louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02100215: Quantifying the Influence of Expert Modeling
Official title: Quantifying the Influence of Expert Modeling on Novice Nurse Competence and Self-Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Competence
Self-efficacy
Keywords: simulation
competence
self-efficacy
novice nurses
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about the effects of various types of simulation preparation methods on novice nurses' competence and self-efficacy. Participants will be recruited from an academic course (N424 Integrated Practicum). Participants will be randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint, and traditional readings). All participants will complete self-efficacy surveys and two simulations. During simulation, participants will be scored based on their competence according to a performance rubric. The hypothesis is that participants in the expert modeling group will demonstrate more change in competence and report more change in self-efficacy scores than participants in other groups.

Detailed description: Investigators will compare self-confidence and competence scores between the three groups after the pre-test and posttest simulations. The self-efficacy survey is an 7-item scale that involves participants rating their self-efficacy about providing care for multiple patients. Participants rate their self-efficacy on a 1 to 5 (not confident to very confident scale). The survey takes 5 minutes to complete. The self-efficacy survey has been used in many simulation research studies previously with novice nurses. Competence will be measured with a rater-observation measure which has previously been used in simulation research.

Eligibility criteria: Inclusion Criteria:

* Enrolled in capstone clinical course
* Oregon Consortium for Nursing Education curriculum
* Ashland, OR

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Creighton Simulation Evaluation Instrument
timeFrame: Change from baseline on Creighton Simulation Evaluation Instrument at 5 weeks
Secondary outcomes:
measure: National League for Nursing Student Satisfaction and Self-Confidence with Learning scale
timeFrame: Change from baseline on NLN Student Satisfaction and Self-Confidence with Learning scale at 5 weeks
Other outcomes:
Locations:
city: Ashland
country: United States
facility: Oregon Health & Science University, School of Nursing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ashley Franklin
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Christopher S Lee, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01667315: Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block
Official title: Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Shoulder Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 33
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: TREATMENT

Brief summary: The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.


Eligibility criteria: Inclusion Criteria:

* Age between 21 and 65 years
* Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
* Physical condition of I or II according to the American Society of Anesthesiologists
* Body mass index up to 35 kg.m-2

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Cognitive impairment or active psychiatric condition
* Infection at the site of the puncture for the block
* Coagulopathy
* Bupivacaine allergy

Primary outcomes:
measure: Minimum effective volume of 0,375% bupivacaine
timeFrame: 30 minutes
Secondary outcomes:
measure: Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function
timeFrame: Before block, 10, 20 and 30 minutes, 4 and 6 hours after
measure: Pulmonary function
timeFrame: Before block, 30 minutes, 4 and 6 hours after
measure: Diaphragmatic Function
timeFrame: Before block, 30 minutes, 4 and 6 hours after
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
References:
Clinical trial NCT02345915: Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia
Official title: Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloid, Acute
Acute Lymphoid Leukemia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Aix Marseille Université
First posted: 2015-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.


Eligibility criteria: Inclusion Criteria:

* Young adult (18-40 years) Leukemia survivor, in complete remission.
* Acute leukemia diagnosed since January 1980 .
* Patient Affiliated to social security or beneficiary
* Signed Informed Consent prior to any screening procedures

Exclusion Criteria:

* Emergency
* Patient unable to abide by the study protocol (for geographical, social or psychological reasons)

Primary outcomes:
measure: Late sequelae evaluation of young adult acute leukemia-survivors
timeFrame: 24 mois
measure: Quality-of-life assessment of young adult acute leukemia-survivors
timeFrame: 24 mois
Secondary outcomes:
measure: Comparison of the frequency of sequelae between children/adolescents (LEA cohort) and young adults acute leukemia survivors (LEA-JA)
timeFrame: 24 mois
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Norbert VEY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789515: Defunctioning Stoma and Postoperative Morbidity
Official title: Diverting Stoma and Postoperative Morbidity After Low Anterior Resection for Rectal Cancer Within an Enhanced Recovery After Surgery,ERAS, Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loopileostomy
Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ersta Hospital, Sweden
First posted: 2013-02-12
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer

Brief summary: In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure. Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery. The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database

Exclusion Criteria:

* none

Primary outcomes:
measure: Clinical anastomotic leakage
timeFrame: 0 to 9 years after surgery
Secondary outcomes:
measure: Permanent stoma
timeFrame: 0 to 9 years after surgery
Other outcomes:
measure: Total days of hospital stay
timeFrame: 0-9 years after surgery
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kajsa Anderin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974215: Peri Implant Marginal Bone Height and Bone Density
Official title: Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Keywords: Bone height
Bone density
Implant supported
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.

Detailed description: In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups.

Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture.

All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT).

Measurements will be obtained at denture insertion, after 1 month and after 3 months.

Eligibility criteria: Inclusion Criteria:

* Non-smoker Patients
* Highly cooperative and motivated patients.
* Patients Systemically free from any immunosuppressive diseases.

Exclusion Criteria:

* Diabetic, hypertensive, cancer patients.
* Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies.
* Patients with temporo-mandibular joint disorders and bad oral habits.

Primary outcomes:
measure: assessment of change of bone height around dental implants
timeFrame: on the first day, on 30th day, 90th day
measure: assessment of change of bone density around dental implants
timeFrame: on the first day, on 30th day, 90th day
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
affiliation: National Research Centre, Egypt
name: Menatallah Elhotieby, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811615: Efficacy of New Alcohol Free Mouthrinses
Official title: A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gum Disease
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2013-03-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.

Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* participants between 18 and 65 years
* no severe periodontitis
* informed consent

Exclusion Criteria:

* handicapped participants
* allergies against mouth rinses

Primary outcomes:
measure: Modified Proximal Plaque Index (MPPI)
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University School of Dental Medicine
state: NRW
Study officials:
affiliation: Witten/Herdecke University
name: Stefan Zimmer, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00992615: Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
Official title: Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2009-10-09
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18
* Patients with a PSA value between 3 et 20 ng/ml
* Obtained informed consent
* Patients able to comply with the study protocol
* Patients covered by a social insurance

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie
Study officials:
References:
citation: Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, Mottet N. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol. 2013 Jul;190(1):77-83. doi: 10.1016/j.juro.2012.12.109. Epub 2013 Jan 9.
Clinical trial NCT01885715: Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
Official title: Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observation of Neuromuscular Block
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia

Exclusion Criteria:

* BMI \>25 or \< 20 kg/m2
* Patients taking intercurrent medication
* Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase \> 40 IU/L, Cr \> 1.4 mg/dl

Primary outcomes:
measure: time to reverse from light muscle relaxation
timeFrame: time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine
Secondary outcomes:
measure: time to reverse from TOF ratio 0.5 to 0.9
timeFrame: time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Eunsu Choi
state: Gyeonggi-do
Study officials:
affiliation: Professor
name: Ah Young Oh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747315: A Diagnostic Test for Familial Mediterranean Fever
Official title: Assessment of a Functional Test to Detect Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Mediterranean Fever
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 107
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Familial Mediterranean Fever, patients controls with similar symptoms and healthy subjects who donated their blood to the French Blood Establishment.

Brief summary: Familial Mediterranean Fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is due to mutations of the MEFV gene, encoding variants of the Pyrin inflammasome. Inflammasomes are protein complexes of innate immunity producing pro-inflammatory cytokines (interleukin-1β).

In vitro, preliminary results demonstrated that activation of the Pyrin inflammasome (measured by interleukin-1β concentration) by kinase inhibitors is significantly increased in FMF patients compared to subjects with a similar clinical picture, and healthy controls. In addition, a measure of cell death yielded significant results in differentiating patients from controls.

The investigators hypothesize that this fast and simple functional test can serve as a diagnostic tool for FMF.


Eligibility criteria: Inclusion Criteria:

* Clinical picture compatible with an Familial Mediterranean Fever and an earlier genetic analysis finding a mutation of the MEFV gene;
* Newly diagnosed or undergoing follow-up (without criteria of delay or evolutionary stage);
* In the course of specific or non-specific treatment of the disease or without treatment;
* For whom a blood test is planned as part of the routine care;
* Of whom the informed non-opposition has been collected (parental authorization in the case of a minor patient);

Exclusion Criteria:

* patient under legal protection or under safeguard of justice or any other measures of protection (guardianship, curatorship);
* Person unable to express his consent;
* Person in emergency situation, vital or not;
* Infection known to HIV and / or HBV and / or HCV

Primary outcomes:
measure: Differences in interleukin-1bβ levels
timeFrame: Less than 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de néphrologie et rhumatologie pédiatrique, Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Unité Inserm U1111 & Service de Médecine Interne, Hôpital de la Croix-Rousse
city: Lyon
country: France
facility: Service de Médecine Interne, Pavillon O - Hopital Edouard Herriot
city: Pierre-Bénite
country: France
facility: Service de Médecine Interne et pathologies vasculaires, Batiment 1B, Centre Hospitalier Lyon Sud
Study officials:
References: