louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06930001: Etamine Processing on Episiotomy Repair Skills, Stress and Learning Attitudes in Midwifery Students
Official title: Effect of Etamine Processing on Midwifery Students' Episiotomy Repair Application Ability, Perceived Stress and Learning Attitude: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Episiotomy Repair Skills
Learning Attitude
Keywords: perceived stress
midwifery student
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Research Hypotheses H1: Midwifery students who practice Etamine have higher episiotomy repair skills than those who do not.

H2: Midwifery students who practice Etamine have lower perceived stress levels than those who do not.

H3: Midwifery students who practice Etamine have higher learning attitudes than those who do not.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for the study include students who are willing to participate in the study and who do not have any learning or working experience related to episiotomy repair.

Exclusion Criteria:

* Students with diagnosable diseases affecting their learning ability, those who have had accidents during the training and assessment sessions, and foreign nationals will be excluded from the study.

Primary outcomes:
measure: Episiotomy Repair Skill Form
timeFrame: Fifth week after the start of the application
measure: Perceived Stress Scale
timeFrame: pre-intervention
measure: Attitude Scale Towards Learning
timeFrame: pre-intervention
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Fifth week after the start of the application
measure: Attitude Scale Towards Learning
timeFrame: Fifth week after the start of the application
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03144401: Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section
Official title: Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cesarean Section
Keywords: cesarean section
Misoprostol
sublingual
uterotonics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.


Eligibility criteria: Inclusion Criteria:

* Patients booked for elective cesarean section.
* Singleton pregnancies.
* Full term pregnancies (GA 37- 42 Wks).
* Age (18-40 yrs).
* body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteria:

* Contraindication to spinal anesthesia.
* Blood dyscrasias.
* Large fibroids.
* Multiple pregnancies.
* Overdistended uterus eg. Hydramnios.
* Pre-eclampsia.
* Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl).
* Previous history of PPH.
* Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
* Placenta previa.
* Previous myomectomy.
* Extreme of BMI (\<20 or \>30 Kg/m2 ).

Primary outcomes:
measure: Need for extra uterotonics
timeFrame: 24 hours
Secondary outcomes:
measure: intraoperative blood loss
timeFrame: intraoperative
measure: postpartum hemorrhage
timeFrame: 24 hours
measure: neonatal outcome
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06204601: The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker
Official title: The Effect Of Education Given According to Meleıs' Transitional Theory on The Level of Self-Effectiveness With Anxiety and Depression to Patients With Pacemaker: A Single-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Activities
Keywords: Pacemaker,
Meleis Transition Theory,
Education,
Self-Efficacy,
Anxiety, Depression,
Nursing
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial model with pretest posttest control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

Detailed description: This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

Hypotheses of the Research H01: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the anxiety and depression levels of the patients.

H11: Training given according to Meleis's Transition Theory to patients with pacemaker implants reduces the anxiety and depression levels of patients.

H02: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the self-efficacy level of the patients.

H12: Training given to patients with pacemakers according to Meleis's Transition Theory increases the self-efficacy level of the patients.

Eligibility criteria: Inclusion Criteria:

* Patients with pacemaker implantation,
* Ages 18 and over,
* The one who is literate,
* Open to communication and collaboration,
* Patients who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Not oriented to person, place and time,
* Hearing loss,
* Cannot understand and speak Turkish and
* Patients who do not want to continue the study will be excluded from the study.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: month 1
Secondary outcomes:
measure: Self-Efficacy Scale in Chronic Diseases
timeFrame: month 1
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Hacer GOK UGUR
state: Altınordu
city: Ordu
country: Turkey
facility: Hacer GÖK UĞUR
Study officials:
affiliation: Ordu Univercity
name: Hacer GÖK UĞUR, Asos.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519701: Hydroxyurea in Young Children With Sickle Cell Anemia
Official title: Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: sickle cell anemia
hydroxyurea
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-08-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.

Detailed description: Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)

Primary outcomes:
measure: Transcranial doppler ultrasound velocity
timeFrame: 2 years
measure: Magnetic resonance imaging/angiography
timeFrame: 2 years
measure: Glomerular Filtration Rate
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Neurocognitive outcomes
timeFrame: 2 years
Secondary outcomes:
measure: Growth parameters
timeFrame: 2 years
measure: Hematological parameters
timeFrame: 2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medican Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Courtney D Thornburg, MD mS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078401: Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.
Official title: Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurofibromatosis Type 1
Keywords: Optic pathway glioma
Ophthalmological screening
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with neurofibromatosis type 1 with and without optic pathway glioma

Brief summary: The goal of this project is to get more insight into the (neuro)ophthalmological characteristics of children with neurofibromatosis type 1. This way investigators would like to update the current guidelines for follow up and treatment of optic pathway gliomas. Clinical findings will be compared with the results of Optical coherence tomography (OCT) and MRI (magnetic resonance imaging).


Eligibility criteria: Inclusion Criteria:

* neurofibromatosis type 1

Exclusion Criteria:

* no neurofibromatosis type 1

Primary outcomes:
measure: Visual acuity
timeFrame: childhood (0 to 18y)
measure: Presence of optic pathway glioma
timeFrame: childhood (0 to18y)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Catherine Cassiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06416501: The Impact of Colorectal Cancer Screening on Surgical Outcomes
Official title: The Impact of Colorectal Cancer Screening on Surgical Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prognosis
Colorectal Cancer
Screening
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent surgical intervention for CRC at Fudan University Shanghai Cancer Center.

Brief summary: This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening.

Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological T stage, pathological N stage, and survival outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent radical surgery for CRC, had confirmed stage III CRC through postoperative pathology, had no prior history of cancer before surgery, and had clear cancer detection information.

Primary outcomes:
measure: overall survival
timeFrame: the duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinxiang Li
state: Shanghai
Study officials:
References:
Clinical trial NCT02585401: Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
Official title: Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Central Retinal Vein Occlusion (CRVO)
Diabetic Macular Edema (DME)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-10-23
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.

Brief summary: The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.

Detailed description: The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.

Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).

The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate

Eligibility criteria: Inclusion Criteria:

This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.

Exclusion Criteria:

* None applied

Primary outcomes:
measure: Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph
timeFrame: Up to 8 weeks after the start of data collection
Secondary outcomes:
measure: Investigation whether physicians have received the educational materials
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Many Locations
country: Canada
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01610401: The Metformin-FMD Trial
Official title: Can Metformin Prevent Endothelial Ischemia and Reperfusion Injury? The Metformin-FMD Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemia Reperfusion Injury
Endothelial Function
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In acute myocardial infarction early restoration of coronary blood flow is the most effective strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue. Recently, it has been shown that the glucose-lowering drug metformin is able to limit IR-injury in murine models of myocardial infarction, probably by increased formation of the endogenous nucleoside adenosine. In the current research proposal, the investigators aim to translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of the brachial artery as a well-validated model of (endothelial) IR-injury.


Eligibility criteria: Inclusion Criteria:

* Age 30-50 years
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (in supine position: systolic BP \> 140 mmHg, diastolic BP \> 90 mmHg)
* Hyperlipidaemia (fasting total cholesterol \> 5.5 mmol/L or random \> 6.5 mmol/L)
* Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min)
* Professional athletes

Primary outcomes:
measure: Metformin-FMD trial: The effect of pretreatment with metformin on FMD of the brachial artery after forearm ischemia and reperfusion.
timeFrame: approx. 6 months
measure: Control trial: the effect of caffeine on the protective effect of metformin on FMD after ischemia and reperfusion.
timeFrame: approx. 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: N. Riksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: G.A. Rongen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: D.H. Thijssen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Messaoudi S, Schreuder TH, Kengen RD, Rongen GA, van den Broek PH, Thijssen DH, Riksen NP. Impact of metformin on endothelial ischemia-reperfusion injury in humans in vivo: a prospective randomized open, blinded-endpoint study. PLoS One. 2014 Apr 22;9(4):e96062. doi: 10.1371/journal.pone.0096062. eCollection 2014.
Clinical trial NCT00212901: High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
Official title: Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Kidney Disease
Keywords: Diabetes
Proteinuria
Angiotensin converting enzyme inhibitors
Angiotensin receptor antagonists
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.


Eligibility criteria: Inclusion Criteria:

1. Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR\&gt;50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
2. Controlled blood pressure (\&lt;150/\&lt;90)
3. Able to give informed consent
4. Between the ages of 18 and 75
5. Must be capable of providing a 24 hour urine collection
6. Negative BHcG test for ruling out pregnancy in women of childbearing age
7. Currently taking an angiotensin converting enzyme inhibitor

   -

Exclusion Criteria:

1. Creatinine clearance \&lt;50ml/min or 24hour protein excretion \&gt;3gm/d.
2. Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \&lt;100mmHg.
3. Serum potassium \&gt;5.5 on two separate occasions in the previous six months
4. Previous adverse reaction to angiotensin receptor antagonist medication
5. Use of NSAIDS including COX2 inhibitors
6. Pregnant or nursing women will be excluded
7. Currently taking an angiotensin receptor antagonist

   -

Primary outcomes:
measure: reducing proteinuria
Secondary outcomes:
measure: glomerular filtration rate
measure: side-effects of hypotension, postural symptom
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Ayub Akbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278901: The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori
Keywords: helicobacter pylori
urease test
13C-UBT
the focus of the study is to evaluate a possible effect of PPI therapy on Helicobacter pylori diagnostic tests
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI

Brief summary: STUDY PROTOCOL:

The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons. The patients should not be on PPI therapy . If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy (ulcers or esophagitis), the investigators will repeat the gastroscopy within a month.

During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure.

If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present.

After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become negative in the second endoscopy is considered false negative.


Eligibility criteria: Inclusion Criteria:

* Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI-

Exclusion Criteria:

* Patients younger than 18 years and older than 80 years
* Severe background diseases
* Previous eradicated helicobacter pylori infection

Primary outcomes:
measure: Effect of PPI treatment on helicobacter pylori diagnostic tests
timeFrame: 1 month of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Department of Gastroenterology, Rabin Medical Center
Study officials:
References: