louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02032940: Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique
Official title: Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Focus of Study is MRI
Keywords: MRI, Angiography, Pulse Sequence
Lead sponsor: Miami Cardiac and Vascular Institute
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients Needing Thoracic, Aortic, Renal, Iliac and/or Femoral Vasculature MRIs

Brief summary: The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents.

Detailed description: The t-SLIP Investigational Study Sequences are designed to compare t-SLIP to standard MR contrast enhanced imaging techniques to establish the diagnosic benefits of t-SLIP compared to contrast enhanced MR techniques. The t-SLIP Investigational Study Sequences will be used for vascular MRI Imaging including, but no limited to, MRA of the renal, mesenteric, abdominal aortic, iliac and femoral arteries. We will be targeting all adult patients undergoing standard body MRA examinations without anesthesia.

The time spatial labeling inversion pulse (t-SLIP) technique is used for non contrast enhanced MR angiography imaging. It produces bright blood spin labeling images by using a single acquisition with a combination of a spatially nonselective inversion pulse and a spatially selective inversion pulse. The nonselective pulse inverts the magnetization of the entire imaging area. The spatially selective pulse, applied upstream of the arteries of interest, reverts those protons to full magnetization. A pre defined time delay between tagging and imaging allows the tagged spins to reach the imaging region and suppresses background tissue within the imaging region to some extent.

Eligibility criteria: Inclusion Criteria:

* All patients that are considered candidates and scheduled for standard contrast enhanced MRA can be included in the study.

Exclusion Criteria:

* Patients that can not undergo standard MRA

Primary outcomes:
measure: Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute
state: Florida
Study officials:
affiliation: Baptist Cardiac and Vascular Institute
name: Constantino Pena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005567: Parental Knowledge and Beliefs About Infant Sleep Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Infant Death Syndrome
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-04-24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Primary purpose: ECT

Brief summary: In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the usual sleep position has changed from the stomach to the side or back. Back sleep has been shown to be the most stable and safest position. The American Academy of Pediatrics now recommends the back sleeping position for all healthy infants. Since the American Academy of Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by more than 40% in this country. However, the decrease has not been uniform across segments of the population. Black infants continue to have a higher rate of SIDS compared with other groups. This discrepancy could be related to infant sleep position practices. Several studies have shown that infants born to low income, minority, inner-city families were more likely to be placed on the stomach to sleep. Education appears to influence choice of sleep position and may explain, at least to some degree, the difference in choice of sleep position among certain groups. We believe that uniform education of parents will influence the sleep position that parents choose for their baby. We will undertake this initial study to document what parents choose to do with their infants regarding sleep position and why they make these choices so that we can improve our educational approach.


Eligibility criteria: Inclusion Criteria:

* Parent of a two-week old infant born in the Well Newborn Nursery at Yale-New Haven Hospital. Infant is brought for well child care at Yale-New Haven Hospital Primary Care Center

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01932840: Attitudes and Understanding of Plant Sterol Claims on Food Labels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Population
Consumer Research
Keywords: attitudes and understanding of plant sterol claims
general Canadian population
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Advance Foods and Materials Network
First posted: 2013-08-30
Enrollment: 1017
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subsection of the Canadian Consumer Monitor Panel - a national representative online consumer panel comprised of 30,000 Canadians

Brief summary: Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.

The objective of this study was to evaluate the attitudes and understanding of different types of plant sterol claims on food labels


Eligibility criteria: Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an active email address or access to internet

Primary outcomes:
measure: Response to survey questions measuring attitudes towards plant sterol claims using 5-point likert rating scales
timeFrame: On average the survey took 25 min to complete
measure: Response to survey questions evaluating participants understanding of plant sterol claims
timeFrame: On average the survey took 25 minutes to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Toronto
name: Mary R L'Abbé, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04565340: Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes
Official title: Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Rupture of Membranes at Term
Mode of Delivery
Keywords: Complications and outcomes maternal and neonatal
Induction of labor
Prostaglandins
Foley Catheter
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Premature Rupture Of Membranes at term (\>37SA) at Montpellier University Hospital

Brief summary: Premature rupture of membranes at term is a rupture that occurs at term (\>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.

Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.

The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.


Eligibility criteria: Inclusion criteria:

* Singleton Pregnancy \>37 weeks of gestation
* Premature Rupture Of Membranes
* Cephalic presentation
* Unfavorable cervix (BISHOP \<7)
* No contraindication of induction methods

Exclusion criteria:

* Multiple gestation
* PROM with spontaneous labor
* Induction of labor with both methods
* Previous cesarean section
* Unexplained metrorrhagia / Placenta praaevia
* Suspected intraamniotic infection
* Herpes simplex virus
* Human immunodeficiency virus
* Any contraindication to vaginal delivery
* Latex allergy

Primary outcomes:
measure: mode of delivery (vaginal delivery or cesarean)
timeFrame: 1 day
Secondary outcomes:
measure: maternal and fetal outcomes
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02528240: Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
Official title: Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Keywords: platelets
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.


Eligibility criteria: Inclusion Criteria:

* Provision of Informed Consent
* Patients in need of an EMS
* EMS is the only option to cure the periapical lesion

Exclusion Criteria:

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Orthograde endodontic (re)treatment is indicated
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* History of bleeding disorders
* HIV disease

Primary outcomes:
measure: Patient related outcomes
timeFrame: 7 days
Secondary outcomes:
measure: Patient related outcomes
timeFrame: 7 days
Other outcomes:
measure: Amount of periapical bone healing in time
timeFrame: 4 years
measure: Timeframe in which the cortical bone plate closes
timeFrame: 1 year
measure: Bone or scar tissue healing
timeFrame: 4 years
measure: Dentinal defects
timeFrame: 1 day
measure: Type of periapical tissue
timeFrame: 7 days
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT05308940: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects
Official title: A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shenzhen Turier Biotech Co., Ltd
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Written and signed informed consent.
2. Aged 18-55 years (inclusive), male or female.
3. BMI within 18.0-28.0 kg/m2 (inclusive).
4. Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
5. Have agreed to take effective contraception measures.

Exclusion Criteria:

1. Have any prior clinically serious disease of any system.
2. Known or suspected allergy to the study drug or any of its ingredients.
3. Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
4. History of recurrent or chronic infection within 6 months prior to the first administration.
5. Unable to comply with dietary management during the study period.
6. Pregnant or lactating women.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Day 1 and up to Day 28
Secondary outcomes:
measure: Pharmacokinetics exposure of TB001 in SAD and MAD stage
timeFrame: Day 1 , Day 7
measure: Observed immunogenicity of TB001 in MAD stage
timeFrame: Day 1, Day 7, Day 14, Day 28
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Turier Biotech Co., Ltd.
state: Guangdong
Study officials:
References:
Clinical trial NCT00285740: Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Depressive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Epilepsy Foundation
First posted: 2006-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic population. There are 12 sessions of therapy in the study held once a week for 12 weeks.

Detailed description: Depression is frequent in PWE and often missed for unclear reasons. Busy neurology clinics and their overworked physicians often lack psychiatric backup that may make inquiring about psychological issues problematic. In the psychiatric community, awareness of the need for depression intervention in the primary care clinic has been recognized for many years and several treatment models exist. This study will attempt to use one such model, i.e. Cognitive-Behavioral Therapy (CBT) using a group format and tailoring its use for an epilepsy clinic population.

Eligibility criteria: Inclusion Criteria::- Patients will be screened with the Beck Depression Inventory. Those reaching the positive cut-off score of 11 (indicating at least a mild depression) will be entered into the study. Patients entered on antidepressants will be held at a stable dosage. Anti-epileptic drugs will also be maintained on the same dosage at entry into the study when possible clinically, after consultation with their neurologist. Exclusion Criteria:- Patients will be excluded if there is any active serious medical conditions, Standard Score\<70 as assessed via the Wide Range Achievement Test, psychotic or substance abuse issues, those who are unable to maintain a stable dose of medications for the duration of study.

Primary outcomes:
measure: Beck Depression Inventory
Secondary outcomes:
measure: NDDI
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: John J Barry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423040: Social Media Chatbot on Physical Activity Education for Older Adults
Official title: Exploring the Effectiveness of Applying Social Media Chatbot for Providing Real-Time Feedback on Physical Activity Education for Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise
Self Efficacy
Behavioral Regulation
Healthy Aging
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, a social media chatbot was used to provide a continuous and real-time multimedia health education program on physical activity for the older adults, as well as supportive messages and feedbacks, to improve physical activity and exercise self-efficacy among the older adults. This study was a cluster randomized trial, and participants were recruited from community care stations and activity centers in Taipei City. The experimental group was involved in an 8-week, 5-day-a-week intervention with a total of 40 multimedia physical activity education programs, and users were provided with real-time feedback interactions and regular physical activity education guidelines, and self-administered questionnaires were used for data collection. The research instruments include basic personal information, International Physical Activity Questionnaire, Exercise Self-Efficacy Scale, Behavioral regulation in exercise questionnaire-2, Exercise Benefits/Barriers Scale, and the statistical methods will be descriptive statistics, independent sample t-test, paired sample t-test, and one-way analysis of covariance.


Eligibility criteria: Inclusion Criteria:

1. Persons aged 60 to 85 years old living in Taipei City, healthy or with chronic conditions
2. Those who can listen, read and write Chinese
3. Those who have used smartphones in the past month and can use Line social software
4. Those who voluntarily participate in this study, can understand the research content after explanation and explanation, and sign the subject consent form

Exclusion Criteria:

1. Those who are advised by a doctor not to exercise
2. Those who must exercise under the supervision of medical personnel
3. Patients with severe cardiovascular disease
4. Anyone with disability or cognitive impairment
5. Persons living in long-term care institutions

Primary outcomes:
measure: Physical activity
timeFrame: up to 8 weeks
measure: Self-Efficacy
timeFrame: up to 8 weeks
measure: Behavioral regulation
timeFrame: up to 8 weeks
measure: Benefits/Barriers
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University
Study officials:
References:
Clinical trial NCT01264640: Anti-Platelet Drugs and Brain-derived Neurotrophic Factor (BDNF) in Human Serum and Plasma
Official title: The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Brain-derived neurotrophic factor (BDNF)
Platelets
Aspirin
Clopidogrel
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Gender: Male

Exclusion Criteria:

* Any acute disease
* Any chronic disease
* Any medication
* Allergies / Intolerance in association with Aspirin or Clopidogrel

Primary outcomes:
measure: BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake
timeFrame: 24 hours
Secondary outcomes:
measure: 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Dep. of Pneumology, University of Rostock
state: Mecklenburg-Vorpommern
Study officials:
affiliation: University of Rostock
name: Marek Lommatzsch, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lommatzsch M, Zingler D, Schuhbaeck K, Schloetcke K, Zingler C, Schuff-Werner P, Virchow JC. The impact of age, weight and gender on BDNF levels in human platelets and plasma. Neurobiol Aging. 2005 Jan;26(1):115-23. doi: 10.1016/j.neurobiolaging.2004.03.002.