louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04579939: Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
Official title: Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to determine if a popular dextrose candy alternative yields a similar glycemic curve compared to the standard oral Dextrose solution used in the Oral Glucose Tolerance Test.


Eligibility criteria: Inclusion Criteria:

* Males and Females ages 10-21 years.
* Cystic Fibrosis (CF) must be diagnosed.
* Ability to sign informed consent if they are 18 years or older.
* Written parental permission if age 10-17 years old.

Exclusion criteria:

* Active CF flare as determined by the primary CF team .
* Use of steroids.
* Inability to tolerate oral feedings.
* Prior intestinal surgery.
* Concern for allergy or intolerance to dextrose, fructose, or corn derivatives.

Primary outcomes:
measure: Glycemic Response
timeFrame: Baseline, Day 1
Secondary outcomes:
measure: Patient and Parent Satisfaction
timeFrame: Day 2
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ana Creo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05917639: CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial
Official title: CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Literacy
Confidence, Self
Keywords: shared decision-making
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 2178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: How health-related information is communicated affects what is understood and might influence how people make decisions and how confident they feel in participating in clinical shared decision-making.

The CICERO trial will compare three different communication tools providing information on fictional interventions for a common medical problem (i.e. social anxiety disorder) both in terms of how well interventions work (benefit) and also possible harms associated (risk). The three communication tools ("Summary of Findings table", "Kilim plot", and "Vitruvian plot") differ in how they present information: exclusively written, primarily written and partially graphical, or mixed written and visual. Each participant will be asked to go through one clinical scenario.

The investigators will ask participants to familiarise themselves with the tool they have been allocated to (either a plot or a table) and then answer some validated questionnaires to measure how useful and efficient the communication strategy was.

The entire study occurs online in a single study session (about 20 minutes).

The results of the CICERO trial will inform how to communicate research findings to the general population, facilitating their implementation in clinical shared decision-making.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65 years (inclusive)

Primary outcomes:
measure: Decisional Conflict Scale, low literacy version
timeFrame: through study completion, an average of 20 minutes
Secondary outcomes:
measure: Decision Self-Efficacy scale
timeFrame: through study completion, an average of 20 minutes
measure: Preparation for Decision Making scale
timeFrame: through study completion, an average of 20 minutes
measure: Information comprehension (proportion of participants providing a correct answer)
timeFrame: through study completion, an average of 20 minutes
Other outcomes:
measure: Number of minutes to complete the questionnaire
timeFrame: through study completion, an average of 20 minutes
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Precision Psychiatry Lab (OxPPL)
Study officials:
References:
Clinical trial NCT00026039: Women's Estrogen for Stroke Trial (WEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
estrogen
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
First posted: 2001-11-08
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED

Brief summary: To determine if estrogen hormone replacement therapy reduces the risk of stroke or death in postmenopausal women who have already had stroke or a transient ischemic attack (TIA).

Detailed description: The researchers enrolled 664 postmenopausal women with an average age of 71 years who had experienced an ischemic stroke or a TIA within the previous 90 days. Ischemic strokes and TIAs result from blockages in the vessels that supply blood to the brain. Participants were given a number of initial assessments, including the NIH Stroke Scale (NIHSS) of neurological impairment and the Barthel index of functional ability in activities of daily living. In addition to the usual best care for patients who have had a stroke, women in the trial received either oral estrogen (estradiol 17-beta at the standard replacement dose of 1 mg daily) or a matching placebo. Patients were studied for an average of 2.8 years. They stopped receiving the estrogen or placebo if they had a stroke.

The researchers found that there was no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo. However, they found that the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at 1 month after stroke. The risk of stroke within the first 6 months after enrollment in the study was also higher among women in the estrogen group. There were no significant differences between treatment groups in the number of TIAs or non-fatal heart attacks. However, participants receiving estrogen were more likely to experience gynecologic complications, particularly vaginal bleeding.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Ralph I. Horwitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833339: Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
Official title: Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2009-02-02
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.


Eligibility criteria: Inclusion Criteria:

* Subject is a male U.S. veteran
* Subject was exposed to combat or another criterion A traumatic event during military service
* Subject meets diagnostic criteria for chronic PTSD

Exclusion Criteria:

* Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
* Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
* Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
* Veteran is taking oral corticosteroids
* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
* Veteran is currently suicidal or otherwise is in need of urgent clinical care
* Veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing).
* Veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication
* Veteran has history of allergic reaction to mifepristone

Primary outcomes:
measure: Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
timeFrame: baseline, endpoint, 4 week follow-up
Secondary outcomes:
measure: Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.
timeFrame: baseline, endpoint, 4 week follow-up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: JJP VAMC; Mount Sinai Sch of Med
name: Julia A Golier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025539: Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder
Official title: Effects of an Animal-assisted Resilience Training for Children With a History of Stressful Life Events or a Diagnosis of Autism Spectrum Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Life Change Events
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about the effects of an animal-assisted resilience training in children who experienced stressful life events or who have a diagnosis of autism spectrum disorder. The main question it aims to answer is:

• Is an animal-assisted resilience training a feasible approach to increase resilience in children with a history of stressful life events or a diagnosis of autism spectrum disorder?

Participants will take part in 12 training sessions of a standardized resilience training. The training is group-based, takes place outdoors, and includes interactions with different animals. It focuses on self-esteem, self-perception, dealing with emotions, and social competence.


Eligibility criteria: Inclusion Criteria:

* Age between 2 and 4 years (toddler group) or 8 and 12 years (children group)
* History of at least one stressful life event experience OR diagnosis of autism spectrum disorder
* Basic knowledge of either German or English of parents and child to follow the instructions during the training sessions and completion of interviews.

Exclusion Criteria:

- Medical contraindications for contact with animals, such as allergies or phobia

Primary outcomes:
measure: Questionnaire on resources in childhood and adolescence
timeFrame: 18 weeks
Secondary outcomes:
measure: Questionnaire to assess emotion regulation in children and adolescents
timeFrame: 18 weeks
measure: Number of attended sessions
timeFrame: 12 weeks
measure: Feeling secure and motivation to participate as measured on a 0-10 scale
timeFrame: 12 weeks
measure: Intervention satisfaction as assessed in semi-structured interview
timeFrame: 18 weeks (follow-up)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
References:
Clinical trial NCT03153839: Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies
Official title: Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Behavior
Gestational Age Over 30 Weeks
Keywords: Children
Babies
Infant
Swimming pool
Aquatic physical activity
Motor development
Neurodevelopment
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 145
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs.

Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year.

Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.


Eligibility criteria: Inclusion Criteria:

* Commitment to participate voluntarily.
* Signing informed consent to participate in the research, according to the Helsinki Declaration, updated at the 64th General Assembly, Fortaleza, Brazil, October 2013.

Exclusion Criteria:

* Babies who are born with a gestational age of less than 30 weeks.
* Baby changes that prevent physical activity.

Primary outcomes:
measure: Evaluation of baby development
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the development of affectivity
timeFrame: 12 months
measure: Gestational age
timeFrame: 37- 42 Weeks
measure: Labour alterations
timeFrame: 3 months
measure: Apgar at birth
timeFrame: 3 months
measure: Newborn data
timeFrame: 3 months
measure: Type of childbirth
timeFrame: 3 months
measure: Nutrition of the baby.
timeFrame: 12 months
measure: Family demographic variables
timeFrame: 3 months
measure: Family history of illness.
timeFrame: 3 months
measure: Toxic habits of parents
timeFrame: 3 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granda
Study officials:
References:
Clinical trial NCT00594139: Autologous Neo-Bladder Construct in Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence
Official title: An Open Label Multi-center Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: non-neurogenic over active bladder
urge predominant incontinence
Lead sponsor: Tengion
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 0
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: Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Detailed description: Subjects with non-neurogenic over-active bladder and urge predominant incontinence who are intolerant to medical therapy or have persistence of symptoms despite medical therapy and require augmentation cystoplasty will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Eligibility criteria: Inclusion Criteria:

* History of non-neurogenic overactive bladder for at least 12 months prior to study entry
* Intolerance to medical therapy or persistence of symptoms despite medical therapy

Exclusion Criteria:

* Subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence
* Use of Botulinum Toxin A injections into the bladder within the previous 6 months
* Presence of a neuromodulator
* Using catheterization as a way to control incontinence
* History of bladder cancer

Primary outcomes:
measure: Mean number of micturitions per day
timeFrame: 12 months
measure: Overall safety
timeFrame: 12 months
Secondary outcomes:
measure: Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince
timeFrame: periodically within first 12 months as well as during long term follow up out to 5 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Tengion, Inc
name: Michael Tillinger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00846339: PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration
Official title: [11C] Raclopride PET Imaging Study That Investigates Relation Between Occupancy of Dopamine D2 Receptors and Genotypes of DRD2 After Bupropion Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Keywords: Smoking cessation
Bupropion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Welfare and Family Affairs
name: Korea National Enterprise for Clinical Trials
First posted: 2009-02-18
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bupropion has different effects on D2 dopamine receptors according to genotype.

Detailed description: Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline raclopride PET (High Specific Activity, Low Specific Activity).

* Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication, pharmacokinetic and PET studies are performed.
* Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of medication, pharmacokinetic and PET studies are performed.

Eligibility criteria: Inclusion Criteria:

* Active smoker (more than 10 cigarettes per day for the past 2 years)

Exclusion Criteria:

* Medical or psychiatric co-morbidity
* Hypersensitive to bupropion

Primary outcomes:
measure: Dopamine receptor occupancy
timeFrame: 1 week
Secondary outcomes:
measure: Pharmacokinetic parameters of bupropion and hydroxybupropion
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National Univeristy Hospital
name: Kyung-Sang Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02330939: Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes
Official title: Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Postprandial glycemia
Momounsaturated fatty acids
Saturated fatty acids
Glycemic index
Glycemic load
Sensor augmented pump system
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. This interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.


Eligibility criteria: Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

* Pregnancy
* Celiac disease

Primary outcomes:
measure: postprandial incremental glucose AUC
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical Medicine and Surgery
Study officials:
References:
citation: Bozzetto L, Alderisio A, Clemente G, Giorgini M, Barone F, Griffo E, Costabile G, Vetrani C, Cipriano P, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Gastrointestinal effects of extra-virgin olive oil associated with lower postprandial glycemia in type 1 diabetes. Clin Nutr. 2019 Dec;38(6):2645-2651. doi: 10.1016/j.clnu.2018.11.015. Epub 2018 Dec 4.
citation: Bozzetto L, Alderisio A, Giorgini M, Barone F, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Extra-Virgin Olive Oil Reduces Glycemic Response to a High-Glycemic Index Meal in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2016 Apr;39(4):518-24. doi: 10.2337/dc15-2189. Epub 2016 Feb 9.