventilation and infusion were recorded during surgery. A statistical analysis will be performed to determine if one of many of these are significant. The investigator does not assign specific interventions to the study participants, so the present study is observational and not interventional.

Eligibility criteria: Inclusion Criteria:

* All patients for elective cardiac surgery

Exclusion Criteria:

* Emergency procedures

Primary outcomes:
measure: Time of extubation
timeFrame: 2 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc de Bouge
state: Namur
Study officials:
affiliation: Astes
name: Eric Deflandre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170780: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Official title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inguinal Hernia
Femoral Hernia
Keywords: Inguinal hernia
Transabdominal preperitoneal hernia repair
TAPP
Dexamethasone
Pain
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.


Eligibility criteria: Inclusion Criteria:

* patients planned for elective laparoscopic hernia repair (TAPP)
* Unilateral inguinal or femoral hernia
* ASA class I-II
* Read and speak Danish

Exclusion Criteria:

* Acute hernia operation
* Operation for other hernias with mesh during the same procedure
* Endocrine disease (diabetes, adrenal insufficiency etc.)
* fever/infection within the first 10 days before operation
* Poor compliance
* No signed consent form
* Daily intake of opioids or anxiolytic drugs
* Manic episodes
* Use medicine against glaucoma
* Use thiazide or loop diuretics
* Vaccination within the last 14 days

Primary outcomes:
measure: pain during coughing
timeFrame: day 1
Secondary outcomes:
measure: pain during coughing
timeFrame: 4 days
measure: pain at rest
timeFrame: 4 days
measure: convalescence
timeFrame: 1 month
measure: pain at rest
timeFrame: 4 days
measure: nausea
timeFrame: 2 days
measure: vomiting
timeFrame: 2 days
measure: discomfort
timeFrame: 4 days
measure: fatigue
timeFrame: 4 days
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: University Hospital Koege
Study officials:
affiliation: University Hospital Koege
name: Mette A Tolver, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Koege
name: Thue Bisgaard, M.D. DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolver MA, Strandfelt P, Bryld EB, Rosenberg J, Bisgaard T. Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair. Br J Surg. 2012 Oct;99(10):1374-80. doi: 10.1002/bjs.8876.
Clinical trial NCT01905189: Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension
Official title: Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
cardiac resynchronization therapy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.

Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.


Eligibility criteria: Inclusion Criteria:

* Pulmonary hypertension type I, III, IV, V Dana Point classification
* NYHA classification equal or superior to stage II
* During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2
* Optimal therapy considered by the referring specialist practioner of the patient

Exclusion Criteria:

* Minor or incapacitated adult
* Pregnancy
* Unability to give free and informed consent
* Pulmonary hypertension type II Dana Point classification
* Eisenmenger syndrome
* Patent foramen ovale
* Left bundle-brach block
* Pulmonary hypertension exacerbation
* Medical clinical situation considered inappropriate by the investigator
* Patient eligible for a heart-lung transplant
* Patient eligible for pulmonary endarterectomy
* Patient with poor echogenicity
* Filter in the inferior vena cava

Primary outcomes:
measure: cardiac index measured during right catheterization
timeFrame: After two minutes of right stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen UH
state: Basse-Normandie
Study officials:
affiliation: Caen UH
name: Paul-Ursmar Milliez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494089: Analysis of the Stress Induced by in Situ Simulation
Official title: Analysis of the Stress Induced by in Situ Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychologic Stress
Heart Arrest
Keywords: in situ simulation
in hospital cardiac arrest
clinical audit
education
patient simulation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: team members

Brief summary: Vulnerability to psychologic distress induced by in situ simulation.

Objectives: Psychological evaluation at short and long term on working satisfaction, mental health, and acute stress after in situ simulation. Analysis of the stress vulnerability induced by simulation.

Design: non interventional study.

Primary outcome: Psychologic distress analysis with validated psychologic distress inventory (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale Revisited (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B (STAI-B)).


Eligibility criteria: Inclusion Criteria:

* team members: nurses, auxiliary nurse, residents, doctors, students

Exclusion Criteria:

* non volunteers

Primary outcomes:
measure: psychologic distress analysis induced by in situ simulation
timeFrame: 3 weeks
Secondary outcomes:
measure: Stress vulnerability to in situ simulation
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00845689: Prevention of Liver Damage During Liver Surgery
Official title: Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Tumors
Keywords: liver surgery
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2009-02-18
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.


Eligibility criteria: Inclusion Criteria:

* elective resection of liver tumors
* age 18 to 80 years
* informed consent

Exclusion Criteria:

* chronic obstructive pulmonary disease
* heart insufficiency NYHA III-IV
* atrio-ventricular conductance blockage II. (Mobitz) or III. degree
* atrial fibrillation
* coronary heart disease (CCS III. or IV. degree)
* arterial hypertension
* acute renal failure
* increased intracranial pressure
* gout
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04377789: Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Official title: The Possible Effect of Quercetin on Prophylaxis and Treatment of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Orbiteratec (funding)
First posted: 2020-05-06
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.

Detailed description: Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. Upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.

Eligibility criteria: Inclusion Criteria:

* moderate-high risk for COVID-19
* obtained informed consent

Exclusion Criteria:

* declined to participate
* genetic/chromosomal abnormalities
* any kind of sensitivity or allergy for quercetin
* history of previous hypersensitivity with quercetin

Primary outcomes:
measure: Prevalence of COVID-19 calculated using a questionnaire
timeFrame: 3 months
measure: Standardized Mortality rate
timeFrame: 3 months
Secondary outcomes:
measure: Morbidity rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT01051089: Effects of Lifestyle Modification on Metabolic Parameters in Type 2 Diabetic Patients
Official title: Effects of Lifestyle Modification Focusing on Exercise Intervention on Risk of Atherosclerosis and Metabolic Parameters in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
lifestyle modification
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in Korean type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* age 25 or older,
* type 2 diabetes mellitus,
* HbA1c 6.5-10% BMI 23 or higher.

Exclusion Criteria:

* type 1 diabetes,
* recent (within 3 months) cardiovascular event,
* severe hepatic or renal dysfunction,
* insulin use,
* glucocorticoid use.

Primary outcomes:
measure: HbA1c, serum adipokine levels
timeFrame: 3 months
Secondary outcomes:
measure: Body composition
timeFrame: 3 months
measure: Pulse wave velocity
timeFrame: 3 months
measure: Insulin secretion and sensitivity
timeFrame: 3 months
measure: VO2max
timeFrame: 3 months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT05799989: Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients
Official title: Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients: Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter Complications
Keywords: intravenous
intraarterial
catheter
fixation
withdrawal
dislocation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2023-04-05
Enrollment: 100
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine

Brief summary: Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. Beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. In pediatric patients, due to limited cooperation, higher risk of dislocation exists.

Detailed description: Pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.Type of catheter fixation (surgical versus atraumatic) will be evaluated. Demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.

Eligibility criteria: Inclusion Criteria:

* pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
* estimated length of catheter left in place longer than 72 hours

Exclusion Criteria:

* estimated length of catheter left in place shorter than 72 hours
* impossible patient´s evaluation after catheter insertion

Primary outcomes:
measure: Incidence of catheter extraction/dislocation
timeFrame: In 30 days after catheter insertion
Secondary outcomes:
measure: Incidence of local infectious complications
timeFrame: In 30 days after catheter insertion
measure: Incidence of systemic infectious complications
timeFrame: In 30 days after catheter insertion
measure: Incidence of thrombotic complications
timeFrame: In 30 days after catheter insertion
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital - Academic Centre for Malignant Hyperthermia of Masaryk University Brno
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References:
Clinical trial NCT03860389: The Effects of Exercise in Anxiety in Children With ASD
Official title: The Effects of a School Based Exercise Programme on Behaviour and Anxiety in Children With ASD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Anxiety
Behavior
Keywords: Autism
Anxiety
Exercise
Behaviour
Lead sponsor: Institute of Technology, Carlow
Sponsor class: OTHER
Collaborators: name: University of Reading
First posted: 2019-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.

Detailed description: This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. Local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. The age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. The exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children.

Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in anxiety levels and behaviour as a result of the exercise programme.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism spectrum disorder

Exclusion Criteria:

* Any medical condition which excludes the child from partaking in exercise

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline at Week 8 and Week 16
measure: Behaviour
timeFrame: Change from baseline at Week 8 and Week 16
Secondary outcomes:
measure: Fitness level
timeFrame: Change from baseline at Week 8 and Week 16
Other outcomes:
Locations:
city: Carlow
country: Ireland
facility: Sharon Kinsella
state: Co. Carlow
Study officials:
affiliation: IT Carlow
name: Sharon Kinsella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004829: Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Bacterial Infection
Keywords: bacterial infection
cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
immunologic disorders and infectious disorders
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa.

II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.

Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy.

Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening

Sweat chloride at least 60 mEq/L

--Prior/Concurrent Therapy--

At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic

At least 4 weeks since prior administration of any investigational drug

No concurrent antibiotics by aerosol

--Patient Characteristics--

Renal:

* Creatinine less than 2 mg/dL
* BUN less than 40 mg/dL
* No proteinuria of 2+ or greater

Pulmonary:

* FEV1 at least 75% and at least 25% of predicted
* Room air oximetry at least 88% saturation
* Able to perform pulmonary function tests
* No hemoptysis of 60 mL or greater within 30 days prior to study
* No abnormal chest X-ray

Other:

* Not pregnant
* Fertile females must use effective contraception
* No history of positive culture with Burkholderia cepacia
* No history of glucose-6-phosphate dehydrogenase deficiency
* No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pathogenesis
name: Alan Bruce Montgomery
role: STUDY_CHAIR
References:
citation: Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.