louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00288379: SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Official title: A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
allergen challenge
airway responsiveness
airway inflammation
Symbicort®
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma


Eligibility criteria: Inclusion Criteria:

* A diagnosed history of asthma for at least 6 months
* Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
* FEV1 \>70% of predicted normal value (post-bronchodilator value).
* Skin prick test positive to pollen, animal dander or house dust mite.

Exclusion Criteria:

* Any significant respiratory disease, other than asthma.
* Upper or lower respiratory tract infection within 4 weeks before inclusion.
* Use of:

  1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
  2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
  3. regular NSAIDs

Primary outcomes:
measure: PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary outcomes:
measure: eNO (ppb).
measure: Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
measure: Total and differential blood cell count
measure: Different Biomarkers
measure: Safety endpoints will be incidence of Serious Adverse Events (SAEs)
measure: Discontinuation due to Adverse Events (DAEs).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00277979: 3D Echocardiography Managing Infantile Pompe's Disease
Official title: Utilization of 3D Echocardiography in the Management of Infantile Pompe's Disease: Two Case Reports
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
Infantile Pompe's Disease
3D Echocardiography
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 2
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: Subject with Infantile Pompe's Disease seen at Children's between Jan. and February, 2005.

Brief summary: Pompe's disease, also known as glycogen storage disease type II, is a genetic disorder due to deficiency of acid glucosidase (GAA), which results in lysosomal glycogen storage in various tissues.

Very low levels of GAA usually present in infancy, lead to a progressive cardiac and skeletal muscle disorder and death before age 1 year.

Most infants develop massive hypertrophic cardiomyopathy which progresses to dilated cardiomyopathy and cardiorespiratory arrest.

3D echocardiography can be a simple, non-invasive method of following cardiac disease progression in infantile Pompe's disease.

Detailed description: We report the utilization of real-time 3D echocardiography and new in-line software to calculate cardiac mass, volume and function in two cases of infantile Pompe's Disease. Furthermore, the multi-dimension cine loop showed the severity of cavity obliteration during the cardiac cycle.

We present 2 cases seen at our institution between January - February, 2005 in infants ages 1 and 5 months, both with cardiac signs as initial presentation. The younger infant had cardiomegaly since birth and was hospitalized briefly for respiratory distress at 1 month. The older infant, diagnosed at 4 months with hypertrophic cardiomyopathy, was hospitalized after cardiac arrest one month later. Both children had various tests done during the course of diagnosis and treatment, including GAA enzyme assay, cardiac catheterization, endomyocardial biopsy, developmental assessment, genetic evaluation, EKG, CXR and echocardiography.

Eligibility criteria: Inclusion Criteria:

* Infant seen at Children's Healthcare of Atlanta, Egleston January - February, 2005 Infantile Pompe's Disease

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Tiffany J Riehle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04808479: Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use
Official title: FOA Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication-Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2021-03-22
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 focus of this study is to examine the effectiveness of imFREE relative to mHealth ED in facilitating treatment retention and adherence and reducing opioid use among adults with OUD initiating BUP treatment.

There are two specific aims: (1) to test the effectiveness of imFREE, delivered in conjunction with medical management with buprenorphine (imFREE + MM), relative to mHealth ED + MM, in facilitating buprenorphine treatment retention and adherence in a population of individuals with OUD initiating MM (N=200). (2) To evaluate the cost-effectiveness of imFREE.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* DSM-5 diagnosis of OUD
* no more than 2 weeks from the date of BUP induction
* able to read and comprehend English at the 6th grade level (determined by REALM)
* able to provide informed consent
* presently owns a mobile phone that can send and receive text messages

EXCLUSION CRITERIA

Participants must not have:

1. Life threatening or unstable medical illness requiring treatment or making participation difficult
2. Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
3. Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).

Primary outcomes:
measure: Medication Adherence self-report form. Unannounced medication count by phone
timeFrame: Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.
Secondary outcomes:
measure: DSM-V Checklist
timeFrame: Baseline
Other outcomes:
measure: European Addiction Severity Index
timeFrame: Baseline, month 3, month 6
measure: Urine drug screen
timeFrame: Throughout six months, monthly
measure: Medical Management (MM) attendance
timeFrame: Throughout six months, monthly
Locations:
city: Tarzana
country: United States
facility: Tarzana Treatment Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Suzette Glasner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550979: Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk
Official title: Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Keywords: gestational diabetes mellitus
cardiovascular disease risk
heart disease risk
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Joslin Diabetes Center
First posted: 2007-10-30
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black and white women who have had uncomplicated pregnancies or pregnancies complicated by gestational diabetes in the past 5 years

Brief summary: The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.


Eligibility criteria: Inclusion Criteria:

* Healthy women of self-identified African descent (black) and European (white) ancestry
* 18-40 years of age
* Regular menstrual cycles
* 5 or less years postpartum
* Have either a normal or a GDM index pregnancy history
* Are in good health free of thyroid, cardiac, or renal disease

Exclusion Criteria:

* If you are pregnant
* If you are lactating

Primary outcomes:
measure: endothelial function
timeFrame: same day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Rhonda Bentley-Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545179: Web-based Daily Care Training of Children With Cerebral Palsy
Official title: Ethics Committee of the University of Social Welfare and Rehabilitation Science
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose:Effect of web-based daily care training on the quality of life of caregivers of children with cerebral palsy.

study design: Single-blind clinical trial. study population: Caregivers of children with cerebral palsy. Inclusion criteria: caregiver -Mother of a child with cerebral palsy who spent most time on child care- Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records. Moderate and severe cerebral palsy (gross motor function levels 3 to 5). caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week). exclusion criteria: taking care of two or more children with disability. participated in previous face to face training programs.

Sample size: 100. Intervention: Web-based daily care training. intervention time: 12-week. Outcome of the study: the quality of life of caregivers

Detailed description: step1: web development and design

1. development of educational content (4 weeks)
2. Create a paper version of the site (2 weeks)
3. Create a web-based version of the site (4 weeks)
4. pilot study (6 weeks) step 2: RCT (12 weeks)

Eligibility criteria: Inclusion Criteria:

* caregiver_ Mother of a child with cerebral palsy who spent most time on child care Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records
* Moderate and severe cerebral palsy (gross motor function levels 3 to 5)
* caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week)

Exclusion Criteria:

* taking care of two or more children with disability
* participated in previous training programs

Primary outcomes:
measure: quality of life of caregivers
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Occupational therapy department, University of Social Welfare and Rehabilitation Sciences
name: Zahra Nobakht, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04301479: Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)
Official title: Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vasoplegia
Cardiac Surgery
Keywords: vasoplegia
cardiac surgery
steroids
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2020-03-10
Enrollment: 140
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: Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB).

Postoperative vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy.

Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain.

This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery with cardiopulmonary bypass
* Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery

Exclusion Criteria:

* Preoperative vasopressor use (within 72 hours prior to surgery)
* Preoperative steroids use (within 7 days prior to surgery)
* Presence of ventricular assist device other than intraaortic ballon pump
* Transplant procedures
* Emergency procedures
* Aortic repairs
* Congenital procedures
* Endocarditis
* Bacterial or fungal infection in the preceding 30 days
* Active neoplasia
* Pregnancy
* Recent history of gastrointestinal bleeding
* Allergy or intolerance to steroids
* Participation in other study

Primary outcomes:
measure: Vasopressors-free days
timeFrame: 30 days
Secondary outcomes:
measure: 30 days mortallity
timeFrame: 30 days
measure: ICU length of stay
timeFrame: 30 days
measure: Infection complication
timeFrame: 30 days
measure: Acute myocardial infarction
timeFrame: 30 days
measure: Atrial fibrillation
timeFrame: 30 days
Other outcomes:
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: Post-operative length of stay
timeFrame: 30 days
measure: Mesenteric ischemia
timeFrame: 30 days
measure: Acute respiratory distress syndrome
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Hyperglycemia
timeFrame: Up to 72 hours
measure: 180 days mortallity
timeFrame: 180 days
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
References:
Clinical trial NCT02766179: Compare Outcomes of SMG and CPAP in OSA
Official title: A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Sleep Apnea Syndromes
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.

Detailed description: The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 2 weeks and Wash-out periods 2 weeks are required before start each treatment.

Eligibility criteria: Inclusion Criteria:

1. OSA patients aged over 18 YO at Siriraj hospital
2. AHI 5 - 30 events/ h or AHI \> 30 events/h but lowest O2 saturation \> 70%
3. Positive consented form

Exclusion Criteria:

1. Patients with severe Temporomandibular joint diseases or limited mandible advancement (\< 5 mm)
2. Patients with severe periodontal diseases or inadequate teeth (\< 3 teeth in each quadrant)
3. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
4. Patients who could not tolerate the side effects of CPAP or SMG
5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.

Primary outcomes:
measure: Quality of life
timeFrame: 6 weeks
Secondary outcomes:
measure: side effects
timeFrame: 6 weeks
measure: satisfaction
timeFrame: 6 weeks
measure: AHI
timeFrame: 6 weeks
measure: Degree of sleepiness
timeFrame: 6 weeks
measure: lowest oxygen saturation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Wish Banhiran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banhiran W, Assanasen P, Nopmaneejumrudlers C, Nujchanart N, Srechareon W, Chongkolwatana C, Metheetrairut C. Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea. Laryngoscope. 2018 Feb;128(2):516-522. doi: 10.1002/lary.26753. Epub 2017 Jul 17.
Clinical trial NCT00842179: Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device
Official title: Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Closure
Keywords: Perclose
Lead sponsor: Clinyx, LLC
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2009-02-12
Enrollment: 2517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who require vascular closure post percutaneous coronary intervention

Brief summary: The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

Detailed description: It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

Eligibility criteria: Inclusion Criteria:

* Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
* Patients who received vascular closure by manual compression at Tampa General Hospital

Exclusion Criteria:

* Patients less than 18 years old

Primary outcomes:
measure: major vascular complications
timeFrame: 0-30 days (during Index hospitalization)
Secondary outcomes:
measure: Minor vascular complications
timeFrame: 0-30 days (during index hospitalization)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Jonathan Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: