louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03277027: Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Official title: Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Quality of Life
Physical Activity
Physical Disability
Parenting
Sleep Disorder
Keywords: cerebral palsy
Health-Related Quality Of Life
Physical Activity
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is assessing physical activity, the quality of sleep and health related quality of life in children with cerebral palsy, and parenting stress of caregivers of the children with cerebral palsy in Korea.

Detailed description: Monitor the physical activity, health related quality of life, parenting stress according to GMFCS level in children with cerebral palsy in Korea.

1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.
2. Health related quality of life is checked by parents withChild Health Questionnaire Parent Form 50 (CHQ-PF50).
3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy, 4-19 years old

Exclusion Criteria:

* Patients with progressive brain lesions, tumors, leukodystrophies, etc.
* Children with mitochondrial myopathy
* Some diseases that are known to progress, Rett syndrome, etc.

Primary outcomes:
measure: Physical activity
timeFrame: Monitored for a week
Secondary outcomes:
measure: health related quality of life
timeFrame: Once (cross sectional)
measure: Parenting stress
timeFrame: Once (cross sectional)
measure: Quality of sleep
timeFrame: Monitored for a week
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's hospital
Study officials:
affiliation: St. Vincent's hospital, The Catholic University of Korea
name: Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06763627: The Effectiveness of Gamification vs. Traditional Teaching in Undergraduate Medical Education
Official title: The Effectiveness of Gamification-Based Learning Versus Traditional Classroom Teaching in Acute Cholecystitis and Pancreatitis Education Among Medical Students: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medical Education
Gamification
Keywords: Gamification
Boardgame
Medical Education
Medical Student
General Surgery
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the effectiveness of a gamification-based learning method (board game) versus traditional teaching (lecture) in enhancing the knowledge of acute cholecystitis and pancreatitis among medical students in the general surgery ward at Rasoul Akram Hospital. This study will be conducted as an extra-curricular program, using pre- and post-tests to determine the effectiveness of gamification in general surgery learning within undergraduate medical education. The board game will incorporate innovative educational strategies to engage students in learning about acute cholecystitis and pancreatitis


Eligibility criteria: Inclusion Criteria:

* Medical students in their clinical externship in the general surgery ward.
* Willingness to participate voluntarily.

Exclusion Criteria:

* Previous knowledge or exposure to acute cholecystitis and pancreatitis.
* Lack of consent or inability to attend the sessions.
* Medical students not currently assigned to general surgery clinical rotations.

Primary outcomes:
measure: Change in knowledge of acute cholecystitis and pancreatitis
timeFrame: Baseline (pre-intervention) and immediately after the intervention
Secondary outcomes:
measure: Retention of knowledge on acute cholecystitis and pancreatitis
timeFrame: 6 weeks after the intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran University of Medical Sciences
Study officials:
References:
Clinical trial NCT07001527: Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial
Official title: Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chlorhexidine
Keywords: chlorhexidine
Lead sponsor: Hospital Universitario Evangelico de Curitiba
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous catheters (CVC), using dressings impregnated or not with chlorhexidine/vancomycin. We believe this study is important as it aims to evaluate a new dressing method intended to reduce bloodstream-related infections.


Eligibility criteria: IInclusion criteria included: age over 18 years, admitted to the ICU, need for a CVC placed in the ICU by the trained team, use of the CVC for a period exceeding 72 hours, and intact skin in the area of contact with the dressing. CVC inserted outside the ICU and need for two CVCs in the same patient simultaneously were exclusion criteria. A subsequent CVC could not be randomized. Other infections were not excluded during the evaluation. Only short-term CVC were evaluated (long-term and hemodialysis were excluded).

Primary outcomes:
measure: Infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: PUCPR
state: PR
Study officials:
References:
Clinical trial NCT05918627: A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Examine the Safety, Tolerability and Pharmacokinetic Profile of Single Oral Doses of SLx-2119 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Disorder (Healthy Volunteer)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.

Detailed description: Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

* Healthy participants between the ages of 18 and 55 years, inclusive.
* Able to provide written informed consent prior to the performance of any study specific procedures.
* Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:
* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
* Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with adverse events and serious adverse events
timeFrame: Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.
Secondary outcomes:
measure: Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
timeFrame: Predose and multiple timepoints up to 24 hours postdose on Day 1
measure: tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
timeFrame: Predose and multiple timepoints up to 24 hours postdose on Day 1
measure: AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
timeFrame: Predose and multiple timepoints up to 24 hours postdose on Day 1
measure: AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
timeFrame: Predose and multiple timepoints up to 24 hours postdose on Day 1
measure: t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
timeFrame: Predose and multiple timepoints up to 24 hours postdose on Day 1
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Investigational site
state: Maryland
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01155427: Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)
Official title: A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical trial enrollees

Brief summary: The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Detailed description: Systematic review of prospective clinical trials

Eligibility criteria: Inclusion Criteria:

* Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
* Age 16 years or older
* No post-transplant patients
* RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
* At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
* Study arms must include at least 10 patients
* Follow-up of at least 48 weeks
* Published results available in English language

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Viral load
measure: Histological improvement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04270227: Does Physical Activity Level Depend on Exercise Perception and Body Awareness
Official title: Does Physical Activity Level Depend on Exercise Perception and Body Awareness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young healthy adults

Brief summary: Healthy volunteers between the ages of 18-25 who will not have any problems preventing physical activity will be included among the university students. The criteria for not being included in the study were determined as being diagnosed with any disease that impedes physical activity and not wanting to participate in the study. Participation in the investigator's study is completely voluntary. Individuals who do not wish to participate in the study will be excluded. Cases with missing survey and demographic information will be excluded from the study. The planned study is a cross-sectional study.


Eligibility criteria: Inclusion Criteria:

* Not having any problems preventing physical activity
* No identified chronic disease
* Being between the ages of 18-25

Exclusion Criteria:

-Not want to participate in the study

Primary outcomes:
measure: Body awareness scale (Body awareness questionnaire-Turkish)
timeFrame: 15 minutes
Secondary outcomes:
measure: Exercise Benefits/Barriers Scale
timeFrame: 15 minutes
measure: International Physical Activity Questionnaire Short Form
timeFrame: 15 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Esra Pehli̇van
state: Üsküdar
Study officials:
References:
Clinical trial NCT04488627: Reliability of Ultrasound Examination of the Inferior Caval Vein
Official title: Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transthoracic Echocardiography
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
First posted: 2020-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult intensive care unit patients on mechanical ventilation.

Brief summary: The purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.

Detailed description: A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views:

1. Subcostal view on the inferior caval vein in the long axis,
2. subcostal view on the inferior caval vein in the short axis,
3. right lateral view on the inferior caval vein in the long axis,
4. right lateral view on the inferior caval vein in the short axis.

Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.

Eligibility criteria: Inclusion Criteria:

* Inpatients
* Patients on mechanical ventilation indicated for transthoracic echocardiographic examination

Exclusion Criteria:

* Age \<18 years
* Insufficient imaging quality
* Refusal of echocardiographic examination by patient

Primary outcomes:
measure: Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital Usti nad Labem
Study officials:
affiliation: Masaryk Hospital Usti nad Labem
name: Roman Skulec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00752427: 24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
Official title: R076477-SCH-702: a 24 Week Open-Label Extension to R076477-SCH-302
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia: paliperidone
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

Detailed description: The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (\>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy.

Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally

Eligibility criteria: Inclusion Criteria:

* Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase

Exclusion Criteria:

* Significant and/or unstable systemic illnesses
* Allergy or hypersensitivity to risperidone or paliperidone
* Significant risk of suicidal or violent behavior
* Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant

Primary outcomes:
measure: Long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia
Secondary outcomes:
measure: Assessment of long-term efficacy of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, .
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05003427: 68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Official title: 68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Oral Carcinoma
Keywords: PET/CT
FAPI
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Detailed description: Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Eligibility criteria: Inclusion Criteria:

* patients in suspicion of oral carcinoma,
* 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
* being able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* claustrophobia,
* pregnancy,
* breastfeeding,
* kidney or liver failure,
* inability to fulfill the study.

Primary outcomes:
measure: Diagnostic performance1
timeFrame: 1 year
measure: Diagnostic performance2
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT02166827: Effects of a NeuroAD System, for the Treatment of Alzheimer Disease
Official title: Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: TMS
Cognitive Stimulation
NeuroAD
Lead sponsor: Neuronix Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term efficacy of the NeuroAD system

Detailed description: To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function

Eligibility criteria: Main Inclusion Criteria:

1. Male or female age 60-90 years
2. Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria
3. MMSE score 18 to 26
4. Physical clearance for study participation as evaluated by the clinician
5. Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
6. Informed consent by the patient or by legally authorized person if appointed

Main Exclusion Criteria:

1. CDR 0, 0.5 or 3
2. Severe agitation
3. Mental retardation
4. History of Epileptic Seizures or Epilepsy
5. Contraindication for performing MRI scanning
6. Contraindication for receiving TMS treatment according to a TMS questionnaire
7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
8. Cardiac pacemakers
9. Implanted medication pumps
10. Intracardiac lines
11. Significant heart disease
12. Currently taking medication that lower the seizure threshold

Primary outcomes:
measure: Efficacy
timeFrame: 3 Months
Secondary outcomes:
measure: Efficacy
timeFrame: 7 weeks
measure: Efficacy
timeFrame: 6 Months
measure: Efficacy
timeFrame: 9 Months
Other outcomes:
measure: Safety
timeFrame: 9 Months
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek
Study officials:
References: