louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02024763: Educational Program and Schoolchildren's Energy Expenditure
Official title: Effect of an Educational Program on Schoolchildren's Energy Expenditure During Physical Education Classes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Energy Expenditure
Physical Education
Children
Randomized Controlled Trial
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 352
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in São Paulo, Brazil.

Detailed description: This study is a School-based Randomized Controlled Trial. Three-step cluster sampling was used for subject selection. In the first step, 8 schools in the Vila Mariana district - São Paulo were selected and assigned randomly to physical activity intervention (3 schools) or control condition (5 schools). In the second step, all 48 classes from the 1st and 2nd grades were selected. In the third step, 352 children were randomly selected compose the observational group. In both groups, questionnaire data and SOFIT's observation were collected two times: "pre" (immediately before the intervention), and "post" (immediately after the intervention), with a six weeks interval between them. No educational intervention was taken place in the control schools while the project was running. Afterwards control schools received training.

Eligibility criteria: Inclusion Criteria:

* children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools in Vila Mariana - Sao Paulo.

Exclusion Criteria:

* Not have both observations.

Primary outcomes:
measure: Change in children's Physical Activity Level / Energy Expenditure after an Educational Intervention for classroom teachers.
timeFrame: Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval.
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Jose Augusto AC Taddei, MD, Dr PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01789463: Physiotherapy and Capsulitis
Official title: Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthritis
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.


Eligibility criteria: Inclusion Criteria:

* Primary idiopathic phase 2 capsulitis
* Diagnosis of capsulitis confirmed by shoulder dilatation
* Patients between 18 and 70 years of age
* Exclusion Criteria:
* Secondary capsulitis
* Shoulder pain of other etiology
* Cognitive disorders
* Patients less than 18 years, and more than 70 years of age

Primary outcomes:
measure: Function of the shoulder joint (Score de Constant)
timeFrame: 12 months post shoulder dilatation
Secondary outcomes:
measure: Pain Visual Analogue Scale (at evening, rest, and at movement)
timeFrame: 12 months post shoulder dilatation
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Hôpital FOCH 40, rue Worth 92150 Suresnes
name: Bernard BOISAUBERT, MD
role: STUDY_CHAIR
affiliation: IMM - 42, boulevard Jourdan 75014 Paris
name: Louis FRANCESCHI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557463: Testing a Novel Dairy Protein to Counteract Immunosenescence
Official title: Use of UV-treated Milk Powder to Increase Vaccine Efficacy in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunodeficiency
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled, randomized, double blind pilot study
Primary purpose: TREATMENT

Brief summary: Aging populations experience a decline in adaptive immune system function also known as immunosenesence. Nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population. A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response. Our objective was to examine the immune stimulating effects of dairy protein subjected to ultraviolet radiation (UV-C) radiation treatment process instead of pasteurization. Participants were 21 healthy individuals over 60 years of age who consumed 6 g of the dairy protein or a comparison, soy isoflavone protein, twice a day for eight weeks. DTaP vaccine administered at week 4. Non-parametric t-tests revealed a significant increase in Tetanus antibodies in the dairy group compared to the soy group at week 8. These findings suggest additional benefits of UV-C treated unheated dairy protein as a solution to counteract immunosenescence, but warrant further study in elderly and other populations that might benefit from immune system stimulation.


Eligibility criteria: Inclusion criteria included participants be more than 60 years of age. Volunteers underwent a physical examination and health assessment by a physician to ensure the absence of exclusion criteria which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (New York Heart Association classes III-IV). Having received a DTaP vaccine within the last five years was an exclusion criteria for the study, but patient records were incomplete for many volunteers on this aspect. Therefore, volunteers with an initial Tetanus antibody level above 3 IU/mL were excluded from the study results as the volunteer was assumed to have had the DTaP vaccine within the last 5 years.

Primary outcomes:
measure: Immune response to vaccine
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00293163: A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Wrinkles
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Inamed Aesthetics
First posted: 2006-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.


Eligibility criteria: Inclusion Criteria:

* bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

* pregnant/lactating women
* patients who previously received permanent facial implants or using over-the-counter products

Primary outcomes:
measure: no difference in keloid and scar formation
measure: pigmentation disorders
measure: hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California
state: California
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Philadelphia
country: United States
facility: Society Hill Dermatology
state: Pennsylvania
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05504486: Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Official title: A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Major Depressive Disorder (MDD)
Keywords: Major depressive disorder (MDD)
symptoms of anxiety
fMRI
brain networks
modularity
community structure
brexpiprazole
default mode network
salience network
central executive network
functional brain connectivity
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2022-08-17
Enrollment: 0
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 year of age
* Major Depressive Disorder (MDD) with symptoms of anxiety
* Stable treatment with less than 50% improvement

Exclusion Criteria:

* Contraindicated to perform fMRI scan
* Previous exposure to brexpiprazole

Primary outcomes:
measure: Change in fMRI resting-state salience network community structure from baseline to post-treatment
timeFrame: Week 6
Secondary outcomes:
measure: Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
timeFrame: Week 6
measure: Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
timeFrame: Week 6
measure: Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01285986: Scandinavian Miller Collar Study
Official title: Scandinavian Miller Collar Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Keywords: Graft patency
Limb salvage
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Sunderbyn Hospital
name: Borås Lasarett
name: Eskilstuna Lasarettet
name: Falu Lasarett Röntgen
name: Sahlgrenska University Hospital
name: Lasarett Gävle
name: Helsingborgs Hospital
name: Kalmar County Hospital
name: Karlstad Central Hospital
name: Kristiansund Hospital
name: Lund University Hospital
name: Malmö University
name: Department of Surgery, Lasarettet, Motala, Sweden
name: Department of Surgery, Lasarettet, Mölndal, Sweden
name: Department of Surgery, Lasarettet, Norrköping, Sweden
name: Department of Surgery, Lasarettet, Nyköping, Sweden
name: Department of Surgery, Lasarettet, Skellefteå, Sweden
name: Department of Surgery, Kärnsjukhuset, Skövde, Sweden
name: Department of Surgery, S:t Görans Sjukhus, Stockholm, Sweden
name: Department of Surgery, Södersjukhuset, Stockholm, Sweden
name: Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Sweden
name: Uppsala University Hospital
name: Västervik Hospital
name: Region Västmanland
name: Department of Surgery, Lasarettet, Växjö, Sweden
name: Department of Surgery, Lasarettet, Örebro, Sweden
name: Department of Surgery, Lasarettet, Östersund, Sweden
name: Department of Vascular Surgery, Sykehuset, Kolding, Denmark
name: Rigshospitalet, Denmark
name: Aalborg University Hospital
First posted: 2011-01-28
Enrollment: 352
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage


Eligibility criteria: Inclusion Criteria:

* Critical limb ischemia
* Need for bypass surgery

Exclusion Criteria:

* Can not participate in follow-up
* Has suitable saphenous vein

Primary outcomes:
measure: Primary graft patency
timeFrame: Up to five years
Secondary outcomes:
measure: Secondary Patency
timeFrame: Up to five years
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of CardioVascular Surgery, University Hospital
Study officials:
affiliation: Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
name: Fredrik BG Lundgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975386: Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods
Official title: Echocardiographic Investigation of the Cardiac Effects of Different Regional Anesthesia Methods Used in Intertrochanteric Femoral Fracture Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femur Fracture
Spinal Anesthesia
Lumbar Plexus Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-23
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Nerve blocks applied with neuraxial anesthesia and ultrasonography are used for many operations today. Neuraxial blocks cause varying degrees of decrease in the blood pressure level of the patients. Peripheral blocks may be preferred to avoid the cardiac effects of the neuraxial anesthesia method.

Detailed description: The hypothesis of this study was that spinal anesthesia applied in intertrochanteric femoral fracture operations caused hypotension by lowering the cardiac ejection fraction.

In our study, The investigators aimed to find out the effect of different regional anesthesia methods on the cardiac function of the patients by echocardiography.

Eligibility criteria: Inclusion Criteria:

* 60-100 years old
* American Society of Anesthesiologist Score I-IV

Exclusion Criteria:

* Local anesthetic allergy
* Bleeding disorder
* Mental disorder
* Allergy to drugs used
* Body mass index above 30

Primary outcomes:
measure: Ejection fraction
timeFrame: peroperative
Secondary outcomes:
measure: intraoperative blood pressure monitoring
timeFrame: peroperative
measure: cardiac diastolic dysfunction
timeFrame: peroperative
measure: Entropy
timeFrame: peroperative
measure: sedative drug
timeFrame: intraoperative
measure: ramsey sedation scale
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Durdu M.D Kahraman Yıldız
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164486: First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Official title: First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Carcinoma
Colorectal Carcinoma
Lung Carcinoma
Metastatic Malignant Neoplasm in the Breast
Metastatic Malignant Neoplasm in the Colon
Metastatic Malignant Neoplasm in the Lung
Metastatic Malignant Neoplasm in the Rectum
Pancreatic Carcinoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-23
Enrollment: 27
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: This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the safety, biodistribution and dosimetric properties of 18F-alphavbeta6-binding peptide (BP) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression.

OUTLINE:

Patients receive 18F-alphavbeta6-BP intravenously (IV) and then undergo positron emission tomography (PET) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.

After completion of study, patients are followed up for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
* Will sign the Institutional Review Board (IRB)-approved consent form
* Able to remain motionless for up to 30-60 minutes per scan

Exclusion Criteria:

* Creatinine \> 2 x upper limit of normal
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 x upper limit of normal
* Life expectancy \< 3 months (mo)
* Women who are pregnant or breast-feeding
* Patients who cannot undergo PET/compute tomography (CT) scanning
* Lack of availability for follow-up assessments
* Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment

Primary outcomes:
measure: Assessment of safe administration of 18F-αvβ6-BP
timeFrame: Up to 6 months
Secondary outcomes:
measure: Measurement of 18F-αvβ6-BP accumulation in tumors
timeFrame: Up to 6 months
measure: Level of αvβ6-BP expression in tumors
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Julie Sutcliffe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06973486: Causes of Spinal Failure in Cesarean Section
Official title: The Effects of Social, Emotional and Attitudinal Dynamics on Spinal Anesthesia Outcomes in Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Causes of Spinal Failure
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 128
Sex: FEMALE
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: Pregnant women over 18 years of age receiving spinal anesthesia

Brief summary: The main purpose of this research is to determine the causes of spinal anesthesia failures during cesarean section due to social, emotional and attitude factors towards surgery and to use this information to improve anesthesia practice.


Eligibility criteria: Inclusion Criteria:

* spinal anesthesia for term pregnancy and cesarean section
* age ≥ 18
* knowing the gestational week when participating in the study
* answering all research questions
* using the internet and social media tools

Exclusion Criteria:

* mental and physical disability
* diagnosis and treatment for psychiatric disorders
* clinically significant physical health problemı

Primary outcomes:
measure: spinal anesthesia success rate
timeFrame: 20 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.