louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06488079: Effectiveness of Different Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet Among Italian Consumers
Official title: Effectiveness of Front-of-Pack Nutritional Labels in Promoting Greater Adherence to the Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2024-07-05
Enrollment: 3029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if Front-of-Pack labels, namely Nutri-Score and NutrInform Battery, work to improve adherence to the Mediterranean diet among healthy Italian adult participants. It will also learn about the label's ability to increase nutritional knowledge and participant's response in terms of orthorexic behaviour. The main questions it aims to answer are:

* Does FOP nutritional labels work to guide participants' food choices towards healthier diets?
* Do they increase participants\&#39; nutritional knowledge?
* To what extent are they related to obsessive focus on healthy eating, such as orthorexia nervosa? Researchers will compare the labels to a no label condition (in which participants were only given a conventional nutrition education flyer) to see if labels work to improve healthiness in individual diets.

Participants will:

* Complete an initial questionnaire's battery
* Use the assigned FOP label every day for 1 month to orient their food choices
* Answer to final questionnaires


Eligibility criteria: Inclusion Criteria:

* limited to participants older than 18 years

Exclusion Criteria:

* people currently on a diet for religious/ethical/personal choice or medical prescription
* people with a degree or a professional expertise in the area of field, nutrition, and physical exercise
* people who know one of the interventions

Primary outcomes:
measure: Adherence to the Mediterranean diet
timeFrame: 30 days
Secondary outcomes:
measure: Nutrition Knowledge
timeFrame: 30 days
measure: Orthorexic behaviour
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University
state: Rome
Study officials:
affiliation: Sapienza University
name: Lorenzo Maria Donini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02320279: The Fetal EKG Study
Official title: The Fetal EKG Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor
Keywords: Fetal Heart Rate
Fetal EKG
FHR tracing
fetal R-waves
Lead sponsor: Mindchild Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 900
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, women in labor, and women who are admitted to labor and delivery for scheduled c-sections will form the eligible population for recruitment into our study. These women will be identified by a study staff-member who will ask on-call physicians, midwives, and nurses working on Labor and Delivery

Brief summary: The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.

Detailed description: Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis.

* Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor.
* Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval.
* Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes.
* Specific Aim 5: Collect clinical data related to medication usage and hypoxia.

Eligibility criteria: Inclusion Criteria:

* Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent
* 18 years old or older.
* Gestational age of 24-42 weeks.
* Any method of fetal heart rate monitoring.
* Pregnant women in labor as well as women who are not in labor.
* Pregnant women who are admitted to labor and delivery for scheduled c-sections.

Exclusion Criteria:

* Women unable to consent
* Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity
* Women in extremis (in severe pain, etc.)
* Women who are using the Mindchild device for clinical monitoring.

Primary outcomes:
measure: Quantitative FHR
timeFrame: During Labor
Secondary outcomes:
measure: Uterine contractions
timeFrame: During labor
Other outcomes:
Locations:
city: South Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
Study officials:
affiliation: South Shore Hospital
name: Adam Wolfberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02957279: Dendritic Cells-Derived Exosomes in Human Sepsis
Official title: A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
exosomes
dendritic cell
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were admitted to Jinling Hospital from November, 2016.

Brief summary: The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

Detailed description: This is a prospective, single-centered, clinical cohort study.

Eligibility criteria: Inclusion Criteria:

* Patients were selected with the diagnostic standard "Sepsis 3.0".
* Healthy volunteers do not have serious illness.

Exclusion Criteria:

* Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
* Patients give up treatments.
* Patients or volunteers withdrew from the study.

Primary outcomes:
measure: Amount of dendritic cell-derived exosomes
timeFrame: The first 4 hour after admission
Secondary outcomes:
measure: Compositions of microRNA in the dendritic cell-derived exosomes
timeFrame: The first 4 hour after admission
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jianan Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05188079: Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population
Official title: Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, cross-over, placebo-controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess vascular function in African Americans, Hispanic and Caucasian Americans to better understand racial differences in cardiovascular health. The investigators will further investigate the affect of Beetroot juice on the vascular function of all participants.

Detailed description: African Americans and Hispanic individuals have the highest incidence of type 2 diabetes, which increases their risk of all cardiovascular diseases. One of the hallmarks of type 2 diabetes is vascular dysfunction, caused by a lack of nitric oxide bioavailability. Vascular function and blood flow responses to exercise have been shown to improve after nitrate supplementation (beetroot juice), However, whether nitrate supplementation will improve vascular function in African American and Hispanic individuals remains unknown. The investigators will perform a randomized, placebo-controlled study in healthy African American, Hispanic and Caucasian subjects. They will be studied before and 90 minutes after consuming Beetroot juice (high nitrate supplement) or Placebo, with at least 1-week washout period between the two visits (Kenjale AA et al., J Appl Physiol 2011).

Eligibility criteria: Inclusion Criteria:

* Healthy men and women who are either Caucasian American, Hispanic, or non-Hispanic African American

Exclusion Criteria:

* Blood pressure higher than or equal to 140/90 mmHg
* BMI \> 35kg/m2
* Have a history of cardiovascular, neurological or vascular diseases
* Take prescription medications
* Are smokers
* Are pregnant

Primary outcomes:
measure: Forearm blood flow
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Flow mediated vasodilation
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT01082679: Treatment for Opioid Dependent Offenders
Official title: Treatment for Opioid Dependent Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opioid Dependence
Keywords: opioid dependent
methadone
Suboxone
buprenorphine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
First posted: 2010-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.


Eligibility criteria: Inclusion Criteria:

* diagnosis of opioid dependence
* opioid positive urine drug screen
* participation in local Drug Treatment Court or Treatment Alternative Program
* women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study

Exclusion Criteria:

* current alcohol or sedative dependence
* pregnancy
* women who are currently breast-feeding
* complex psychiatric co-morbidity (e.g. suicidality, psychosis)
* complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
* current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
* paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity

Primary outcomes:
measure: Retention rate of participants in the study
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Madison, Department of Family Medicine
name: Randy Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3.
Clinical trial NCT01558479: The Parkinson's Genetic Research Study
Official title: The Parkinson's Genetic Research Study (PaGeR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Genetics
Family Research
Hereditary Neurodegenerative Diseases
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families in which two or more people have been diagnosed with Parkinson's disease.

Brief summary: The Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching for genes that increase the risk of developing Parkinson's disease (PD) and related disorders. The study is a joint effort by neurologists and researchers across the United States and is sponsored by the National Institutes of Health. The coordinating center for PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in Seattle.

Detailed description: PaGeR is focusing on families in which two or more people have been diagnosed with PD. Past research suggests that such "multiplex" families might hold the key to the discovery of new PD genes.

To take part in PaGeR, participants will be asked to complete a questionnaire and to undergo an interview, a neurological exam, a short memory test, and a blood draw. Enrollment in the study usually takes between one and two hours. There is no cost to participate, and all study information is kept strictly confidential.

There are a number of designated sites across the country where families can enroll. However, for family members who are unable to travel to one of these sites, other arrangements can be made.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Member of a family in which there are two or more living individuals who have been diagnosed with Parkinson's disease

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/ Wesley Woods Health Center
state: Georgia
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington, VA Puget Sound Health Care System
name: Cyrus Zabetian, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212679: Effects of Intranasal Nerve Growth Factor for Traumatic Brain Injury
Official title: Pilot Study of Intranasal Nerve Growth Factor for Traumatic Brain Injury(TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: nerve growth factor
traumatic brain injury
intranasal
prognosis
neurological function
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Traumatic bain injury(TBI) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.This study will investigate the therapeutic effects of intranasal Nerve Growth Factor(NGF) in TBI.

Detailed description: Early NGF concentration in the cerebral spinal fluid(CSF)correlates significantly with the severity of head injury, and NGF upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve TBI.

However, the clinical use of NGF is difficulty associated with delivering them to the CNS because of the existing of blood-brain barrier(BBB). Intranasal delivery drug is a noninvasive and convenient novel method bypassing BBB, which results in targeting therapeutics to the CNS rapidly.

The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post TBI, continuing for 2 weeks.

Eligibility criteria: Inclusion Criteria:

Moderate to severe blunt traumatic brain injury defined as Glasgow Coma Scale(GCS) between 7 and 13.

Age 18\~65 years. Admission to Jinling Hospital between 24 to 72 hours. Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion Criteria:

Skull fracture, Cerebrospinal fluid rhinorrhea. Severe concurrent illness with life expectancy\<6 months or other serious illness which have a major impact on the outcome.

Treatment with other investigational agents in the past 4 weeks. Allergy to NGF. Primary ciliary dyskinesia, Asthma, Cystic fibrosis, Viral and bacterial infections, Diabetes mellitus.

Inability to provide informed consent. Pregnancy or breast-breeding. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.

-

Primary outcomes:
measure: improved neurological functions
timeFrame: at months 6 post-treatment
Secondary outcomes:
measure: HAMA,HAMD
timeFrame: at months 6 post-treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00229879: Rare Tumor Case Review
Official title: Rare Tumor Case Review
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intrapericardial Teratoma Tumor
Tumors
Keywords: pediatric health
rare tumor
children
cardiac
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with intrapericardial teratoma tumors

Brief summary: The purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children.

Detailed description: We excised an intrapericardial teratoma tumor out of a child approximately one month ago.

This is a very uncommon tumor overall, and even more uncommon in children. The majority of reports in the literature are single case reports

I would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children.

Eligibility criteria: Inclusion Criteria:

* Children with intrapericardial teratoma tumors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Kirk R Kanter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Paul M. Kirshbom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423279: The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC
Official title: The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Mono- and Co-cultured Endothelial and Smooth Muscle Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Disorder of Smooth Muscle
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-25
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women after normal birth

Brief summary: This research is NOT part of an interventional trial, however the investigators use umbilical cord after birth for isolating endothelial and smooth muscle cells for academic research.

Detailed description: Isolation and culturing of endothelial and smooth muscle muscles for academic research

Eligibility criteria: Inclusion Criteria:

* normal pregnancy

Exclusion Criteria:

-

Primary outcomes:
measure: The effect of a Diabetic- and a Kidney-like environment on gene and protein expression in mono- and co-cultured endothelial and smooth muscle cells
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Laboratory of Renal Physiology, Meir Medical Center ,
Study officials:
affiliation: Nephrology dept. Meir Medical Center, Kfar Saba , Israel
name: Sydney Benchetrit, MD
role: STUDY_DIRECTOR
References:
citation: Zitman-Gal T, Green J, Pasmanik-Chor M, Oron-Karni V, Bernheim J. Endothelial pro-atherosclerotic response to extracellular diabetic-like environment: possible role of thioredoxin-interacting protein. Nephrol Dial Transplant. 2010 Jul;25(7):2141-9. doi: 10.1093/ndt/gfp768. Epub 2010 Jan 19.
citation: Talmor-Barkan Y, Bernheim J, Green J, Benchetrit S, Rashid G. Calcitriol counteracts endothelial cell pro-inflammatory processes in a chronic kidney disease-like environment. J Steroid Biochem Mol Biol. 2011 Mar;124(1-2):19-24. doi: 10.1016/j.jsbmb.2011.01.001. Epub 2011 Jan 12.
citation: Talmor-Barkan Y, Rashid G, Weintal I, Green J, Bernheim J, Benchetrit S. Low extracellular Ca2+: a mediator of endothelial inflammation. Nephrol Dial Transplant. 2009 Nov;24(11):3306-12. doi: 10.1093/ndt/gfp354. Epub 2009 Jul 18.
citation: Rashid G, Plotkin E, Klein O, Green J, Bernheim J, Benchetrit S. Parathyroid hormone decreases endothelial osteoprotegerin secretion: role of protein kinase A and C. Am J Physiol Renal Physiol. 2009 Jan;296(1):F60-6. doi: 10.1152/ajprenal.00622.2007. Epub 2008 Oct 22.