louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00221572: Can Quantitative Ultrasound be Used for the Evaluation of Bone Health in Adolescents and Adults With Cystic Fibrosis
Official title: Can Quantitative Ultrasound be Used for the Evaluation of Bone Health in Adolescents and Adults With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cystic Fibrosis

Brief summary: Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation to serum bone parameters, use of steroids, lung function and nutritional status.

Detailed description: Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation to serum bone parameters, use of steroids, lung function and nutritional status.

Eligibility criteria: Inclusion Criteria:

* Patients with Cystic Fibrosis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Stephanie Van Biervliet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04890080: Resting Heart Rate in Chronic Obstructive Pulmonary Disease
Official title: Improvement of Resting Heart Rate After Exercise Training and Its Predictors in Chronic Obstructive Pulmonary Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Rehabilitation
Exercise
COPD
Resting Heart Rate
Keywords: resting heart rate
COPD
exercise
pulmonary rehabilitation
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 110 COPD patients who were participated in the PR program were included in the study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.

Detailed description: In many studies, it has been reported that baroreceptor activity and heart rate variability decrease and resting heart rate (RHR) increases in COPD patients due to changes in cardiac autonomic function. Among the recommendations regarding pulmonary rehabilitation (PR) and exercise training in COPD patients, approaches such as including practices targeting RHR and developing implementation strategies that improve the cardiovascular system are recommended. The primary aim of our study is to examine the effect of comprehensive exercise training consisting of breathing, aerobic and strengthening exercises on RHR in COPD patients, and secondarily to determine the factors that affect RHR change after PR in COPD patients.

110 COPD patients who were participated in the PR program were included in our retrospective study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program

Exclusion Criteria:

* With cardiovascular disease
* With additional diseases such as diabetes
* Receiving medical treatment that affects the autonomic nervous system
* Patients receiving long-term oxygen therapy

Primary outcomes:
measure: Resting Heart Rate
timeFrame: 1 minute
Secondary outcomes:
measure: Functional Capacity
timeFrame: Change from baseline six minute walk distance at 8 week
measure: Dyspnea Assessment
timeFrame: Change from baseline dyspnea at 8 week
measure: Quality of Life Assessment
timeFrame: Change from baseline dyspnea at 8 week
measure: Anxiety and Depression
timeFrame: Change from baseline dyspnea at 8 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01818180: Urell and Pregnancy
Official title: Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Tract Infection (UTI)
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).


Eligibility criteria: Inclusion Criteria:

- Pregnant woman in her 4th gestational month or more, having urinary tract infection.

Exclusion Criteria:

* Pregnant woman with organic or functional urinary tract malformations
* Diabetic patients
* HIV positive

Primary outcomes:
measure: Recurrence of Urinary tract infections
timeFrame: From the 4th gestational month till the end of pregnancy (about the 40th gestational week)
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Hôpital FOCH 40, rue Worth 92150 Suresnes
name: Jean Marc AYOUBI, PU-PH
role: STUDY_CHAIR
References:
Clinical trial NCT03092180: Optimizing Treatment on Idiopathic Inflammatory Myopathies
Official title: Optimizing Treatment on Idiopathic Inflammatory Myopathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Inflammatory Myopathies
Keywords: Dermatomyositis
Immunomodulation
Immunosuppressive agents
Myositis
Polymyositis
Necrotizing myopathies
Antisynthetase syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic inflammatory myopathies

Brief summary: As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.

This scheme is an internal routine protocol of our Service.

Detailed description: To compare two groups of patients as described in Brief Summary.

Eligibility criteria: Inclusion Criteria:

* Idiopathic inflammatory myopathies

Exclusion Criteria:

* Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

Primary outcomes:
measure: Physician Global Activity
timeFrame: Six months
measure: Patient/Parent Global Activity -
timeFrame: Six months
measure: Manual Muscle Testing
timeFrame: Six months
measure: Health Assessment Questionnaire
timeFrame: Six months
measure: Muscle Enzymes
timeFrame: Six months
measure: Myositis Disease Activity Assessment Tool
timeFrame: Six months
Secondary outcomes:
measure: Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)
timeFrame: Six months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel Katsuyuki Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03643380: Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Official title: Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Lead sponsor: Neuspera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
* Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
* Subject was in good health in the opinion of the investigator
* Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
* Subject was minimum of 18 years and maximum of 65 years of age

Exclusion Criteria:

- Subject had any of the contraindications for the InterStim system or InterStim II system

Primary outcomes:
measure: Sacral Nerve Response measured by observed bellow response and big toe flexion
timeFrame: Procedure
measure: AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Gommert A. van Koeveringe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04489680: Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
Official title: Educational Impact and Development of a Novel Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate Lip
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

Detailed description: Background: Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Methods: Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

Eligibility criteria: Inclusion Criteria:

* Plastic Surgery Training Residents

Exclusion Criteria:

-

Primary outcomes:
measure: Cleft lip palate surgical knowledge
timeFrame: Day 1
measure: Cleft lip palate surgical confidence
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas Hospital Plastic Surgery
Study officials:
affiliation: Birmingham Children's Hospital
name: Kezia Echlin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06749080: ASSIST 2.0: a Reablement Program for Healthy Ageing
Official title: ASSIST 2.0: a Reablement Program for Healthy Ageing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reablement
Frailty
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2024-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to continue to develop, implement, and evaluate a unique reablement service, ASSIST 2.0. The project will determine the differences in the reablement service (ASSIST 2.0) compared to regular home care in terms of older adults' performance in daily activities, self-efficacy, perceived health, quality of life, frailty and perceived person-centered approach.

The research question is: Can older adults receiving ASSIST 2.0 improve their performance and satisfaction in daily life activities, experience a higher level of self-efficacy, perceived health, quality of life and a person-centered approach?

The ASSIST project involves older adults receiving home care, home care assistants, occupational and physical therapists. ASSIST 2.0 reablement consists of the following components:

* an intervention aimed at older adults to help them perform daily activities they need and want to do. This will be achieved through optimal support from home care staff,
* an on-line education provided by the researchers for all staff in the art and science of reablement,
* training and support through mentorship and coaching provided by occupational and physical therapists for home care staff to ensure the proper delivery of reablement.


Eligibility criteria: Inclusion criteria:

* Homecare has been granted
* The person can describe an ordinary day and what they have problems with doing
* 65 years of age or over

Exclusion criteria:

• The person has palliative care

Primary outcomes:
measure: The improvement of performance and/or satisfaction in prioritized everyday activities after the end of the reablement intervention, 6 and 12 months post baseline.
timeFrame: Measurements will be at baseline, two weeks post base line, at the end of the intervention (6-12 weeks post baseline), 6 and 12 months post baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet
city: Uppsala
country: Sweden
facility: Uppsala Kommun
Study officials:
affiliation: Karolinska Institutet
name: Susanne Guidetti, PhD, Professor
role: STUDY_DIRECTOR
References:
citation: Assander S, Bergstrom A, Eriksson C, Meijer S, Guidetti S. ASSIST: a reablement program for older adults in Sweden - a feasibility study. BMC Geriatr. 2022 Jul 26;22(1):618. doi: 10.1186/s12877-022-03185-2.
Clinical trial NCT03229980: Pediatric Myocardial Protection With Potassium Cardioplegia
Official title: Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardioplegia
Keywords: myocardial protection
potassium cardioplegia
tropinin
Custodiol
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 87
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation

Detailed description: After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups

Eligibility criteria: Inclusion Criteria

* Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.
* Hemodynamic stability.

Exclusion Criteria:

* Previous cardiac surgery.
* Urgent or emergent cases.
* Any known allergies to components of either cardioplegia solutions.

Primary outcomes:
measure: Cardiac rhythm on return
timeFrame: within the first 24 hours
Secondary outcomes:
measure: The inotropic score
timeFrame: within one month
measure: Cardiac dysrhythmias
timeFrame: within the first week
measure: blood pressure
timeFrame: within the first 24 hours
measure: transthoracic echocardiography (TTE) changes
timeFrame: within the first week
measure: Troponin I levels
timeFrame: within the first 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate profossor of anesthesiology
name: Sayed k Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06885580: Digital Media Privacy Literacy Training
Official title: The Effects of Digital Media Privacy Literacy Education on Children's Autonomy, Decision-making and Privacy Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Student
Digital Health Literacy
Autonomy
Keywords: children
digital privacy literacy
autonomy
decision making
privacy awareness
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Scientific Research Fund of Atatürk University
First posted: 2025-03-20
Enrollment: 184
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students will be assigned to 2 groups: experimental and control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this randomized controlled experimental study is to evaluate the effects of digital privacy literacy education on children's autonomy, decision-making and privacy awareness.The hypotheses of the study are as follows; H1a: Digital privacy literacy education has an effect on children's autonomy. H1b: Digital privacy literacy education has an effect on children's decision-making.

H1c: Digital privacy literacy education has an effect on children's privacy awareness.

Detailed description: The research will be conducted with 4th grade students (9-12 years old) who are receiving education in a primary school affiliated to Ağrı Provincial Directorate of National Education and who meet the inclusion criteria. Students will be divided into 2 groups as experimental and control groups by simple random method. Digital environment privacy literacy training will be provided to the experimental group, while no training will be provided to the control group. Data will be collected using "Child Information Form", "Autonomy Survey" and "Primary School Students' Privacy Consciousness Scale".

Eligibility criteria: Inclusion Criteria

* Being in the 4th grade of primary school
* Not being an inclusive student
* Parent's written consent to participate in the research
* Child's verbal consent to participate in the research

Exclusion Criteria

* Child/parent wants to leave the study at any stage
* Child does not attend the training sessions 2 or more times
* Child does not complete at least one of the pre-test and post-test data collection tools

Primary outcomes:
measure: Autonomy Survey
timeFrame: 1 weeks
measure: Privacy Awareness Scale of Primary School Students
timeFrame: 1 weeks
measure: Introductory Information Form
timeFrame: 1 weeks
Secondary outcomes:
measure: Autonomy survey
timeFrame: 12 weeks
measure: Privacy Awareness Scale of Primary School Students
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Ataturk University
name: Türkan Kadiroğlu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02707380: The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Official title: The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes (T2DM)
Cardiovascular Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to investigate the effect of a structured resistance training program on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type 2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator will compare the experimental group receiving resistance training to a control group made of patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise modalities during their sessions, which is the current standard of care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis with T2DM and have been accepted for a standard outpatient cardiac rehabilitation program
* Cognitively able to comprehend the information presented in the program
* Cognitively able to give informed consent to participate in this study

Exclusion Criteria:

* Patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions.

Primary outcomes:
measure: Comparison of Stress measured by change in heart rate
timeFrame: Baseline, One Year, 2 Years
measure: Leg strength measured by assessing maximum weight subject can press one time on a leg press machine
timeFrame: up to 2 years
measure: Paired T-test to compare test-retest Perceived exertion
timeFrame: up to 2 years
measure: Paired T-test to compare test-retest Perceived dyspnea
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Francois Haas, MD
role: PRINCIPAL_INVESTIGATOR
References: