louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04155879: Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
Official title: Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-07
Enrollment: 300
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: Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation
* Candidate for cardioversion

Exclusion Criteria:

* Colchicine allergy
* Hepatic or renal failure

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Alpha Defensin levels in patients with recurrence of atrial fibrillation
timeFrame: 12 months
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02935179: The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity
Official title: Office of Human Research, Taipei Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.

Detailed description: All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

Eligibility criteria: Inclusion Criteria:

* 24≦ BMI≦30

Exclusion Criteria:

* Pregnant and lactating women
* Patients within six months after surgery
* Mental illness or depression
* Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases
* Those who have taken "additional nutritional supplements" habit

Primary outcomes:
measure: Body Weight After Intervention
timeFrame: 60 days
Secondary outcomes:
measure: Body Fat After Intervention
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Office of Human Research, Taipei Medical University
name: Chih-Han Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04980079: Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children
Official title: Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ureter Obstruction
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the role of both primary and deferred URS in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study

Detailed description: Thirty group B (30) patients will be admitted to do urinary drainage through the insertion of a JJ stent or percutaneous nephrostomy (PCN) at first , then a deferred URS will be done children will undergo primary URS( group A ) and in. Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy. Postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.

Eligibility criteria: Inclusion Criteria:

* Children ˂12 years with calculus anuria.
* Clinically stable (serum creatinine \< 3.5 mg/dl, blood urea \< 100 mg/dl,serum potassium level \< 7 milliequivalent /L and /or ph of blood \> 7.1)
* All the patients free of sepsis.

Exclusion Criteria:

* Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
* Children with underlying urological structural abnormalities

Primary outcomes:
measure: renal function
timeFrame: one month .
Secondary outcomes:
measure: the stone-free rates
timeFrame: one month
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: Mostafa
Study officials:
affiliation: SVU
name: Mostafa abdelrazek, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00755079: Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
beta-2 agonist
respiratory muscle strength
pulmonary function test
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.


Eligibility criteria: Inclusion Criteria:

* Chronic Spinal Cord Injury (\>1 year post-injury)
* All American Spinal Injury Association (ASIA) classifications
* High Paraplegia (level of injury T1-T6)
* Tetraplegia (level of injury C2-C8, non-ventilator dependent)

Exclusion Criteria:

* history of asthma
* uncontrolled hypertension or cardiovascular disease
* those using beta-2 adrenergic agonists
* epilepsy or seizure disorder
* hyperthyroidism
* chronic corticosteroid use
* those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression
* hypersensitivity to albuterol or any of its' delete components
* pregnancy
* use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:

  * creatine monohydrate
  * anabolic steroids (e.g., testosterone)
  * growth hormone and their analogs and/or derivatives

Primary outcomes:
measure: Inspiratory Respiratory Muscle Strength
timeFrame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Secondary outcomes:
measure: Expiratory Respiratory Muscle Strength
timeFrame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: Greg Schilero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00523679: Symbicort SMART (Symbicort Maintenance And Reliever Therapy)
Official title: SMART (Symbicort Maintenance And Reliever Therapy): Reassure Program for Patients Using Symbicort Turbuhaler as Maintenance and Reliever Therapy in Korean Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Symbicort
SMART
inhaler
compliance
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital Outpatient Clinics

Brief summary: The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy.


Eligibility criteria: Inclusion Criteria:

* Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program.

Exclusion Criteria:

* Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Joon-Woo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT04393779: Observational Registry on the HARPOON Device
Official title: Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Keywords: Mitral valve
Mid-segment posterior leaflet prolapse of the mitral valve
Heart valve
Chordae tendinae
Valve disease
Mitral Regurgitation
Harpoon
Mitral valve repair
Posterior leaflet prolapse
Beating heart intervention
Heart disease
Cardiovascular disease
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2020-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: TREATMENT

Brief summary: To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

Detailed description: This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
timeFrame: 1 year post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
state: Baden-Württemberg
city: Bad Neustadt
country: Germany
facility: Rhön Klinikum Kardiochirurgie
state: Bayern
city: Passau
country: Germany
facility: Klinikum Passau
state: Bayern
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Niedersachsen
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
state: Nordrhein-Westfalen
city: Palma
country: Spain
facility: Hospital Son Espases
state: Illes Balears
city: Bern
country: Switzerland
facility: Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern
Study officials:
affiliation: Goethe University
name: Thomas Walther, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962879: Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
Official title: Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Psychotic Disorders
Depressive Disorder
Psychosocial Functioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 70
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled in 9th through 12th grade and between the ages of 14 and 19
* Endorsed at least one psychotic experience
* Provided contact information
* Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)
* Have a parent or legal guardian who is able and willing to participate in a parent session
* Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)
* Able to communicate in English

Exclusion Criteria:

* Currently prescribed psychotropic medication (not including medications for attention deficit/hyperactivity disorder), regardless of adherence
* Currently obtaining psychotherapeutic intervention

Primary outcomes:
measure: Structured Interview of Psychosis-risk Syndromes (SIPS)
timeFrame: 1 year
Secondary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: 1 year
measure: Global Functioning Social and Role Scales
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00329979: Femoral vs Radial Approach and MRI Evaluation of Strokes
Official title: Silent Cerebral Infarction After Heart Catheterization: A Randomized Comparison of Radial and Femoral Arterial Access.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: aortic stenosis
radial
femoral
vascular access site
embolism
cerebral
MRI
stroke
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2006-05-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with aortic stenosis

Brief summary: Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI.

Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.


Eligibility criteria: Inclusion Criteria:

* Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria:

* Contraindication to MRI or inability to give written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen, cardiology department
Study officials:
affiliation: CHU CAEN
name: Michèle Hamon, MD
role: STUDY_CHAIR
affiliation: CHU CAEN
name: Martial Hamon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05129579: Psychological Resilience and Psychological Well-being of Intensive Care Nurses
Official title: The Effect of the Mindfulness Based Stress Reduction Intervention on Psychological Resilience and Psychological Well-being of Intensive Care Nurses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Resilience
Well-being
Keywords: Mindfulness
Intensive Care Nurses
Lead sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses.

Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.

Hypotheses: H1: The resilience level scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the nurses in the control group.

H2: Nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase their well-being level scores compared to the nurses in the control group.

H3: The psychological resilience level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores.

H4: The well-being level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.


Eligibility criteria: Inclusion Criteria:

* Having Having a working time of at least 6 months in the intensive care unit,
* No barriers to accessing technology for participation in the online training program,
* Absence of a communication barrier related to vision and hearing

Exclusion Criteria:

* Working in the intensive care unit for less than 6 months
* Working in the intensive care unit due to temporary assignment

Primary outcomes:
measure: Psychological Resilience Level
timeFrame: for 3 months
measure: Psychological Well-being Level
timeFrame: for 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00350779: Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and a PPARg Agonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.


Eligibility criteria: Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is inadequately controlled while taking two oral antidiabetic medications

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient required insulin therapy within the prior 3 months
* Patient has been taking Byetta (R) (exenatide) within the prior 3 months

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18
timeFrame: Baseline and 18 Weeks
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18
timeFrame: Baseline and 18 Weeks
measure: Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18
timeFrame: Baseline and Week 18
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
timeFrame: Baseline and Week 54
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
timeFrame: Baseline and Week 54
measure: Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54
timeFrame: Baseline and Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Dobs AS, Goldstein BJ, Aschner P, Horton ES, Umpierrez GE, Duran L, Hill JS, Chen Y, Golm GT, Langdon RB, Williams-Herman DE, Kaufman KD, Amatruda JM, Ferreira JC. Efficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo-controlled 54-week trial in patients with type 2 diabetes. J Diabetes. 2013 Mar;5(1):68-79. doi: 10.1111/j.1753-0407.2012.00223.x.