louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04629586: The T1D Exchange Registry
Official title: The T1D Exchange Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Diabetes
Type 1 Diabetes
Diabetes Mellitus
Keywords: insulin
t1d
dm
diabetes
type 1
glucagon
Lead sponsor: T1D Exchange, United States
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 50000
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: Individual diagnosed with type 1 diabetes who can access online Registry.

Brief summary: The T1D Exchange Registry is a research study, conducted over time, for individuals with type 1 diabetes and their supporters. Participants volunteer to provide their data for research (for example, by answering questions in annual surveys). Once enrolled, Registry participants have the opportunity to sign up for other studies on various topics related to type 1 diabetes.

To participate, you will be asked to:

* Read and sign an online informed consent form
* Take a survey describing specific demographic and type 1 diabetes management information
* Update your information annually
* Periodically opt in for additional research opportunities (if you choose), i.e. taking new surveys or uploading health device data


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes.
* Individuals younger than 18 years of age must have parent/guardian consent.
* Must be able to read and understand English.
* Currently living in the United States

Exclusion criteria:

* Does not use insulin and has not had a pancreatic or islet cell transplant.
* Cannot fully read and understand English.
* Does not currently live in the United States.

Primary outcomes:
measure: Gather longitudinal data from individuals living with type 1 diabetes.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: T1D Exchange
state: Massachusetts
Study officials:
References:
Clinical trial NCT06680986: Echocardiographic Analysis by Artificial Intelligence in Hypertension
Official title: Echocardiographic Analysis by Artificial Intelligence in Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Hypertension
Keywords: Hypertension
HTN
Arterial Hypertension
Artificial Intelligence
AI
Cardiac remodelling
Left ventricular hypertrophy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 200
Sex: ALL
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: Patients who underwent a comprehensive hypertension assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021

Brief summary: The objective of this study is to develop artificial intelligence (AI) tools to characterize cardiac remodelling in arterial hypertension through the analysis of routine imaging data (echocardiography) coupled with patient data. More precisely, this study will make it possible (i) to represent in a relevant way the spectrum of the cardiac repercussions of a population affected by hypertension to better characterize the progress of the pathology, in particular vis-à-vis the more ambiguous subjects to be characterized ("grey" area); (ii) to develop tools for the automatic quantification of cardiac function (segmentation and robust monitoring of the myocardium during the cardiac cycle, for the dynamic analysis of the shape and global deformation of the heart) and therefore to extract descriptors richer in cardiac function than those currently used in clinical routine.


Eligibility criteria: Inclusion Criteria Patients who underwent a comprehensive blood pressure assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021.

Exclusion Criteria Patients who are minors. Patients under curatorship or guardianship.

Primary outcomes:
measure: Arterial Blood Pressure
timeFrame: Baseline
measure: Number of Antihypertensive Medications
timeFrame: Baseline
measure: NT-proBNP Concentration
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud
Study officials:
References:
Clinical trial NCT05012839: Complicated Appendicitis in COVID-19 Era
Official title: Increased Incidence of Adult Complicated Appendicitis in One Resource-Competent Community During the Coronavirus Disease Pandemic: Time to Improve Health-Seeking Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Complicated Appendicitis
Keywords: Health-seeking behavior
COVID-19
appendicitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 465
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.

Brief summary: Background The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic.

Methods A retrospective analysis of acute appendicitis in adults was performed between January 1 and June 30, 2020 (COVID-19 period). The control period was collected from the first two quarters for the preceding 3 years. Outcome measures were ACA and length of hospital stays.


Eligibility criteria: Inclusion Criteria:

* Acute appendicitis

Exclusion Criteria:

* No

Primary outcomes:
measure: Incidence of complicated appendicitis
timeFrame: baseline, pre-surgery
Secondary outcomes:
measure: Length of hospital stays
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06569186: Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
Official title: Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infant, Very Low Birth Weight
Infant Development
Feeding Patterns
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 74
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and Control groups
Primary purpose: TREATMENT

Brief summary: In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.


Eligibility criteria: Inclusion criteria:

* Birthweight \< 1500 grams
* Gestational age between 28 and 31 weeks of gestation
* Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
* Oral feeding initiated before 33 weeks PMA.

Exclusion criteria:

* Major congenital/chromosomal anomalies,
* Patent ductus arteriosus causing significant cardiovascular symptoms
* History of necrotizing enterocolitis stage 2 or greater

Primary outcomes:
measure: Time interval in days from introduction to attainment of independent oral feeding
timeFrame: 4-20 days
Secondary outcomes:
measure: Postnatal age at discharge in days
timeFrame: 34 to 40 weeks postnatal age
measure: Length of hospital stay in days
timeFrame: 10-60 days
measure: Average weight gain during the transition from tube to oral feeding
timeFrame: 10-60 days
measure: Total number of tube feeding events per infant during the transition from tube to oral feeding
timeFrame: 10-60 days
measure: Follow up phone call
timeFrame: 4-6 months after birth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT01179386: Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping
Official title: Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: methylphenidate
ADHD
driving
simulator
pressure
adolescent
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 adolescents aged 15-18 years ,diagnosed as suffering from ADHD and being treated with a methylphenidate medication that is used in Israel 30 adolescents aged 15-18, without ADHD will the control group

Brief summary: Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication.

Detailed description: Adolescents with ADHD who are treated with one of the methylphenidate medication that is in use in Israel(Ritalin,Ritalin SR,Concerta,Ritalin LA)will be tested by driving simulator and seat pressure mapping by 2 stages: 1.when they are taking the medication that they are taking every day to control ADHD and: 2. without medication ( after 4 day washout period).

Eligibility criteria: Inclusion Criteria:

* age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license

Exclusion Criteria:

* any other neurological or psychiatric problem under treatment or investment adolescents who have driving license

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Cohen Herman Avner
Study officials:
affiliation: sherute briut clalit
name: cohen he avner, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: razon nava, Dr
role: STUDY_DIRECTOR
References:
citation: Cox DJ, Humphrey JW, Merkel RL, Penberthy JK, Kovatchev B. Controlled-release methylphenidate improves attention during on-road driving by adolescents with attention-deficit/hyperactivity disorder. J Am Board Fam Pract. 2004 Jul-Aug;17(4):235-9. doi: 10.3122/jabfm.17.4.235.
Clinical trial NCT00249886: Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Major Depression
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether it is advantageous for adolescents who have recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on the treatment a further 6 months or is it just as helpful to stop the medication after recovery.

The hypothesis is that adolescents with major depression who recover from the 6 to 12 week trial of citalopram will be less likely to have a recurrence of depression over a 6 month period if continued on the citalopram as compared to those who discontinue the medication.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of major Depression.
* Age 13-18.
* A score of \> 16 on the 17 item Hamilton Depression Scale or a score of \> 12 on the 17 items plus a score of \>7 on the atypical items.
* Males and females.
* Outpatient at initiation of double blind treatment phase.
* Ability to give informed consent.

Exclusion Criteria:

* Past or current hypomanic or manic episode.
* Currently meets criteria for a Conduct Disorder.
* Current psychotic symptoms.
* Substance dependence in the last 3 months.
* Significant medical condition that would contraindicate the use of an antidepressant.
* Pregnancy
* Past treatment with Citalopram for major depression

Primary outcomes:
measure: Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Anthony J Levitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06444386: ECGi of SyncAV With MultiPoint Pacing
Official title: Electrocardiographic Imaging of MultiPoint Pacing and SyncAV: Understanding Optimized Programming for Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 30
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: The intended population for this clinical investigation consisted of patients over the age of 18 years who have been previously implanted with an Abbott CRT device capable of SyncAV and MultiPoint Pacing. This clinical investigation enrolled male and female subjects from the general heart failure population. Subjects must have met all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Brief summary: The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging (ECGi) in patients receiving cardiac resynchronization therapy (CRT).


Eligibility criteria: Inclusion Criteria:

* Patients previously implanted with a SyncAV and MPP-enabled Abbott Quadripolar CRT pacing system
* Patient must be \> 18 years of age, able to provide informed consent and willing to comply with study requirements
* Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
* Patient has documented Left Bundle Branch Block (LBBB)

Exclusion Criteria:

* Resting heart rate \> 100 bpm
* AV Block (1st degree with PR\> 250 ms, 2nd or 3rd degree)
* Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
* Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
* Women who are pregnant or plan to become pregnant during the study course

Primary outcomes:
measure: Left ventricular activation time
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
References:
Clinical trial NCT01913886: Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy
Official title: Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ischemic Cardiomyopathy
Keywords: Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Coronary Disease
Ventricular Dysfunction
Arteriosclerosis
Lead sponsor: Pontifícia Universidade Católica do Paraná
Sponsor class: OTHER
Collaborators: name: Santa Casa de Misericórdia de Curitiba, Brazil
name: Fundação Araucária
First posted: 2013-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Detailed description: Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Eligibility criteria: Inclusion Criteria:

* Chronic coronary artery disease
* NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with.
* Ejection fraction between 35% and 55%.
* Stable medical therapy for at least one month
* Patients clinically treated with coronary angioplasty with or without intraluminal stent.
* Patients with surgical revascularization and without the possibility of new invasive intervention.

Exclusion Criteria:

* Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
* An active uncontrolled infection.
* Pregnancy.
* Mental disability.
* Terminal illnesses.
* Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic.
* Life perspective by other diseases under 1 year.
* History of severe arrhythmias
* Renal dysfunction or against medication
* Inability to perform cardiac catheterization.

Primary outcomes:
measure: Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram.
timeFrame: 3 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 3 months, 6 months, 12 months
measure: Changes in exercise capacity
timeFrame: 1 year
measure: Changes in plasma inflammatory markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Pontifícia Universidade Católica do Paraná
state: Paraná
Study officials:
affiliation: Pontifícia Universidade Católica do Paraná
name: Paulo Brofman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201786: Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Official title: Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft-Versus-Host Disease
Keywords: Corticosteroids
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 8
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: This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.


Eligibility criteria: Inclusion Criteria:

* Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
* No chronic GVHD
* Age ≥ 18 years
* Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
* Performance status 0-3

Exclusion Criteria:

* Patients on mechanical ventilation or who have resting O2 saturation \<90% by pulse-oximetry.
* Patients on renal dialysis or who have an estimated creatinine clearance of \< 30 ml/min/1.73 m2.
* Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.

Primary outcomes:
measure: Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
timeFrame: up to 2 years
Secondary outcomes:
measure: Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Craig Hofmeister, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poi MJ, Hofmeister CC, Johnston JS, Edwards RB, Jansak BS, Lucas DM, Farag SS, Dalton JT, Devine SM, Grever MR, Phelps MA. Standard pentostatin dose reductions in renal insufficiency are not adequate: selected patients with steroid-refractory acute graft-versus-host disease. Clin Pharmacokinet. 2013 Aug;52(8):705-12. doi: 10.1007/s40262-013-0064-7.