louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01881672: Syndrome and Aspiration Pneumonia in Intensive Care
Official title: Syndrome and Aspiration Pneumonia in Intensive Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Patients
Under Mechanical Ventilation
In State of Coma (Define by Glasgow ≤ 8)
No Antibiotic Treatment
Keywords: Aspiration pneumonia
Coma
Mechanical ventilation
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for coma (define by Glasgow score \< 8) and under mechanical ventilation. Suspicion of bacterial inhalation pneumonia will be confirme by a protected distal sampling during a flexible bronchoscopy.

Brief summary: Inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of ICU stay increased. However, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known.

The aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation


Eligibility criteria: Inclusion Criteria:

* Altered consciousness defined by a Glasgow Coma Scale score less than or equal to 8 before protection of the upper airway by endotracheal intubation
* Patient under mechanical ventilation

Exclusion Criteria:

* Patient with pre-existing impairment of laryngeal function in Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, laryngeal cancer, radiotherapy laryngeal
* Patient under guardianship
* Inpatient without consent
* Pregnant woman
* Patient previously treated with antibiotics for more than 24 hours at the time of ICU admission
* Patient with infection at ICU admission which justified probabilist antibiotic treatment
* Lack of social security
* Refusal of the patient or their next of kind

Primary outcomes:
measure: Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
timeFrame: ICU Discharge
Secondary outcomes:
measure: Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation
timeFrame: ICU Discharge
measure: Description of the bacterial flora identified in respiratory specimens.
timeFrame: ICU Discharge
measure: Identification of predictive factors for development of bacterial pneumonia
timeFrame: ICU Discharge
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: CHD Vendee
Study officials:
affiliation: CHD Vendee
name: Jean Baptiste Lascarrou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572272: Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
Official title: Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubated Neonates That Require Conventional Ventilation
Keywords: Distal Capnography
CO2
neonates
conventional ventilation
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated neonates that require conventional ventilation

Brief summary: Primary:

The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions

Sub Study:

• Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).

Description of Study Design:

Patients will be randomized at the baseline evaluation visit into one of the following groups:

* Masked group: Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
* Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary.


Eligibility criteria: Inclusion Criteria:

* Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico) that their respiratory condition requires conventional ventilation.
* Obtaining signed Informed Consent Form by the parents or legal guardian
* Intubated neonates that are expected to provide at least 3 pairs of blood samples and ETCO2 measurements during ventilation period

Exclusion Criteria:

* Intubated neonates with single-lumen ETTs
* Neonates who are ventilated with HFV
* Any significant medical condition which, at the investigator's discretion, may interfere with the study.

Primary outcomes:
measure: Compare between the open and the masked group in the following: the percentage of measurement points at the Safe range: 60>PaCO2>30, Normal range 45>PaCO2>35 and Adequate (permissive) range: 45-55.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka MC
city: Haifa
country: Israel
facility: Bnai Zion MC
city: Jerusalem
country: Israel
facility: Shaare Zedek MC
Study officials:
affiliation: Bnai Zion MC, Haifa Israel
name: Amir Kugelman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kugelman A, Golan A, Riskin A, Shoris I, Ronen M, Qumqam N, Bader D, Bromiker R. Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study. J Pediatr. 2016 Jan;168:56-61.e2. doi: 10.1016/j.jpeds.2015.09.051. Epub 2015 Oct 17.
Clinical trial NCT02844972: Interest of Pain Assessment by the Family of Patients in Limiting and Stopping Active Treatment Process Admitted in ER. Study DOFAMILA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient's Pain in Later Life
Keywords: arrest or limitation of active treatment
emergency treatment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 200
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: non communicating patients admitted in emergency ward

Brief summary: Decisions to limit and stop active therapeutics are common in the emergency unit. They are framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable obstinacy and care of the patient's pain in later life. The pain assessment is an issue for these patients whose in majority, are not communicating. Moreover, no specific tool and the teams in charge, not knowing the patient make the recognition and treatment of pain symptoms very complex. This is the potential interest of directly involving the family or the person of confidence in this management , the first step being the detection and evaluation of pain.


Eligibility criteria: Inclusion Criteria:

* Adults older than 18
* non communicating patients admitted in emergency ward
* unanimous decision of stopping and limiting active treatment according to Leonetti's law of April 22nd, 2005
* Presence of a member of the patients family or one of his legal representative

Exclusion Criteria:

* Children
* no health insurance

Primary outcomes:
measure: simplified verbal scale
timeFrame: admission time in ER (Day 1)
Secondary outcomes:
measure: simplified verbal scale
timeFrame: 24 hours after the decision of limiting or stopping active treatment in emergencies
measure: Algoplus scale
timeFrame: at admission (Day 1)
measure: PAINAD scale
timeFrame: at admission (Day 1)
measure: CAESAR scale
timeFrame: 24 hours after admission
measure: CAESAR scale
timeFrame: 3 weeks after admission
Other outcomes:
Locations:
city: Lyon
country: France
facility: ER unit Hospital Edouard Herriot, Hospices Civils de Lyon
Study officials:
affiliation: ER unit Hospital Edouard Herriot, Hospices Civils de Lyon
name: Laurent JACQUIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Douplat M, Daoud K, Berthiller J, Schott AM, Potinet V, Le Coz P, Tazarourte K, Jacquin L. Poor Involvement of General Practitioners in Decisions of Withholding or Withdrawing Life-Sustaining Treatment in Emergency Departments. J Gen Intern Med. 2020 Jan;35(1):177-181. doi: 10.1007/s11606-019-05464-y. Epub 2019 Nov 4.
Clinical trial NCT02867072: Laparoscopic Versus Open Appendectomy
Official title: Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Appendicitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 593
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care

Primary outcomes:
measure: Hospital cost
timeFrame: 3 days
measure: Wound infection
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Biondi A, Di Stefano C, Ferrara F, Bellia A, Vacante M, Piazza L. Laparoscopic versus open appendectomy: a retrospective cohort study assessing outcomes and cost-effectiveness. World J Emerg Surg. 2016 Aug 30;11(1):44. doi: 10.1186/s13017-016-0102-5. eCollection 2016.
Clinical trial NCT06373172: Enhancing Clinical Reasoning Competency
Official title: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education Based on the Rasch Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Reasoning
Communication
Development, Human
Lead sponsor: Tongmyong University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This quasi-experimental study used a single-group pretest-posttest design to verify the effectiveness of virtual simulation-based education for undergraduate nursing students.
Primary purpose: OTHER

Brief summary: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch model

Aims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education.

Detailed description: Methods: This study used a single-group pre- and post-test experimental design to verify the effectiveness of virtual simulation-based education. Data were collected from June to September 2020. Thirty-six nursing students in the 3rd and 4th grades who understood the purpose of this study were selected as participants. The collected data were analyzed using SPSS Statistics 25.0 and Winsteps 3.68.2.

Keywords: Clinical Reasoning, Competency, Communication, Nursing, Virtual Simulation

Eligibility criteria: Inclusion Criteria:

* The participants were third- and fourth-year undergraduate nursing students who understood the purpose of the study and voluntarily agreed to participate

Exclusion Criteria:

* A person who has difficulty communicating or has no willingness to participate

Primary outcomes:
measure: Nurses Clinical Reasoning Scale
timeFrame: 4month
measure: Communication Skills Scale
timeFrame: 4month
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Tongmyong Unoversity
Study officials:
affiliation: Tongmyong University
name: Sung Hae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188472: Pentriox - Induction of Oxidative Stress
Official title: PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxidative Stress
Keywords: Oxidative Stress
antibiotics
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Klinisk Biokemisk Afdeling
name: Klinisk farmakologisk Afdeling
name: Sektion for Biomedicin Institut for Veterinær Patobiologi
First posted: 2014-07-11
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and trimethoprim's possible induction of oxidative stress in human cells. The induction is examined by comparing changes in oxidative stress in the treatment group with the change in a placebo group. The study is a randomized-based placebo-controlled study. Each treatment group consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.


Eligibility criteria: Inclusion Criteria:

* Caucasian
* healthy men
* non-smoker
* 18-35 years
* BMI: 18-30

Exclusion Criteria:

* Smoker
* high blood pressure
* allergies towards any of the tested medicine
* galactose-intolerance
* abnormal lipid profile
* CRP \> 10
* Glucose/galactose-malabsorption
* Use of medications and herbal remedies that affect/are affected by v-penicillin and trimethoprim
* intake of narcotics 2 months prior to trial
* intake of supplements 1 month prior to trial
* bronchial asthma
* allergies
* heart deficiencies
* brady cardia
* kidney disease
* liver disease
* hypo-potassium
* phenylketonuria

Primary outcomes:
measure: Urinary excretion of 8-oxoguanosine (nmol/24h)
timeFrame: Change from Baseline after seven days of treatment
measure: Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)
timeFrame: Change from Baseline after seven days of treatment
Secondary outcomes:
measure: Malondialdehyde
timeFrame: At the screening visit and at the final visit
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Pharmacology
Study officials:
affiliation: Department head
name: Henrik E Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524872: Implant/Abutment Module Stability of Original vs Compatible Connections
Official title: Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss, Alveolar
Dental Implant Failure Nos
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.

The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.

The hypothesis is that original components will present significantly better stability than non-original abutments.


Eligibility criteria: Inclusion Criteria:

* Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.

Exclusion Criteria:

* general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
* patients \<18 years of age,
* smoking habit (\>10 cigarettes/day),
* sites with acute infection or requiring regenerative procedures,
* Full Mouth Plaque Score
* Full Mouth Bleeding Score \>25 %,
* pregnant and lactating.

Primary outcomes:
measure: Biological complications
timeFrame: 1 year
measure: Biomechanical complications
timeFrame: 1 year
Secondary outcomes:
measure: Microbial loads
timeFrame: 1 year
measure: Probing Pocket Depth
timeFrame: 1 year
measure: Modified Plaque Index
timeFrame: 1 year
measure: Bleeding on Probing
timeFrame: 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Study officials:
References:
Clinical trial NCT00686972: The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Official title: The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bariatric Surgery
Keywords: Bariatric Surgery
Glucose Regulation
Cardiac Function
Body Composition
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.

Detailed description: The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers 21-65 years.
* BMI \> 40.
* Preoperative hematocrit level of at least 34% for women and 38% for men.
* Postoperative hematocrit level of at least 34% for women and 36% for men.

Exclusion Criteria:

* Volunteers whose hematocrit level does not meet the above criteria.
* Pregnant and or lactating females.

Primary outcomes:
measure: Insulin Secretion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
References: