louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01875900: Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation
Official title: Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resuscitation
Neonatology
Keywords: neonatal resuscitation
video-assisted learning
self-directed training
simulation
simulation-based training
simulation-based medical education
objective structured clinical examination
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Simulation-based training has been widely implemented in medical education. According to educational theories, simulation-based medical education (SBME) is associated with significant advantages, which has been investigated and proved by many studies. However, the value of SBME in comparison to other instructional methodologies remains largely unknown. Therefore, the aim of this study is to directly compare two instructional methods for neonatal resuscitation training.


Eligibility criteria: Inclusion Criteria:

* Fifth-year medical students prior to their mandatory OSCE
* Signing of informed consent

Exclusion Criteria:

* Refusal to participate in the study

The first two OSCEs in July and August will be part of a pilot study. The combined results of both examinations will be used for a sample size calculation.

Primary outcomes:
measure: Neonatal resuscitation performance
timeFrame: Students will take part in an Objective Structured Clinical Examination (OSCE) within two weeks after having participated in the course.
Secondary outcomes:
measure: Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care
timeFrame: within two weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Skills Center, Medical University of Graz
state: Styria
Study officials:
affiliation: Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria; Department of Pediatrics, University of Alberta, Edmonton, Canada
name: Georg Schmölzer, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria
name: Berndt Urlesberger, M.D.
role: STUDY_CHAIR
affiliation: Respiratory and Allergic Disease Division , Department of Pediatrics, Medical University of Graz, Austria
name: Ernst Eber, M.D.
role: STUDY_CHAIR
affiliation: Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria; Clinical Skills Center, Medical University of Graz, Austria
name: Albrecht Schmidt, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05292300: Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance
Official title: Investigation of the Efficacy of Lyophilized Dried Cornelian Cherry (Cornus Mas L.) Fruit on Anthropometric and Biochemical Parameters in Women With Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
PreDiabetes
Keywords: Cornelian Cherry
Cornus mas L.
Insulin Resistance
Nutrition
Anthropometry
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of 3 months supplementation of lyophilize dried cornelian cherry (Cornus mas L.) on women diagnosed with insulin resistance. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

Detailed description: The main purpose of this study is to determine the efficacy of the lyophilizer-dried powder form of cornelian cherry (Cornus mas L.) grown in our country on inflammation in women with insulin resistance by biochemical parameters.

Sub-objectives of the study;

* Determining the presence of inflammation in women with insulin resistance.
* Determination of the effect of cornelian cherry on both fasting blood glucose, insulin and blood lipid profile.
* Determination of both anti-inflammatory, antidiabetic and antioxidant effects of cornelian cherry.
* Determination of the effect of cornelian cherry on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of women with insulin resistance as a result of the consumption of powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 45 years with insulin resistance.
* Those who have not experienced menopause
* Those who applied to the obesity clinic
* Volunteers
* Those who signed the consent form

Exclusion Criteria:

* Those who use medicine for diabetes and thyroid diseases,
* Those taking hormone therapy
* Pregnant and lactating women
* Those with a history of cancer
* Patients with communication problems.

Primary outcomes:
measure: Change from Baseline in the Fasting Blood Glucose (mg/dl) at 12 weeks
timeFrame: 3 months
measure: Change from Baseline in the Fasting Insulin (mU/L) at 12 weeks
timeFrame: 3 months
measure: Change from Baseline in the HOMA-IR at 12 weeks
timeFrame: 3 months
measure: Change from Baseline in the BMI (kg/m2)
timeFrame: 3 months
measure: Change from Baseline in the Anthropometric Measurements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Maltepe
Study officials:
affiliation: Marmara University
name: Fatma Esra Güneş, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04591600: Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients
Official title: Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: Ivermectin
Doxycycline
COVID-19
Coronavirus
SARS-CoV-2
Lead sponsor: Alkarkh Health Directorate-Baghdad
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .

Detailed description: Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patients at any stage of this disease

Exclusion Criteria:

* Patients of allergic history to Ivermectin or to doxycyline

Primary outcomes:
measure: Mortality rate
timeFrame: Up to 8 weeks
measure: Rate of progression disease
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Time to recovery
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Akarkh Healt hdirectorate
Study officials:
References:
Clinical trial NCT06571500: Growth Hormone Resistance of Beta-cells in Women and People
Official title: Growth Hormone Resistance of Beta-cells in People With a Family History of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of obese men and women ages 18-45 with and without a first degree relative with type 2 diabetes.

Brief summary: The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years old
* hemoglobin HbA1c ≤5.6% and fasting blood glucose \<100 mg/dl
* body mass index ≥30.0 kg/m2 and \<45.0 kg/m2

Additional, group-specific inclusion criteria:

* Family history of type 2 diabetes: first degree relative with type 2 diabetes
* Control group: no family history of type 2 diabetes

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study, or breastfeeding
* Current diagnosis or history of type 1 or type 2 diabetes
* Use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)
* History of bariatric surgery
* Known hypothyroidism or use of thyroid medications
* History of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment
* Current cancer or cancer that has been in remission less than 5 years
* First degree relative with type 1 diabetes diagnosis
* Evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)
* Alcohol use disorder, use of controlled substances, or smoking \>2 cigarettes per day
* Greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration
* Mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent

Primary outcomes:
measure: Beta-cell function
timeFrame: 15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01665300: Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity
Official title: Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Function Systolic Dysfunction
Cardiotoxicity
Keywords: myocardial deformation imaging
Trastuzumab
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators evaluated serial echocardiograms (baseline, 3, 6, 9, and 12 months)from 120 consecutive female patients receiving trastuzumab as part of their treatment for either early or advanced breast cancer.

Brief summary: Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.

Detailed description: The investigators will prospectively evaluate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR) and identify possibility of early detection of LV dysfunction in patients treated with trastuzumab.

Eligibility criteria: Inclusion Criteria:

* HER2(+) breast cancer, anticipating Trastuzumab therapy

Exclusion Criteria:

* Refusal to informed consent
* Congenital heart disease
* Significant arrhythmia in EKG
* Regional wall motion abnormality (+) in echocardiography
* Poor sonic window

Primary outcomes:
measure: LV systolic dysfunction
timeFrame: 3-month F/U
Secondary outcomes:
measure: LV systolic dysfunction
timeFrame: 6,9, and 12-month F/U
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyung-Kwan Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173700: Empowering Parental Caregivers
Official title: Empowering Parental Caregivers: A Virtual Support Group With Problem Solving Training for Parents/Guardians of Children With SCI/D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial was to learn about the feasibility and pilot outcome measures in caregivers of children with spinal cord injury who completed a 7-week problem-solving training web-based group. The main question it aims to answer is: What is the feasibility of a seven-week, occupational therapist-facilitated, web-based support group with problem-solving training for parental caregivers of children with SCI?

Participants participated 1 time a week for seven weeks in a web-based group group:

* learning about the FOCUS problem-solving model
* applying positive coping and problem-solving strategies to current issues.


Eligibility criteria: Inclusion Criteria:

* one must be a parent or guardian of a child with a spinal cord injury or disorder, be that child's primary caregiver, and be 18 years or older.

Exclusion Criteria:

* None

Primary outcomes:
measure: Brief COPE
timeFrame: Before the group began, 7 weeks after start of group
measure: Caregiver Self-Assessment Questionnaire
timeFrame: Before the group began 7 weeks after start of group
measure: Knowledge Check
timeFrame: Before the group began 7 weeks after start of group
Secondary outcomes:
measure: Attendance
timeFrame: across the 7 weeks of the group
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: at the end of the 7 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: United Spinal Association
state: District of Columbia
Study officials:
affiliation: Duquesne University
name: Elena Donoso Brown, PhD
role: STUDY_CHAIR
affiliation: Duquesne University
name: Elena Martino, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04301700: Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effects of Progressive Muscle Relaxation and Mindfulness Meditation on Dyspnea, Fatigue and Care Dependency in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Mediation
Fatigue
Symptoms and Signs
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.

Detailed description: Previous reports have revealed that progressive muscle relaxation and meditation are decreasing symptoms burden in chronic disease. On the other hand, no study has been conducted to determine the effects of progressive relaxation exercise and mindfulness meditation on dyspnea, fatigue and care dependency in patients with COPD. The present study investigates the effects of progressive muscle relaxation and mindfulness meditation in a single-site, 3-arm, assessor-blinded randomized, controlled study of 65 COPD patients. Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease the severity of dyspnea, fatigue and care dependency.

Eligibility criteria: Inclusion Criteria:

* older than 40 years
* diagnosed with stage III-IV COPD
* had at least primary school degree
* had no cognitive dysfunction, or communication problems
* were residing in Ankara.

Exclusion Criteria:

* history of cognitive dysfunction, or communication problems
* illiteracy
* applying any complementary and integrative approach during the study
* participating in a pulmonary rehabilitation program during the study.

Primary outcomes:
measure: Change in dyspnea
timeFrame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
measure: Change in fatigue
timeFrame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
measure: Change in care dependency
timeFrame: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Secondary outcomes:
Other outcomes:
measure: Dyspnea
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altindag
Study officials:
References:
Clinical trial NCT00211900: Evaluation of Manufacturing Lot of StaphVAX
Official title: A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infections
Chronic Kidney Failure
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.


Eligibility criteria: Inclusion Criteria:

* 8 wk of hemodialysis for ESRD,
* have written informed consent,
* a negative serum pregnancy test if appropriate,
* and expect to comply with protocol procedures and schedule

Exclusion Criteria:

* known HIV,
* immunomodulatory drugs,
* malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
* active infection in the 2 weeks prior to study injection,
* serious S. aureus infection within the last 3 months prior to injection,
* use of investigational drugs, vaccines or devices within the prior 30 days,
* hypersensitivity to components of StaphVAX

Primary outcomes:
measure: Type-specific antibody concentrations
timeFrame: 6 weeks after vaccine dose
Secondary outcomes:
measure: Type-specific antibody concentrations
timeFrame: 3 weeks after vaccine dose
measure: Elicited vaccine reactogenicity.
timeFrame: daily for 7 days after dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Trialogic Research
state: Alabama
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Matt Hohenboken, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06765200: Effectiveness of a Digital Treatment for Adolescents with Chronic Pain
Official title: Effectiveness of a Digital Treatment for Adolescents with Chronic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
mhealth
adolescent
mobile application
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2025-01-09
Enrollment: 195
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research has shown that the prevalence of chronic pain in adolescents is high and increasing. These young people report significant changes in both their physical and psychological functioning. Currently, psychosocial treatments enjoy strong empirical support and are crucial to maintaining and improving the quality of life of adolescents suffering from chronic pain. However, the availability of these evidence-based interventions is insufficient to meet the high demand, especially outside of large cities. The aim of this project is to develop a digital treatment that helps improve the quality of life of adolescents with chronic pain and complementary websites for their parents and teachers.


Eligibility criteria: Inclusion Criteria:

* 12-18 years old,
* Having a non-oncology secondary chronic pain problem,
* Having internet access,
* A parent willing to participate in the study,
* Providing informed consent/assent.

Exclusion Criteria:

* Cognitive or language problems

Primary outcomes:
measure: Pain intensity
timeFrame: baseline, 8 weeks, 3 months follow-up
measure: Pain interference
timeFrame: baseline, 8 weeks, 3 months follow-up
measure: Global perception of change after treatment
timeFrame: 8 weeks, 3 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Universitat Rovira i Virgili
Study officials:
affiliation: University Rovira i Virgili
name: Jordi Miró
role: PRINCIPAL_INVESTIGATOR
References: