louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04523194: Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Official title: Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Tsuchiura Kyodo General Hospital
First posted: 2020-08-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.

Brief summary: The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.

Detailed description: The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. About one thousand patients who underwent coronary angiography with OCT and had a CTA prior to catheterization at Tsuchiura Kyodo General Hospital (TKGH) in Japan, will be included. A subset of these patients also had CMR. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.

Eligibility criteria: Inclusion Criteria:

* Had CTA prior to cardiac catheterization and then OCT during catheterization

Exclusion Criteria:

-

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Ik-Kyung Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Araki M, Sugiyama T, Nakajima A, Yonetsu T, Seegers LM, Dey D, Lee H, McNulty I, Yasui Y, Teng Y, Nagamine T, Kakuta T, Jang IK. Level of Vascular Inflammation Is Higher in Acute Coronary Syndromes Compared with Chronic Coronary Disease. Circ Cardiovasc Imaging. 2022 Nov;15(11):e014191. doi: 10.1161/CIRCIMAGING.122.014191. Epub 2022 Nov 3.
citation: Nakajima A, Sugiyama T, Araki M, Seegers LM, Dey D, McNulty I, Lee H, Yonetsu T, Yasui Y, Teng Y, Nagamine T, Nakamura S, Achenbach S, Kakuta T, Jang IK. Plaque Rupture, Compared With Plaque Erosion, Is Associated With a Higher Level of Pancoronary Inflammation. JACC Cardiovasc Imaging. 2022 May;15(5):828-839. doi: 10.1016/j.jcmg.2021.10.014. Epub 2021 Nov 8.
Clinical trial NCT00654394: Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects
Official title: Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Artery Stenosis
Hypercholesterolemia
Keywords: Cholesterol
Carotid Artery Stenosis
Hypercholesterolemia
Rosuvastatin
Crestor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 200
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: The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* Fasting blood low density lipoprotein cholesterol level as defined by the protocol
* Diagnosed carotid arterial stenosis

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Heavy or total occlusion of the carotid artery or recent stroke
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Primary outcomes:
measure: Changes in carotid wall volume as measured by MRI scan
timeFrame: At 40 weeks and 104 weeks
Secondary outcomes:
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 2 weekly for first 4 weeks then 4 weekly
measure: Other changes in the structure and composition of the carotid arterial wall as defined in the protocol.
timeFrame: At 40 weeks and 104 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington, USA
name: Tom Hatsukami
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT00394394: Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril
Official title: Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2006-11-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent.

This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.


Eligibility criteria: Inclusion Criteria:

* patients who are using Hydrochlorothiazide 25mg/d at least in a four weeks treatment and had their office blood pressure not controlled (systolic or diastolic greater than 140 mmHg or 90 mmHg, respectively).

Exclusion Criteria:

* Established cardiovascular disease
* Diabetics in use of insulin
* Impairment renal in renal function
* Contraindications for the study medications

Primary outcomes:
measure: Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up
Secondary outcomes:
measure: Percentage of patients who needed to double the dose of enalapril or amiloride in forth or eighth week or use propranolol in the eighth week follow-up visiting.
measure: Fasting blood glucose differences between the baseline and twelve-week follow-up visiting.
measure: Serum potassium differences between the baseline and twelve-week follow-up visiting.
measure: Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.
measure: Serum uric acid differences between the baseline and twelve-week follow-up visiting.
measure: Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Miguel Gus
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerrero P, Fuchs FD, Moreira LM, Martins VM, Bertoluci C, Fuchs SC, Gus M. Blood pressure-lowering efficacy of amiloride versus enalapril as add-on drugs in patients with uncontrolled blood pressure receiving hydrochlorothiazide. Clin Exp Hypertens. 2008 Oct;30(7):553-64. doi: 10.1080/10641960802441906.
Clinical trial NCT03740594: Effect of KMC on Neurobehavior of Preterm Neonates
Official title: Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Neurobehavior
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.


Eligibility criteria: Inclusion Criteria:

* Stable preterm neonates with gestational age between 31 and 35 weeks.

Exclusion Criteria:

* Neonates with major congenital birth defects or chromosomal anomalies.
* Perinatal asphyxia and intra-ventricular hemorrhage.
* Hemodynamically significant cardiac abnormalities.
* Neonates received postnatal steroids.
* Neonates whose mothers had a history of drug abuse during pregnancy.

Primary outcomes:
measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
timeFrame: the age of 36 weeks
measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
timeFrame: the age of 36 weeks
Secondary outcomes:
measure: Salivary cortisol
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02242994: Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 5
Sex: ALL
Minimum age (years): 7
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 purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 7 years old - 21 years old
* been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.
* are able to communicate through written words
* are able to follow a 3- steps directions, and follow study directions and procedures.

Exclusion Criteria:

-

Primary outcomes:
measure: Speed of Communication
timeFrame: Immediately
Secondary outcomes:
measure: Error Rate of Communication
timeFrame: At time of experiment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National
state: District of Columbia
Study officials:
References:
Clinical trial NCT02582294: Fabry's Disease and Pregnancy (PREFAB)
Official title: Description of Obstetrical Care, Mainly Anesthesic, in Patients With Fabry's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fabry's Disease
Pregnancy
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fabry's disease patients having had at least one childbirth

Brief summary: Fabry's disease is a progressive systemic disease X-linked which combines neurological (Fabry's pain crises), dermatologic (angiokeratomas), renal (renal failure), cardiovascular (hypertrophic cardiomyopathy, valvular disease, conduction disorder, coronary heart disease) and cerebral vascular (stroke) symptoms .

It is a glycosphingolipid metabolism disorder due to deficient or absent activity of the alpha-galactosidase A, causing accumulation of globotriaosylceramide in the lysosomes.

The incidence is estimated being 1/40 000. Some patients suffering from Fabry's disease today are of childbearing age and their multidisciplinary care (by neurologists, obstetricians and anesthetists) raises several questions.

About the anesthetic, the question of epidural block is debated in patients with neurological diseases and recommendations are not unequivocal.

Indeed one of the problems of the management in those conditions is the potential worsening of the disease because of the anesthetic procedure. In addition, the possibility of an antiplatelet and / or an anticoagulant treatment in these patients may also contre-indicate an epidural block.

The rate of epidural block achieved in patients with Fabry's disease is not currently known. Moreover, only sparse data on pregnancy outcomes in these patients are reported.


Eligibility criteria: Inclusion Criteria:

* Fabry's disease patients, aged 18 years or more, having had at least one childbirth

Exclusion Criteria:

* Patient under a legal protection procedure
* Patient denying to participate to the study
* Lack of affiliation to a social security system

Primary outcomes:
measure: Proportion of Fabry's disease patients having had an epidural block in childbirth.
timeFrame: The duration of the interview for this study with women with Fabry disease's will be one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Diaconesses Croix Saint Simon
state: Ile De France
Study officials:
References:
Clinical trial NCT00719394: Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males
Official title: Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-136 Administered Orally to Healthy Japanese Male Subjects and Healthy Japanese Elderly Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy
Keywords: alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for the treatment of Alzheimer disease. This study will take place in Japan only and will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSI-136 after administration of ascending single oral doses to healthy Japanese male subjects and healthy Japanese elderly male subjects.


Eligibility criteria: Inclusion Criteria .

1. Men aged 20 to 45 years, or greater than 65 years, inclusive, at screening and who agree to use a medically acceptable form of contraception during the study and to continue its use for 12 weeks after test article administration.
2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory tests, vital sign measurements and 12-lead electrocardiogram (ECG).

Exclusion Criteria

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).

Primary outcomes:
measure: Safety and tolerability of GSI-136 as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, orthostatic vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics as evaluated from the blood and urine concentrations of GSI-136; Pharmacodynamics as evaluated from the levels of select biomarkers in the blood and the administration of a visual analog scale to measure sedation effects.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Heat Center
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01300494: BOVAS: Bifurcation Optimal Viewing Angle Selection Study
Official title: Bifurcation Optimal Viewing Angle Selection Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Bifurcation Lesion
Keywords: bifurcation lesion
optimal viewing angle
automated software
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2011-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In patients undergoing coronary angiography, those with an angiographically significant bifurcation lesion will be identified. A total of 50 patients will be selected. After diagnostic angiography, optimal viewing angles for the bifurcation lesion will be calculated using the dedicated Medis (Leiden, the Netherlands) software.

Brief summary: An optimal angiographic viewing angle is critical for correct diagnosis and intervention in coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve the selection of the best viewing angle.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years of age
* Informed consent available

Exclusion Criteria:

* Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
* Impaired renal function (serum creatinine \> 2.0 mg/dl)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02122094: Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Official title: Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Chlamydia
Gonorrhea
Syphilis
Hepatitis C
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Hanoi Medical University
name: University of Puerto Rico
First posted: 2014-04-24
Enrollment: 1166
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.

Detailed description: The intervention is administered in community and clinic settings. The full intervention consists of seven core modules: Sexual Health, Sexual Diversity, HIV/STI Transmission, Behavioral Risk and Risk Reduction, Alcohol and Drugs, Stigma, and HIV/STI and Health Seeking Practices. In the community, outreach is conducted by Health Educators to deliver the intervention modules that young men express and interest in, as well as to provide risk reduction materials including condoms and lubricant. Study interviewers conduct a cross-sectional interview of young male sex workers in community venues (the interviewers and health educators are never present in a venue at the same time), and a random sample of interviewees are invited to a local clinic, where they receive a more detailed interview, the full intervention (delivered one on one by a Health Educator and including all seven modules), a clinical exam, testing for HIV and other STIs (HBV, HCV, gonorrhea, syphilis, chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.

Eligibility criteria: Inclusion Criteria:

* Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days

Exclusion Criteria:

* inability to provide informed consent

Primary outcomes:
measure: Acceptance of testing
timeFrame: 2 hours
measure: Return for test results
timeFrame: two weeks
measure: Intention to access health services
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
city: Ho Chi Minh City
country: Vietnam
facility: Center for Applied Research on Men and Health (CARMAH)
Study officials:
References: