louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01597076: Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxidative Stress
Quality of Life
Metabolic Syndrome
Keywords: Morinda citrifolia
noni
advanced glycation end products
oxidative stress
quality of life
metabolic syndrome
safety
Lead sponsor: Tahitian Noni International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Indonesia University
First posted: 2012-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.


Eligibility criteria: Inclusion Criteria:

* Males and females age 25 to 60 years.
* Overweight or obese, defined as BMI 23.0 to 39.9 kg/m2.
* Impaired fasting glucose, defined as fasting blood glucose 100 to 125 mg/dl.
* Prehypertension or Grade 1 hypertension, defined as systolic blood pressure 120-159 mm Hg AND diastolic BP 80-99 mm Hg.
* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
* Consent to the study and willing to comply with study procedures.

Exclusion Criteria:

* Prescription medication use for hypertension, high cholesterol, diabetes, heart disease, cancer, liver disease, or AIDS/HIV 2.
* Intake of foods and/or dietary supplements that may confound study outcomes including any use of a noni-based dietary supplement in the last month.
* Regular use (\> 3 times per week over the past month) of any dietary supplement that contains "super fruits" or high antioxidant concentrations.
* Regular use (\> 3 times per week over the past month) of any dietary supplement intended to alter or regulate blood glucose levels.
* Any medical conditions or diseases that may affect subject safety or confound study results (in the opinion of the investigator).
* Pregnant or lactating female.
* History of alcohol, drug, or medication abuse.
* Current heavy smokers (1 or more packs/day).
* Allergies to any ingredient in the investigational products.
* Participation in another study with any investigational product.

Primary outcomes:
measure: skin autofluorescence (akin advanced glycation end products)
timeFrame: Baseline and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Department of Nutrition, Faculty of Medicine, University of Indonesia
Study officials:
affiliation: Indonesia University
name: Samuel Oetoro, dr MS SpGK
role: PRINCIPAL_INVESTIGATOR
affiliation: Morinda Inc.
name: Claude J Jensen, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01819376: Use of Facebook as a Motivating Factor in a Weight-reduction Program for Obese and Overweight Adolescents
Official title: Use of Facebook as a Motivating Factor in a Weight-reduction Program for Obese and Overweight Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Adolescents
Teenagers
Facebook
Social Networks
Lead sponsor: TecSalud Investigación Clínica
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if Facebook can be used as a motivating factor for obese or overweight adolescents in a weight-reduction program.

Detailed description: This study is a randomized controlled trial. There will be two randomly assigned groups of obese or overweight adolescents (WHO definition). Both groups will be enrolled in a 12 week weight reduction program which includes personal nutritional evaluation and food plan and exercise routine. Follow-up appointments will be held every 3 weeks. One group will be encouraged to update their Facebook status at least once a day, regarding their healthy lifestyle changes (exercise routine, healthy food choice, "checking-in" at the wellness center, kilograms lost, etc). The control group will be asked not to share information about their program on Facebook for 12 weeks. Facebook follow-up will be held by the investigators on the study's Facebook account. Teenagers will be thoroughly explained on how to set the account to a limited profile if they want to. At the end of the program both groups will be compared regarding weight loss and mean BMI.

Eligibility criteria: Inclusion Criteria:

* Adolescents between 13 and 19 years old.
* Obese or overweight according to the IOTF.
* No physical or medical impediment for performing physical activity.
* No risk for eating disorders (SCOFF questionnaire).
* Report less than 20 minutes of physical activity per day.
* Have an active Facebook account and use it more than 20 minutes per day.
* Low-risk in the Gatehouse Bullying Scale.

Exclusion Criteria:

* Physical or medical impediment for performing physical activity.
* Answer "yes" at least twice on the SCOFF questionnaire.
* Report more than 20 minutes of exercise per day.
* Not having an active Facebook account or using it less than 20 minutes per day.
* "High Risk" on the Gatehouse Bullying Scale.

Primary outcomes:
measure: BMI
timeFrame: 12 weeks
Secondary outcomes:
measure: Positive Feedback
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Instituto de Bienestar Integral
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT04129476: Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Official title: Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Partum Depression
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.


Eligibility criteria: Inclusion Criteria:

* Informed consent to participate in the research
* Gestational age 30-35 weeks
* Be literate
* No history of depression or mental illness in the past
* Healthy fetus on ultrasound

Exclusion Criteria:

* Having a preterm birth
* Refusal to attend training sessions

Primary outcomes:
measure: Postpartum Depression
timeFrame: Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week
Secondary outcomes:
measure: Predisposing, reinforcing and enabling factors inventory
timeFrame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
measure: General health questionnaire (GHQ)
timeFrame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Other outcomes:
Locations:
city: Gonabad
country: Iran, Islamic Republic of
facility: Gonabad University of Medical Science
state: Khorasan Razavi
Study officials:
affiliation: Gonabad University of Medical Science
name: Baloochi
role: STUDY_CHAIR
References:
Clinical trial NCT03131076: Quality of Life Assessment in Patients Who Are Under Surveillance for IPMN
Official title: Intraduktaalisen Papillaarisen Musinoosisen Neoplasian Vuoksi Seurannassa Olevien Potilaiden elämänlaatu
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IPMN
Quality of Life
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients under IPMN follow up

Brief summary: Over 500 patients were participating in the IPMN follow up between september 2014 and august 2016 at the Helsinki University Hospital. In this study we are going to determine the effects of the IPMN surveillance on the quality of life and anxiety levels of the patients.

Detailed description: Intraductal papillary mucinous neoplasm (IPMN) is a cystic neoplasm of the pancreas. The incidence of the tumors has increased during the last years. Some of the IPMN-tumors develop over time increasing dysplasia and at the end IPMN associated carcinoma. All IPMN-patients are kept under surveillance because of the cancer risk. This follow up can last decades and includes MRI and blood samples every 6 to 12 months. This is very expensive and the effects on the patients quality of life have not been studied before to our knowledge.

This study determines the effects of the surveillance on the patients quality of life and anxiety levels. The study will be conducted by 15D- quality of life -questionnaire and state-trait anxiety inventory (STAI) -questionaire. Both will be send to the patients before a IPMN follow up MRI and 3 months later. It is anticipated that the anxiety and the effect on the quality of life would be the highest right before the MRI and would normalize a few months after the MRI.

Eligibility criteria: Inclusion Criteria:

* all patients under IPMN surveillance

Exclusion Criteria:

* no exclusion criteria, all patients under IPMN surveillance are included

Primary outcomes:
measure: Change in the quality of life and anxiety
timeFrame: Before and 3 months after IPMN follow up MRI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki Universtity Hospital
name: Heini Nieminen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165576: Child-centered Communication and Anesthesia Use for MRI
Official title: The Influence of Child-centered Communication on Children's Anxiety and Use of Anesthesia for MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Problem of Child
Anxiety
Keywords: patient-centered communication
children
MRI
anesthesia
toy simulation
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Centro de Investigação em Tecnologias e Serviços de Saúde
name: Rede de Investigação em Saúde
First posted: 2021-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: The goal of this project is to study the influence of child-centered communication on children's anxiety, satisfaction and the use of anesthesia for MRI

Detailed description: This study seeks to inspect the influence of a child-centered communication (CCC) on anesthesia use in magnetic resonance imaging (MRI) exams among four- to 10-year-old children. Children's levels of anxiety and satisfaction with the interaction also are assessed. Children are divided into three groups by order of arrival. Group 1 receives routine information about the MRI and simulates it with an MRI toy (EG1). Group 2 simulates the exam with the toy and receives the CCC. These two groups are compared with a third group of children who had received only the routine information about the exam and who served as a comparison group (CG).

Eligibility criteria: Inclusion Criteria:

* Ages between four and 10 years old
* Having a medical request for the MRI in the hospital
* The MRI performed for the first time

Exclusion Criteria:

* Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
* Having any intra-body devices that impeded performance of the MRI exam

Primary outcomes:
measure: Anesthesia count
timeFrame: 30 minutes (after the Magnetic Resonance Imaging)
Secondary outcomes:
measure: Change in self-reported anxiety
timeFrame: 20 minutes (before and after the child's preparation)
measure: Change in heart rate frequency
timeFrame: 20 minutes (before and after the child's preparation)
Other outcomes:
measure: Satisfaction measurement
timeFrame: 20 minutes (after child preparation to do the Magnetic Resonance Imaging)
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
city: Porto
country: Portugal
facility: Faculty of Medicine of the University of Porto
Study officials:
affiliation: Universidade do Porto
name: Irene P Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813176: One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers
Official title: One-Lung Ventilation in Morbidly Obese Patients:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
One-Lung Ventilation
Anesthesia
Thoracic
One-lung ventilation in the morbidly obese patient
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.

Detailed description: The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.

Eligibility criteria: Inclusion Criteria:

1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
2. Subject is \>18 years of age.
3. Subject's BMI \> 35.

Exclusion Criteria:

1. Subject \< 18 years of age.
2. Subject's BMI \< 35.

Primary outcomes:
measure: Time Taken for Endotracheal Tube Placement Procedure.
timeFrame: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.
measure: Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
timeFrame: This data measure was occurred during surgery.
Secondary outcomes:
measure: Effectiveness of Lung Collapse
timeFrame: This measure occured during surgery just after intubation.
measure: Time Required to Collapse the Lung
timeFrame: This measurement occurred during surgery.
measure: Number of Participants With Successful Reinflation
timeFrame: This occurred during surgery.
measure: Mean Intraoperative Oxygenation During One-lung Ventilation
timeFrame: This measure occured during surgery.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Iowa Health Care
name: Javier H Campos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004276: Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System
Official title: A Cluster Randomized Controlled Pilot Trial of the Effect of a New, Improved Smoking Cessation Management Module, Compared With Use of the Standard Version of Such a Management Module, on Smoking Counselling Initiation and Continuation Rates in Primary Care Practices Currently Using P-PROMPT Chronic Disease Management System in Ontario
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery of Health Care
Smoking Cessation
Keywords: primary health care
delivery of health care
smoking cessation
chronic disease
disease management
pilot projects
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2009-10-29
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.


Eligibility criteria: Inclusion Criteria:

* Physician subscribers to P-PROMPT CDMS

Exclusion Criteria:

* Paper users
* Physicians expected to retire during the course of the study
* Physicians whose billing files are not set-up with DataSynch

Primary outcomes:
measure: Smoker Identifying Cards
timeFrame: 3 months post-intervention
measure: Chronic disease management system's activity log
timeFrame: monthly post-intervention
Secondary outcomes:
measure: Smoking cessation counselling billing codes from physician's remittance advice files
timeFrame: monthly post-intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: McMaster University
name: Natalie T. MacLeod, M.Sc. Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Rolf J. Sebaldt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Peter Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745576: Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
Official title: An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and verapamil.


Eligibility criteria: Inclusion criteria :

1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
2. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria :

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: blood samples
timeFrame: 7 weeks
Secondary outcomes:
measure: Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Gieres
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01706276: MASIMO Radical 7 and Laboratory Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Hepatic Surgery
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients, American Society of Anesthesiologists Physical Status Ⅰor Ⅱ, scheduled for potentially hemorrhagic major hepatic resection under general anesthesia and requiring an arterial line

Brief summary: Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin concentrations through compared with laboratory measurement during major hepatic surgery, and to determine the source of discordance between two methods.


Eligibility criteria: Inclusion Criteria:

* adult patients
* American Society of Anesthesiologists Physical Status Ⅰor Ⅱ
* scheduled for potentially hemorrhagic major hepatic resection under general anesthesia
* requiring an arterial line

Exclusion Criteria:

* coagulopathy
* hemoglobinopathy
* cardiac dysrhythmias
* arrhythmia
* intracardiac shunt
* heart valve diseases
* tinea unguium
* arterio puncture failure

Primary outcomes:
measure: Hemoglobin measurement using the Masimo device
timeFrame: 0.5h after skin incision
Secondary outcomes:
measure: Change of Hemoglobin measurement using the Masimo device
timeFrame: 1h and 3h after skin incision
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT04667676: Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Official title: Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inhalation Injury
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study designed to examine the effect of Acu-TENS applied bilaterally on Ding Chuan acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea in patients with inhalation injuries.


Eligibility criteria: Inclusion Criteria:

* Partial or full-thickness major burns
* Diagnosis of smoke inhalation based on the history of smoke exposure and chest computed tomography (CT)
* Have no systemic disease
* Body mass index less than 30.

Exclusion Criteria:

* Patients with any other pulmonary condition
* Cardiac condition
* Rib fracture
* Systemic disease
* Local infection and cigarette or tobacco use

Primary outcomes:
measure: Spirometer
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References: