louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00344968: Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Official title: A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 956
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: This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years with diabetic macular edema
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of 19-68 letters
* Retinal thickness \> 250 micron by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within 6 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole

Primary outcomes:
measure: Visual Acuity
timeFrame: 36 months
Secondary outcomes:
measure: Retinal Thickness
timeFrame: 36 months
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
Study officials:
References:
citation: Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
citation: Holden SE, Kapik B, Beiderbeck AB, Currie CJ. Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials. Curr Med Res Opin. 2019 Jul;35(7):1165-1176. doi: 10.1080/03007995.2018.1560779. Epub 2019 Jan 17.
Clinical trial NCT01813968: Ischemic Postconditioning in Cardiac Surgery
Official title: Ischemic Postconditioning in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Ischemic postconditioning
Adult cardiac surgery
Aortic valve surgery
Swan-Ganz
Cardiac index
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
name: University Hospital of North Norway
name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
First posted: 2013-03-19
Enrollment: 209
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.

Detailed description: Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients \> 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.

The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.

Eligibility criteria: Inclusion Criteria:

Patients undergoing elective surgery of the ascending aorta or the aortic valve

-

Exclusion Criteria:

* Coronary artery disease requiring bypass surgery
* Tricuspid valve surgery
* Mitral valve surgery
* Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
* Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
* Patients with autoimmune diseases
* "Redo" operations
* Active endocarditis (ongoing antibiotic therapy)
* On the discretion of the operating surgeon or anaesthesiologist

Primary outcomes:
measure: Change in cardiac index between the groups during the first postoperative day
timeFrame: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål
Study officials:
References:
Clinical trial NCT02601768: Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment
Official title: Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ostium Secundum Atrial Septal Defect
Keywords: ASD II
transcatheter closure
percutaneous closure
3D TEE
balloon-sizing
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 consecutive adult patients with ASD II closed percutaneously in our center in the study time frame i.e.

Brief summary: The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.

Detailed description: A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* ASD II suitable for percutaneous treatment
* free and informed consent to analyze the medical data of the person concerned
* age: patients over 16

Exclusion Criteria:

* ASD II not suitable for percutaneous treatment
* any valvular heart disease requiring cardiac surgery
* no free and informed consent to analyze the medical data of the person concerned
* age: under 16

Primary outcomes:
measure: Correlation between the proposed and actual device size.
timeFrame: 18 months
Secondary outcomes:
measure: Success rate of the procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute Of Cardiology
Study officials:
affiliation: Institute Of Cardiology in Warsaw
name: Jan Henzel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00001746: Screening for Inherited Heart Disease
Official title: Evaluation of Patients With Known or Suspected Inherited Heart Disease (Screening Protocol)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy
HCM
Evaluation for Research
Medical Advice
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Genetically inherited heart diseases like hypertrophic cardiomyopathy (HCM) are conditions affecting the heart passed on to family members by abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses.

Presently, there are several research studies being conducted in order to improve the understanding of disease processes and symptoms associated with genetically inherited heart diseases.

This study is designed to determine the eligibility of patients diagnosed with or suspected to have inherited heart disease to participate in these research studies.

Detailed description: Patients with hypertrophic cardiomyopathy (HCM) and other inherited cardiac diseases are being studied under several research protocols to determine their pathogenesis and clinical manifestations. The purpose of this protocol is to determine the eligibility of patients with known or suspected inherited heart conditions for our research protocols.

Eligibility criteria: INCLUSION CRITERIA

Subjects and family members known or suspected to have inherited a cardiac disease such as HCM.

EXCLUSION CRITERIA

Patients with cardiac conditions that are not known to be inherited.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Maron BJ, Bonow RO, Cannon RO 3rd, Leon MB, Epstein SE. Hypertrophic cardiomyopathy. Interrelations of clinical manifestations, pathophysiology, and therapy (1). N Engl J Med. 1987 Mar 26;316(13):780-9. doi: 10.1056/NEJM198703263161305. No abstract available.
citation: Wigle ED, Rakowski H, Kimball BP, Williams WG. Hypertrophic cardiomyopathy. Clinical spectrum and treatment. Circulation. 1995 Oct 1;92(7):1680-92. doi: 10.1161/01.cir.92.7.1680.
citation: Solomon SD, Jarcho JA, McKenna W, Geisterfer-Lowrance A, Germain R, Salerni R, Seidman JG, Seidman CE. Familial hypertrophic cardiomyopathy is a genetically heterogeneous disease. J Clin Invest. 1990 Sep;86(3):993-9. doi: 10.1172/JCI114802.
Clinical trial NCT01554046: The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder Combined Type
ADHD Predominantly Inattentive Type
ADHD Predominantly Hyperactivity Type
ADHD-not Other Specified
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Methylphenidate- RITALIN IR (Immediate Release)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
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 investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development.

Detailed description: Attention Deficit/Hyperactivity Disorder (ADHD) is very prevalent and tends to continue from childhood to adult life. It's heritability is 76%. It was found that there is a greater ADHD prevalence in first-degree families of ADHD subjects- 4-6 times more than the general population.

Pharmacological treatment is the first line treatment today in ADHD, in children and adults, and Methylphenidate (specially Ritalin IR) is the first medication given for the disorder.

The study includes couples of first-degree family members, both diagnosed with ADHD. Subjects will receive Ritalin IR for 4 weeks and undergo several psychiatric and cognitive questionnaires at each time of the follow-up meeting (a total of 3).

Eligibility criteria: Inclusion Criteria:

* couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.

Exclusion Criteria:

* subjects who receive other psychiatric medications: antipsychotic medications, antidepressants medications, anti-anxiety medications or mood stabilizers.
* people who suffer from psychotic disorder, bipolar disorder or other severe psychiatric disorders which are not stabilized.
* Alcohol/drugs addicted.
* people with chronic neurologic diseases.
* people with Autism or mental retardation.
* people with congenital heart defect.
* people with hypertension/tachycardia (\>100 bpm).
* pregnancy or breast feed women.

Primary outcomes:
measure: Clinical Global Impression-Improvement scale
timeFrame: CGI scale score at 4 weeks <=2
Secondary outcomes:
measure: overall ADHD-Rating Scale (ADHD-RS) score
timeFrame: change from baseline in ADHD-RS at 2 weeks (reducing >30%), change from baseline in ADHD-RS at 4 weeks (reducing >30%)
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Prof. Doron Gothelf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01703546: Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
Official title: Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Weight Loss Surgery
Laparoscopic Adjustable Gastric Band
Laparoscopic Gastric Plication
Imbrication
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 420
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: The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Detailed description: Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) \> 35
* Meet ASMBS and NIH criteria for Weight Loss Surgery
* ASA Class I - III
* Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
* English speaking \& comprehension
* Normal mental caliber.

Exclusion Criteria:

* Pregnancy, Liver failure or Kidney failure
* Women of childbearing potential lactating at the time of initial consult or at the time of surgery
* Any condition which precludes compliance with the study
* History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.

Primary outcomes:
measure: % Excess Body Weight Loss (%EWL)
timeFrame: 6 months post procedure
Secondary outcomes:
measure: HgbA1c
timeFrame: 12 months post procedure
Other outcomes:
Locations:
city: Syosset
country: United States
facility: Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
state: New York
city: Syosset
country: United States
facility: Syosset Hospital, Center for Bariatric Surgical Specialties
state: New York
Study officials:
affiliation: North Shore LIJ Health System, Syosset Hospital, Director of Surgery
name: Robert Ward, MD
role: STUDY_CHAIR
affiliation: North Shore LIJ Health System Syosset Hospital
name: Allison Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090946: The Experiences of Parents Learning Physiotherapy Techniques for Their Child
Official title: The Experiences of Parents Learning Physiotherapy Techniques for Their Child
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Disabilities
Keywords: children with physical disabilities
home activity programs
home programmes
learning
therapeutic relationship
phenomenology
physiotherapy
clinicians who teach
parent perspective
parent-professional relationships
Parents/carers
long term physiotherapy needs
Lead sponsor: Western Sussex Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Brighton & Sussex Medical School
First posted: 2014-03-19
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: convenience sample from the Arun, Adur and Worthing region, UK.

Brief summary: The experiences of learning from paediatric physiotherapists were explored through unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic phenomenological study, six parents responsible for a physiotherapy home programme for their child were selected through convenience sampling. The purpose of this study was to obtain rich and valid information that could be analysed. The phenomenon of their learning experiences was formed and explored, its implications discussed and inferences made in light of current physiotherapy service delivery.


Eligibility criteria: Inclusion Criteria:

* parent/main carer of a child with a long term physical condition receiving physiotherapy in the United Kingdom for at least six months.

Exclusion Criteria:

* parents experiencing physiotherapy outside UK practice.
* parents to whom English is not their first language.
* parents under 16 years of age

Primary outcomes:
measure: the learning experiences of parents
timeFrame: after six months of physiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Worthing
country: United Kingdom
facility: Western Sussex Hospitals NHS Foundation Trust
state: West Sussex
Study officials:
affiliation: Western Sussex Hospitals NHS Foundation Trust
name: Deborah Wilson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson, D. The learning Experiences of Parents whose Children require Physiotherapy Intervention. The Association of Paediatric Chartered Physiotherapists Journal 4 (2): 68, Nov, 2013
Clinical trial NCT00880646: Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity
Official title: Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity: a Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Unitika Ltd.
First posted: 2009-04-14
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI between 25 and 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction

Primary outcomes:
measure: Body mass index
timeFrame: 20 weeks
Secondary outcomes:
measure: Body fat mass
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Abdominal circumference
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Visceral fat area by CT scan
timeFrame: Week 0, Week 12
measure: Serum lipid profile
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Serum adiponectin and leptin levels
timeFrame: Week 0, Week 12
measure: Fasting serum glucose and HbA1c levels
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Frequency of bowel movement
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
References: