louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01558830: Safety of Amiodarone and Ranolazine Together in Patients With Angina
Official title: Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Stable Angina
Coronary Artery Disease
Atrial Fibrillation
Ventricular Tachycardia
Keywords: amiodarone
ranolazine
safety
arrhythmia
Lead sponsor: Cardiovascular Consultants of Nevada
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2012-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.


Eligibility criteria: Inclusion Criteria:

* ischemic cardiac disease
* chronic anginal symptoms
* on amiodarone therapy for other cardiac conditions

Exclusion Criteria:

* pregnant
* non-English speaking
* unstable angina
* baseline electrocardiogram (EKG) corrected QT (QTc)\>490ms
* severe thyroid dysfunction
* heart block without a pacer system
* liver disease

Primary outcomes:
measure: ventricular arrhythmia
timeFrame: 3 months
Secondary outcomes:
measure: atrial arrhythmia burden
timeFrame: 3 months
measure: Electrocardiogram (EKG) corrected QT (QTc) interval measurement
timeFrame: over the 3 month trial
measure: hospitalization
timeFrame: 3 months
measure: syncope hospitalization
timeFrame: 3 months
measure: liver function assay
timeFrame: 3 months
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Cardiovascular Consultants of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Cardiovascular Consultants of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Cardiovascular Consultants of Nevada
state: Nevada
Study officials:
affiliation: Cardiovascular Consultants of Nevada
name: Erik J SIrulnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176630: Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
Official title: Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome, ESRD patient
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study subjects are on maintenance hemodialysis

Brief summary: The study is a survey to answer the specific question, "What is the prevalence of metabolic syndrome in maintenance hemodialysis patients?" Metabolic syndrome is a cluster of conditions that increase an individual's risk for developing cardiovascular disease and diabetes.

Detailed description: Risk factors for metabolic syndrome will be collected for each consented patient. They include elevated serum triglycerides, reduced HDL cholesterol, hypertension, elevated fasting blood sugar concentration and abdominal obesity. The investigator will measure waist circumference of each consented patient in a secure area according to standardized procedures. The other data is available from the patient's medical record.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing maintenance hemodialysis equal to or greater than 3 months
* Patient at lest 18 years of age
* Availability of all data in the medical record for classification of the metabolic syndrome, including serum triglycerides, serum HDL-cholesterol, systolic BP and diastolic BP, and serum glucose

Exclusion Criteria:

* Patients unwilling or unable to give informed consent to participate
* Patients with a history of thyroid disease
* Patients unable to stand upright

Primary outcomes:
measure: Percent of maintenance patients with at least three risk factors of metabolic syndrome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital Outpatient Dialysis Unit
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Mary Schanler, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159730: Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biomarker
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, ≥18 to ≤75 years of age;

Exclusion Criteria:

* Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
* Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, \[including hepatitis B or C, HIV\], bacterial infections, systemic fungal infections, or syphilis);
* Subjects with a history of coronary events within the last 6 months;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: VBL Investigative Site
state: Scotland
Study officials:
References:
Clinical trial NCT01107730: Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
Official title: Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Cardiac valve repair
Aneurysm repair
CABG
On-pump
Cardiac surgery
Vitamin C
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

Detailed description: Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing on-pump cardiac surgery

Exclusion Criteria:

* Off-pump cardiac surgery procedure
* AF before the procedure
* Recent infection and/or infectious endocarditis
* Presence of neoplasia
* Chronic renal failure with creatinine\>2.3 mg/dl
* Hepatic failure
* Autoimmune disease and/or disease that brings about a systematic inflammatory response
* Thyroid disease
* Systematic use of supplements that contain vitC or carnitine
* The use of NSAIDs other than aspirin for a time period up to one month before the procedure

Primary outcomes:
measure: Incidence of Postoperative Atrial Fibrillation
timeFrame: Within the first 30 days (plus or minus 3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University General Hospital Attikon
Study officials:
affiliation: University of Athens Medical School, Attikon Hospital, Cardiology Department
name: Ioannis Toumpoulis, MD
role: STUDY_CHAIR
References:
citation: Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larrain E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: 10.1016/j.ijcard.2009.04.043. Epub 2009 May 15.
Clinical trial NCT00184730: Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Official title: Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.


Eligibility criteria: Inclusion Criteria:

* Subjects who completed GHLiquid-1519.
* If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.
* Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.

Exclusion Criteria:

* Subject with a history of acromegaly.
* Subject with diabetes mellitus.
* Subject suffering from malignancy.
* Several medical conditions

Primary outcomes:
measure: Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)
timeFrame: at the end of treatment
measure: GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio)
timeFrame: at the end of treatment
Secondary outcomes:
measure: Adverse events
measure: FPG, insulin, and HbA1C
measure: Clinical laboratory tests
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01216930: Molecular Screening for Lynch Syndrome in Southern Denmark
Official title: Molecular Screening for Lynch Syndrome in Southern Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lynch Syndrome
HNPCC
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 2000
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: All colorectal cancer patients in the geographical region of southern Denmark

Brief summary: A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark.

Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling.

The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone.

Prospective data collection is performed using established clinical databases.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of colorectal adenocarcinoma
* Diagnosed at one of the five departments of pathology in the region

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Department of Pathology
city: Odense
country: Denmark
facility: Department of Clinical Genetics
city: Odense
country: Denmark
facility: Department of Pathology
city: Svendborg
country: Denmark
facility: Department of Pahology
city: Sønderborg
country: Denmark
facility: Department of Pathology
city: Vejle
country: Denmark
facility: Department of Clinical Genetics
city: Vejle
country: Denmark
facility: Department of Pathology
Study officials:
References:
Clinical trial NCT03788330: Short-term Health Benefits of Using Fresh Air Filtration System in Classroom
Official title: Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Cognitive and Attention Disorders and Disturbances
Oxidative Stress
Keywords: exhaled nitric oxide
Sick building syndrome
indoor air
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 94
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.

Detailed description: A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.

Eligibility criteria: Inclusion Criteria:

* All invited primary school children in Grade 5 in an artibrarily selected school

Exclusion Criteria:

* Current airway symptoms (cough, airway infection, asthma et al.)
* Acute infectious diseases

Primary outcomes:
measure: Exhaled nitric oxide
timeFrame: within 2 hours of the end of intervention in each week
measure: Oxidative stress biomarkers
timeFrame: within 2 hours of the end of intervention in each week
measure: Sick building symdrom
timeFrame: within 2 hours of the end of intervention in each week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
Study officials:
affiliation: Fudan University
name: Zhuohui Zhao, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01343030: Prospective Radiologic Evaluation of Changes Following Fat Grafting
Official title: Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: The Institute for Basic and Applied Research in Surgery
name: Mentor Worldwide, LLC
name: Clinique SPONTINI
First posted: 2011-04-27
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will select patients from Clinique Spontini Paris France and from patients at the University of Minnesota USA who have undergone placement of silicone breast implants with fat grafting.

Brief summary: Breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. The investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images.

Hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Women with silicone implants and fat grafting

Exclusion Criteria:

* Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France

Primary outcomes:
measure: Radiologist dictations of mammograms
timeFrame: We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Paris
country: France
facility: Clinique SPONTINI
Study officials:
affiliation: University of Minnesota
name: Bruce L Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180330: The Impact of Water Activities on Motor Development in Infants
Official title: The Impact of Water Activities on Motor Development in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Keywords: swimming
motor development
infant
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 43
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will be conducted at various city swimming pools in Warsaw. The study participants will include 20 infants participating in aquatic baby classes once a week and 20 infants not participating in any classes and their parents. The study will be conducted in a quiet and calm room, which will be prepared in advance and equipped with a smooth mat, a lounger and infant toys. The estimated time to conduct the study is about 30 minutes.

The examination will be carried out twice: before the start of the two-month course and after its completion. Each time in the presence of a parent or legal guardian, after signing a consent form for the study.

The selected methods of assessing motor development are fully non-invasive and consist of the following tests:

1. Alberta Infant Motor Scale (AIMS)-a test involving observation of motor development, in which each activity is assessed as existing or not. The sum of the scores from all trials is then placed on a centile grid, the results of which will indicate how many children of a certain age are achieving a given level of motor skills.
2. Early Motor Development Questionnaire (EMQ)-will be conducted on the basis of a ready-made form and in an anonymous manner based on parents' current knowledge of their children's development.


Eligibility criteria: Inclusion Criteria:

* infants age 3-12 months

Exclusion Criteria:

* any disability that would affect motor development

Primary outcomes:
measure: Change from Baseline in the Alberta Infant Motor Scale (AIMS) at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from Baseline in the Early Motor Development Questionnaire (EMQ) at 8 weeks
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Jozef Pilsudski University of Physical Education in Warsaw
Study officials:
References:
Clinical trial NCT01952925: Combined Afib Ablation and RA Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension
Official title: Combined Atrial Fibrillation Ablation and Renal Artery Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Afib
Hypertension
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to perform renal artery denervation at the same time as atrial fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a successful atrial fibrillation ablation, and decrease the number of medications required to control blood pressure.


Eligibility criteria: Inclusion Criteria:

* Hypertensive patients scheduled for afib ablation
* Patient taking one or more BP medication

Exclusion Criteria:

-

Primary outcomes:
measure: change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments
timeFrame: 1 to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Charles Henrikson, MD
role: PRINCIPAL_INVESTIGATOR
References: