louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01734278: Observational Post-Authorisation Safety Study of Asenapine (Sycrest)
Official title: An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Manic Disorder
Lead sponsor: Drug Safety Research Unit, Southampton, UK
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-11-27
Enrollment: 1000
Sex: ALL
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: Patients prescribed asenapine in a NHS Mental Health Trust in England.

Brief summary: The purpose of this observational study is to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the manufacturer of Sycrest.


Eligibility criteria: Inclusion Criteria:

* Patients for whom a study questionnaire containing useful information has been returned

Exclusion Criteria:

* Patients who do not provide consent
* Patients within selected institutions (for example prisons)
* Patients who commenced treatment between date of market launch (to be confirmed) and study start
* Enrolled patients for whom both the baseline and 12-week questionnaires are returned blank (contain no clinical information)
* Enrolled patients for whom the psychiatrist, designated member of clinical care team, or study facilitator from the DSRU reports that the patient did not take or was never prescribed asenapine
* Enrolled patients for whom there is evidence to suggest duplication of patients
* Enrolled patients for whom informed written or verbal notification is received by DSRU indicating that they no longer wish to participate at any stage of the study

Primary outcomes:
measure: The incidence of selected identified risks of asenapine in the mental health care trust setting
timeFrame: 12 weeks after asenapine is first prescribed
Secondary outcomes:
Other outcomes:
Locations:
city: Stafford
country: United Kingdom
facility: South Staffordshire and Shropshire Healthcare NHS Foundation Trust
state: Staffordshire
Study officials:
References:
Clinical trial NCT00315978: The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention
Official title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Risk Assessment
Decision Support Technique
Physician-Patient Relations
Prevention and Control
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.

Detailed description: Background: Low utilization of effective CHD prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention.

Methods: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor.

Eligibility criteria: Inclusion Criteria:

* presenting for routine medical care with regular medical provider
* able to understand, speak, and read English

Exclusion Criteria:

* prior history of cardiovascular disease
* history of serious medical illness that would limit candidacy for screening
* previous participation in intensive risk modification as part of diabetes study in our clinic
* no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate

Primary outcomes:
measure: Discussion with provider about CHD risk reduction
measure: Stated plans for CHD risk reduction
Secondary outcomes:
measure: Knowledge about CHD prevention
measure: Perception of CHD risk
measure: Interest in participating in decision-making
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacey L. Sheridan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheridan SL, Shadle J, Simpson RJ Jr, Pignone MP. The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial. BMC Health Serv Res. 2006 Sep 27;6:121. doi: 10.1186/1472-6963-6-121.
Clinical trial NCT02714478: "Equistasi" and Gait in Hemiparesis
Official title: Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemiparesis
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.


Eligibility criteria: Inclusion Criteria:

* subacute hemiparesis
* Functional Ambulation Classification \<4

Exclusion Criteria:

* previous neurological deficits
* Glasgow Coma Scale \<13
* Complete sensory deficit in the lower limbs
* Levels of Cognitive Functioning ≤5
* polyneuropathy
* contraindications to mobilization/verticalization

Primary outcomes:
measure: disability change assessed using Functional Independence Measure scale
timeFrame: 0. 30. 60. 120 days
measure: balance change assessed using Berg Balance Scale
timeFrame: 0. 30. 60. 120 days
measure: gait pattern change assessed using Functional Ambulation Classification scale
timeFrame: 0. 30. 60. 120 days
measure: gait speed change assessed using Timed Up and Go scale
timeFrame: 0. 30. 60. 120 days
measure: gait pattern change using Tinetti scale for gait
timeFrame: 0. 30. 60. 120 days
measure: gait speed change assessed using 10 meter walking test scale
timeFrame: 0. 30. 60. 120 days
measure: swaying of the center of gravity change assessed with stabilometric platform indexes
timeFrame: 0. 30. 60. 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
state: CO
Study officials:
References:
Clinical trial NCT03842878: Natural History Study of Patients With Limb-Girdle Muscular Dystrophy 2I
Official title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Limb-Girdle Muscular Dystrophy 2I
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: LGMD2I
Lead sponsor: Genethon
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients ≥ 16 years old

Brief summary: Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

Detailed description: Study duration Duration from First visit of first patient (FPFV) to Last visit of last patient (LPLV) : 3 years

Study objectives Primary objective:

To characterize the disease course in Limb-Girdle Muscular Dystrophy 2I (LGMD2I) patients using standardized and disease appropriate evaluations.

Secondary objectives:

To identify clinical, imaging and/or laboratory parameters that are indicators of the disease course in LGMD2I To identify the best outcome measure for further therapeutics approaches

Eligibility criteria: Inclusion Criteria:

1. Female and male patients
2. Patients ≥ 16 years old
3. Clinical diagnosis of LGMD2I and gene testing demonstrating two pathogenic mutations in fukutin-related protein gene, FKRP)
4. Ambulant patients

Exclusion Criteria:

1. Patients presenting other disease which may significantly interfere with the interpretation of LGMD2I natural history

Primary outcomes:
measure: 6-Minute Walk Test
timeFrame: Baseline through 24 months
measure: 10-Meter Walk test (10MWT)
timeFrame: Baseline through 24 months
measure: Timed Up and Go (TUG) test
timeFrame: Baseline through 24 months
measure: Four-stair climb test
timeFrame: Baseline through 24 months
measure: North Star Assessment for Neuromuscular Disorders (NSAD)
timeFrame: Baseline through 24 months
measure: Upper limb assessment via the Performance of the Upper Limb (PUL) tool version 2.0
timeFrame: Baseline through 24 months
measure: Recording of aids for ambulation
timeFrame: Baseline through 24 months
measure: Isokinetic muscle testing using the Biodex System (optional)
timeFrame: Baseline through 24 months
measure: Pulmonary function test
timeFrame: Baseline through 24 months
measure: Electrocardiogram
timeFrame: Baseline through 24 months
measure: Echocardiography
timeFrame: Baseline through 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Pr John Vissing
city: Paris
country: France
facility: Dr Tanya Stojkovic
city: Newcastle
country: United Kingdom
facility: Pr Volker Straub
Study officials:
affiliation: Professor of neurology
name: John Vissing, PR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280578: The Coherex FlatStent™ EF PFO Migraine Registry
Official title: The Coherex PFO Migraine Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients With Migraine and PFO
Keywords: Migraine
Lead sponsor: Coherex Medical
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NA. Study terminated

Brief summary: A prospective, single arm, multicenter clinical registry evaluating the change in migraine headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with the Coherex FlatStent™ EF PFO Closure System.


Eligibility criteria: Major Inclusion Criteria:

Age 18-65 males and non pregnant females History of refractory migraine Documented PFO

Major Exclusion Criteria:

Known allergy to aspirin or nickel. Medication Overuse Headache Body mass index \> 40. Recent Botulinum neurotoxin type A treatment Other known structural heart disease, coronary artery disease, atrial fibrillation PFO morphology not suitable for FlatStent EF Patients who have had a stroke within the past two months Post-traumatic headache. Patients with diagnosed hypercoagulable states that require chronic treatment with warfarin.

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Closure efficacy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01381978: Obesity Childhood in Cuenca-Ecuador: Prevalence and Risk Factors
Official title: Baseline Study. Obesity Childhood in Cuenca-Ecuador: Prevalence and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Nutritional status of scholars
Risk factors of obesity
Socioeconomical status
Physical activity habits
Lead sponsor: Universidad de Cuenca
Sponsor class: OTHER
Collaborators: name: University Rovira i Virgili
name: Universiteit Antwerpen
First posted: 2011-06-27
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children (girls and boys) 6 to 9 years of age. Sample ramdomized of urban schools of Cuenca Ecuador

Brief summary: Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and physical activity habits.

Summary:

The prevalence of obesity and overweigh in all age groups are increasing rapidly in the world. Some factors like physical activity, socioeconomical status, dietary habits, gender, besides genetic factors influence in the development of obesity.

In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in children and the risk factors related.

Socioeconomical status and quality of physical activity are assessed using specially designed questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca city. Nutritional status is assessed using body mass index, relation weight/age and height/age. These data are helpful to develop programs focused to improve nutritional status in scholars of Cuenca.


Eligibility criteria: Inclusion Criteria:

* All children of selected sample with an approved consent by their parents

Exclusion Criteria:

* Children with malformations that not permit take anthropometric measures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: Universidad de Cuenca
state: Azuay
Study officials:
References:
Clinical trial NCT00917878: Postprandial Effects of Milk and Milk Constituents
Official title: The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Inflammation
Keywords: Milk
Postprandial hyperlipidemia
Postprandial inflammation
Overweight
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nederlandse Zuivel Organisatie
First posted: 2009-06-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) above 27 kg/m2

Exclusion Criteria:

* Smoking
* Diabetes mellitus
* Cardiovascular diseases
* Familial hypercholesterolemia or lipid lowering medication
* Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
* Unstable body weight
* Abuse of alcohol or drugs
* Participation in another biomedical study during the past 30 days
* Having donated blood during the past 30 days

Primary outcomes:
measure: Plasma inflammatory markers
timeFrame: 6 h after meal
Secondary outcomes:
measure: Serum lipids
timeFrame: 6 h after meal
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald P Mensink, Prof. Dr. Ir.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04085978: Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission
Official title: A Retrospective Analysis of the Effects of a Hypoglycemia Protocol With Glucose Gel on NICU Admission
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypoglycemia
Neonatal Hypoglycemia
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Banner University Medical Center
First posted: 2019-09-11
Enrollment: 400
Sex: ALL
Minimum age (years): 34
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To detect a 130% increase in NICU length of stay with power of 0.8, the investigators calculated a sample size of 400 subjects with 200 subjects before and after implementation. It is estimated that the data collection period is roughly over the course of one year, with the assumption that not all neonates with hypoglycemia will meet the inclusion criteria.

Brief summary: Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.

Detailed description: This project will evaluate various aspects of infants with hypoglycemia admitted to the Neonatal Intensive Care Unit (NICU) pre- and post- implementation of a hospital-wide hypoglycemia protocol with oral glucose gel. Subjects will be matched by gestational age (GA), birth weight rounded to the nearest half kilogram, ethnicity, gender, maternal age, maternal diabetes status, maternal parity, maternal ethnicity, and mode of delivery. Retrospective data will be reviewed including neonatal and maternal demographics and NICU medical course data. The results of this study can inform intended and unintended consequences of the instituted protocol.

Eligibility criteria: Inclusion Criteria:

* All neonates born at Banner University Hospital during January 01, 2014 - November 30, 2016 and January 01, 2018 - November 30 2018 who qualify for hypoglycemia protocol.

Exclusion Criteria:

* Neonates \<34 weeks gestational age or with birth weight less than 2000 grams.
* Infants with serious congenital malformation
* Infants with a terminal disorder.

Primary outcomes:
measure: Mean NICU length of stay rounded to the day
timeFrame: 30 days
measure: Mean maximum glucose infusion rate
timeFrame: 30 days
Secondary outcomes:
measure: Assess for complications
timeFrame: 30 days
measure: Assess for weight loss
timeFrame: 30 days
measure: Evaluate for persistent symptomatic or asymptomatic hypoglycemia
timeFrame: 30 days
measure: Number of neonates who received formula
timeFrame: 30 days
measure: Number of neonates with any breastfeeding during hospitalization
timeFrame: 30 days
measure: Number of neonates with breastfeeding at time of discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Pediatrix
name: Gregory Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06870578: Building Research for Intervention Development in Gliosis and Eating Habits
Official title: Fostering Patient-oriented Research in Cardiometabolic Disease Pathogenesis and Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gliosis
Child Obesity
Eating
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-03-11
Enrollment: 75
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.


Eligibility criteria: Inclusion Criteria:

* Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
* Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
* Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.

Exclusion Criteria (study 1 child participants and study 3 criteria for children of adult participants):

* Significant health conditions including type 2 diabetes
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* Severe food allergies, vegetarian, or vegan (Study 1 only)
* Unable to make the session date

Exclusion Criteria (study 2, child participants):

* Significant health conditions including type 2 diabetes
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* MRI contraindication (e.g., braces, claustrophobia)
* Weight \>330 pounds (MRI limit)
* Severe food allergies, vegetarian, or vegan
* Currently in formal weight loss program

Primary outcomes:
measure: T2 relaxation time by brain MRI
timeFrame: 7 days of diet intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ellen Schur, MD
role: PRINCIPAL_INVESTIGATOR
References: