louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06840353: The Effect of Intramuscular Ventrogluteal Injection Training Given by Pecha Kucha Method
Official title: The Effect of Intramuscular Ventrogluteal Injection Training Given by Pecha Kucha Method on Nursing Students' Knowledge, Skills and Satisfaction Levels: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site
Keywords: Pain
Nursing
Education
Injections, Intramuscular
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind parallel group randomized controlled trial
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the effect of intramuscular Ventrogluteal injection training given with the Pecha Kucha method on the knowledge, skill and satisfaction levels of nursing students.

Detailed description: Intramuscular injection is a very important intervention among basic nursing skills. Intramuscular injection technique to the ventrogluteal region is one of the safest injection techniques. In teaching this technique, both the knowledge and skills of the students can be increased by using different education methods. This research will be carried out to determine the effect of intramuscular ventrogluteal injection training given with the Pecha Kucha method on the knowledge, skill and satisfaction levels of nursing students.

Method: Data will be collected with the Introductory Information Form, Knowledge Test for Intramuscular Injection to the Ventrogluteal Region, Skill Test for Intramuscular Injection to the Ventrogluteal Region, Satisfaction Visual Analog (VAS) Scale. Data will be collected face to face between March 2025 and May 2025.

Eligibility criteria: Inclusion Criteria:

* Taking the Fundamentals of Nursing course for the first time
* Being between the ages of 18-25
* Students who can speak and understand Turkish fluently.
* Students who accept to participate in the study voluntarily.

Exclusion Criteria:

* Students who have previously taken the Fundamentals of Nursing 1st year course.
* Students who are graduates of Health Vocational High School.
* Students who have transferred to the nursing department with the vertical transfer exam.

Primary outcomes:
measure: Knowledge Test for Intramuscular Injection to the Ventrogluteal Region
timeFrame: 15 minutes after training, 1 month after training
Secondary outcomes:
measure: Skill Test for Intramuscular Injection to the Ventrogluteal Region
timeFrame: 2 hours later after training, 1 month after training
measure: Satisfaction Visual Analog (VAS) Scale:
timeFrame: 15 minutes after training
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Hilal Türkben Polat
Study officials:
References:
Clinical trial NCT00099853: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c after 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c <7% after 24 weeks
measure: Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
measure: Adverse event profile after 24 weeks of treatment
measure: Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.
Clinical trial NCT05086653: Complications From Left Atrial Appendage Occluder
Official title: The Management of Left Atrial Appendage Perforation Complicated by Cardiac Tamponade During Left Atrial Appendage Occluder Device Deployment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Cardiac Perforation
Cardiac Tamponade
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: one female patient involved

Brief summary: The following case reported a rare complication of left atrial appendage perforation complicated by cardiac tamponade during LAAO device deployment and its corresponding surgical management


Eligibility criteria: Inclusion Criteria:

* 73-year-old woman with CHA2DS2-VASc score 4

Exclusion Criteria:

* nil

Primary outcomes:
measure: Treatment related adverse events
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Surgery, Division of Cardiovascular Surgery
Study officials:
References:
Clinical trial NCT01867853: Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
Official title: Volume Responsiveness Before Spontaneous Breath Trial Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
First posted: 2013-06-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were mechanically ventilated and ready to undergo a spontaneous breathing trial (SBT) with a T-piece

Brief summary: To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.

Detailed description: 82 patients, 61 succeed and 21 failed

Eligibility criteria: Inclusion Criteria:

* mechanical ventilation

Exclusion Criteria:

* pregnancy or breast-feeding
* tracheostomy at baseline
* myasthenia gravis or acute polyradiculoneuropathy
* end-stage chronic illness

Primary outcomes:
measure: changes of cardiac index
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Zhimin DOU
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
citation: Eskandar N, Apostolakos MJ. Weaning from mechanical ventilation. Crit Care Clin. 2007 Apr;23(2):263-74, x. doi: 10.1016/j.ccc.2006.12.002.
citation: MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
citation: Monnet X, Teboul JL, Richard C. Cardiopulmonary interactions in patients with heart failure. Curr Opin Crit Care. 2007 Feb;13(1):6-11. doi: 10.1097/MCC.0b013e328013c865.
citation: Teboul JL, Monnet X. Detecting volume responsiveness and unresponsiveness in intensive care unit patients: two different problems, only one solution. Crit Care. 2009;13(4):175. doi: 10.1186/cc7979. Epub 2009 Aug 10.
citation: Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
Clinical trial NCT05055453: MyPhonak App Junior Pediatric Usability and Benefit Investigation
Official title: ESolutions Functions for Children and Young People With the myPhonak App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents between the ages of 7 and 17 years old.
* bilateral mild to severe hearing loss
* experienced hearing aid users for 6+ months

Exclusion Criteria:

* any additional disabilities to the hearing impairment
* inability to complete the study procedures

Primary outcomes:
measure: dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test
timeFrame: Day 1 of study, repeated on Day 14 of study
Secondary outcomes:
measure: Assessment of Hearing Situations in Children's Every Day Lives Questionnaire
timeFrame: Completion of first home trial at day 7, and completion of second home trial at day 14
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, HNO-Klinik
state: Rheinland-Pfalz
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Anne K Läßig, M.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614053: Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage
Official title: Continuous Non Invasive Monitoring of Both Plethysmography Variability Index and Total Hemoglobin During Cesarean Section for Antepartum Hemorrhage As a Method For Early Detection of Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antepartum Hemorrhage
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: parturients with antepartum hemorrhage admitted for cesarean section

Brief summary: The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .


Eligibility criteria: Inclusion Criteria:

* Anesthesiologist (ASA) Physical status I - II.
* patients aged from 18 to 40 years
* full-term multigravida parturients
* antepartum hemorrhage
* singleton fetus

Exclusion Criteria:

* Patients with known cardiac problem
* peripheral circulatory failure of the upper extremities
* significant liver disease
* significant renal disease
* significant coagulopathy

Primary outcomes:
measure: Pleth Variability Index
timeFrame: 8 months
Secondary outcomes:
measure: hemoglobin level
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: professor of anaesthesia cairo university
name: nadia yo helmy, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT04939753: Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis
Official title: Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrogenic Diabetes Insipidus
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who were admitted to the Intensive Care Unit (ICU) of the UZ Brussels in the last 10 years (March 1st 2011- March 1st 2021) and who received prolonged sedation (\>24h) with sevoflurane.

Brief summary: The investigators aim to retrospectively explore the electronic medical records of all patients who were admitted to the Intensive Care Unit (ICU) of the UZ Brussels in the last 10 years (March 1st 2011- March 1st 2021) and who received prolonged sedation (\>24h) with sevoflurane.


Eligibility criteria: Inclusion Criteria:

* Sevoflurane administration \>24h
* 18 years and older

Exclusion Criteria:

* \< 18 years old
* Pre-existing diabetes insipidus
* Use of drugs at risk for diabetes insipidus (including lithium, cisplatin)
* Hypercalcemia (persistently \>2.75 mmol/L)
* Pituitary or acute brain surgery
* Patients requiring continuous renal replacement therapy
* Pregnancy

Primary outcomes:
measure: Nephrogenic Diabetes Insipidus prevalence
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Number of patients that develop risk factors of NDI
timeFrame: up to 8 weeks
measure: Amount of time patient was placed under sevoflurane sedation.
timeFrame: up to 8 weeks
measure: Number of patients with electrolyte abnormalities as assessed by lab results.
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of patients with excessive urine output
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of patients with an abnormal physical examination.
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of patients with urine with an abnormal osmolality
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of patients that show an abnormal amount of fluid intake
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of patients that have an abnormal abdominal echo of the bladder.
timeFrame: during hospitalization, up to 8 weeks.
measure: Number of symptoms of NDI
timeFrame: up to 8 weeks
measure: Timing of symptoms of NDI
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT06813053: A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
Official title: A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Early-Stage
Newly Diagnosed
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Association of Academic Surgery
First posted: 2025-02-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.

Detailed description: This pilot study will utilize several tools and instruments to measure various aspects of of the implementation of the decision aid. 1. BREAST-Q patient-Reported Outcomes, 2. Ottawa Decision Aid Evaluation Measures, 3. Health Literacy Assessments, 4. Distress Screening Tools, 5. Web-Based Surveys, 6. Semi-Structured Interviews.

Eligibility criteria: Inclusion Criteria:

* Adult women age 18-100
* English speaking
* Clinical stage 0-III breast cancer
* Eligible for both lumpectomy and mastectomy

Exclusion Criteria:

* Prior surgical consultation regarding treatment options for breast cancer
* Previous history of breast cancer
* Requires neoadjuvant chemotherapy prior to surgical intervention

Primary outcomes:
measure: Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients
timeFrame: 1 year
measure: Evaluate how well patients receive the decision aid
timeFrame: 1 year
Secondary outcomes:
measure: Maximize patient engagement with the decision aid
timeFrame: 1 year
measure: Obtain pilot data for a large scale randomized controlled trial comparing use of the decision aid to standard of care in early-stage breast cancer patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Universtiy of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: UCHealth Cherry Creek Medical Center
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Highlands Ranch Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah Tevis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520753: Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for longer than 12 months
* Body mass index (BMI) below 35.0 kg/m\^2
* HbA1c below 11.0 %
* Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

* Current treatment with agents affecting glucose metabolism
* History of drug or alcohol dependence
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Recurrent severe hypoglycaemia or advanced neuropathy

Primary outcomes:
measure: Fasting serum glucose
Secondary outcomes:
measure: 24-hour serum glucose profiles
measure: 24-hour insulin profiles
measure: Incidence of hypoglycaemic episodes
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.