louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00651768: Titratable Dosing in Moderate to Severe Asthmatics
Official title: A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
adults
adolescents
safety
Symbicort
budesonide/formoterol
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 570
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
* Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

Primary outcomes:
measure: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.
timeFrame: 7 assessments within 12 month treatment period
Secondary outcomes:
measure: To measure changes in lung function tests, patient reported outcomes and usage of medical resource
timeFrame: 7 assessments within 12 month treatment period
measure: Blood levels of budesonide and formoterol
timeFrame: 10 blood samples taken at 1 visit in a sub-set of patients
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_DIRECTOR
References:
Clinical trial NCT03704168: Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders
Official title: Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sialorrhea
Neurologic Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 2
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: To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.

Secondary Objective: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.

Duration:

Estimation for Recruitment: 12 months Estimation for Procedure/Trial: 1 visit with an overnight observation Estimation for Subject Follow Up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation Total Expected Duration for Clinical Trial: 2 years


Eligibility criteria: Inclusion Criteria:

1. Written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure
2. Male or female 2 to 65 years of age
3. Confirmed diagnosis of sialorrhea as documented in their medical record
4. Clinically stable with no significant changes in health status in the 2 weeks before the ablation
5. Patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record

Exclusion Criteria:

1. Open sores/ulcers on skin overlying the submandibular glands
2. Contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias
3. Upper respiratory airway obstruction, e.g: severe dystonia
4. History of previous local surgery
5. Any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location
6. Patients that have received salivary gland Botulinum toxin injections within the prior 3 months
7. Subjects unlikely to complete the study as determined by the principle investigator

Primary outcomes:
measure: To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05240768: Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.
Official title: Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 345
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mean age of study population was 62 ±11 years and majority (71%) of the population was male.76% (263) of the population was hypertensive, diabetes mellitus and dyslipidemia was present in 49%(169) and 53%(185) respectively. History of myocardial infarction (MI) was present in 12% (43) and one-fourth of population had history of revascularization, i.e PCI (19%) or coronary artery bypass grafting(CABG) 3%.

Brief summary: The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Detailed description: Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration.

This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR.

Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Eligibility criteria: Inclusion Criteria:

* Patients who had intermediate to severe coronary lesions on coronary angiogram.
* Patients who had negative FFR \>0.80 or iFR \>0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.

Exclusion Criteria:

* Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
* Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.

Primary outcomes:
measure: Cardiac death
timeFrame: 29 months
measure: Non-fatal myocardial infarction
timeFrame: 29 months
measure: Target vessel revascularization.
timeFrame: 29 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT05750368: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Official title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epigastric Hernia
Women With Epigastric Hernias
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2023-03-01
Enrollment: 3031
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing ventral hernia repair in Denmark.

Brief summary: The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.

Detailed description: Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.

The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.

Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).

Eligibility criteria: Inclusion Criteria:

* All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.

Exclusion Criteria:

* umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.

Primary outcomes:
measure: operation for recurrence
timeFrame: 4 year
Secondary outcomes:
measure: Readmittance
timeFrame: 90 days
measure: operation for complications
timeFrame: 90 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT06120868: Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites
Official title: Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Dental Caries
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: a randomized controlled split-mouth study.
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.


Eligibility criteria: Inclusion Criteria:

* Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
* Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
* Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
* Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
* Absence of parafunctional habits.
* Good general health

Exclusion Criteria:

* Serious medical disorders
* Clinical signs of bruxism, traumatic malocclusion
* Pregnant or breast feeding at the time of restoration placement
* Intolerance or allergy toward the applied restorative materials

Primary outcomes:
measure: Clinical success of the restoration
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Mohamed S Ellithy, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Rania R Afifi, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Mohamed H Hussein, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00628368: Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
Official title: Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Esophageal Cancer
Keywords: adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
adenocarcinoma of the rectum
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

Detailed description: OBJECTIVES:

Primary

* Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.

Secondary

* Establish a tissue bank to store information about the response to treatment and survival.

OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.

After surgery, patients are followed every 3 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum
* Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No blood disorder
* Not deprived of freedom or protected by law

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Role of predictive factors in the EGFR signaling pathway in response to treatment
Secondary outcomes:
measure: Establishment of a tissue bank
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Marc Ychou, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04316468: Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation
Official title: Evaluation of Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Transplant Disorder
Reperfusion Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 20
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: Sequential liver transplant candidates (adults) will be approached for consent to participate in the study at the time of liver transplantation by a member of the liver anesthesia team.

Brief summary: Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Undergoing primary orthotopic liver transplantation

Exclusion Criteria:

* Redo orthotopic transplantation
* Acute or fulminant liver failure
* Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
* Patients with an abnormal preoperative stress test (EF \<55%, areas of prior infarct, ongoing ischemia)

Primary outcomes:
measure: Degree of change in cardiac strain
timeFrame: Up to 1 hour after graft reperfusion
Secondary outcomes:
measure: Pattern of right and left ventricular strain
timeFrame: Up to 5 hours from the time of surgery start
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Stephen Aniskevich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03832868: Syngery-Evaluating the Impact of Decision Aid
Official title: Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Cardioverter-defibrillators (ICDs)
Keywords: Decision aid
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each "arm." No blinding will occur.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Detailed description: There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)

Primary outcomes:
measure: Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
timeFrame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Secondary outcomes:
measure: Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants
timeFrame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
measure: Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants
timeFrame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Faisal Merchant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03635268: Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
Official title: Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravitreal Injection
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 360000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has had an intravitreal injection to deliver an anti-angiogenic agent or a corticosteroid

Brief summary: Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.

Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.

Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.

The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.


Eligibility criteria: Inclusion Criteria:

* adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
* associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
* between February 2007 and November 2015

Exclusion Criteria:

* intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
* risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code

Primary outcomes:
measure: Frequency of occurrence of endophthalmitis
timeFrame: Up to 28 days following an intravitreal injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: