louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01771172: Acute Subcutaneous Defibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrhythmias
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study

Brief summary: To assess the defibrillation efficacy of a subcutaneous defibrillation system.


Eligibility criteria: Inclusion Criteria:

* Subject must be undergoing implant of a commercially approved ICD system
* Subject must be willing to provide Informed Consent
* Subject must be \> 18 years old

Exclusion Criteria:

* Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate \< 29 mls/min/1.73m2 (recorded in the last six months)
* Subject has high risk of infection
* Subject has EF \< 15%
* Subject at high risk of stroke
* having a device replacement
* Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
* Subject is indicated for CRT
* Subject is pacemaker dependent
* Subject enrolled in a concurrent study that may confound the results of this study
* Subject has medical conditions that would limit study participation
* Subject is pregnant
* Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)

Primary outcomes:
measure: Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
timeFrame: within the first day
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Center Cardiology
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bratislava
country: Slovakia
facility: Slovak Medical University
city: Dudley
country: United Kingdom
facility: Dudley Group NHS-Russells Hall Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Southhampton
country: United Kingdom
facility: Southhampton General Hospital
Study officials:
References:
Clinical trial NCT01472172: Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Official title: Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pleural Effusion
Pleural Diseases
Keywords: Flex-rigid pleuroscopy
cryobiopsy
pleural biopsy
pleural effusion
safety
thoracoscopy
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

Detailed description: The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Eligibility criteria: Inclusion Criteria:

* 18 or more years old
* Unilateral pleural effusion of unknown origin
* Pleural irregularities suspicious for pleural malignancy
* Referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

* Uncontrolled bleeding tendency
* Unstable cardiovascular status
* Severe heart failure
* ECOG performance status 4
* Persistent hypoxemia after evacuation of pleural fluid
* Pleural symphisis, fibrothorax

Primary outcomes:
measure: Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
timeFrame: 12 months
measure: Size of biopsy samples
timeFrame: 12 months
measure: Quality of the sample
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding
timeFrame: 1 month
Other outcomes:
Locations:
city: Golnik 36
country: Slovenia
facility: University Clinic Golnik
state: Golnik
Study officials:
affiliation: University Clinic Golnik
name: Ales Rozman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069172: Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery
Official title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract
Surgery, cataract extraction
Optical devices, laser
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.


Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with the treatment/follow-up schedule and requirements
* Able to understand and provide written Informed Consent
* ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
* Age between 50 and 80 years old
* Pupil dilates to at least 7 mm
* Subject able to fixate
* Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III)
* Axial length between 22 and 26 mm

Exclusion Criteria:

* Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
* Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
* Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
* History of prior ocular surgery
* History of ocular trauma
* Co-existing ocular disease affecting vision
* History or current use of alpha-1 antagonist medication (e.g., Flomax)
* Known sensitivity to planned concomitant medications

Primary outcomes:
measure: Deviation From Intended Capsulotomy Diameter
timeFrame: Day of Surgery
Secondary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day of Surgery
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Laser Center
Study officials:
affiliation: Laser Center
name: Juan F Batlle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: William W Culberston, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01509872: Psychological and Psychosocial Intervention With War-Affected Children
Official title: An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Anxiety
Conduct
Pro-social Behavior
Keywords: Trauma-Focused Cognitive Behavior Therapy
War-affected Children
Post-traumatic Stress Symptoms
Psychosocial Distress
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Transcultural Psychosocial Organization Nepal
name: UNICEF
First posted: 2012-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.


Eligibility criteria: Inclusion Criteria:

* under 18 years of age,
* witness to a violent event involving a real or perceived direct threat to life,
* ability to attend a 3-week intervention

Exclusion Criteria:

* psychosis,
* mental retardation,
* inability to understand Swahili,
* severe emotional \& behavioral problems that made group participation impossible

Primary outcomes:
measure: Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
timeFrame: baseline, 3 week post-intervention and 6-month follow up
Secondary outcomes:
measure: Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
timeFrame: baseline, 3 week post-intervention and 6 month follow up
measure: Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument
timeFrame: baseline, 3-week post-intervention, 6-month follow up
measure: Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument
timeFrame: baseline, 3-week post-intervention, 6-month follow up
Other outcomes:
Locations:
city: Mwenga
country: Congo
facility: Child Friendly Space
state: South Kivu
Study officials:
affiliation: British Psychological Society (Chartered Clinical Psychologist)
name: Dr Ciarán Shannon, BA, MA, DClin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02846272: Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation
Official title: Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intractable Epilepsy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.

Detailed description: To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. All enrolled children will undergo standard preoperative and postoperative MRI imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. This imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. This study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.

Eligibility criteria: Inclusion Criteria:

* Children diagnosis with Intractable Epilepsy

Exclusion Criteria:

* No Intractable Epilepsy

Primary outcomes:
measure: Number of participants with seizure outcome as determined by Engel
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHealth & Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: UTHealth Medical School
name: Manish N Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317472: The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
Official title: A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laryngopharyngeal Reflux
Keywords: laryngopharyngeal reflux, acid reflux, throat reflux
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.

Detailed description: The aim of the study is to compare outcomes, based on RSI-based symptomatic improvement and pharyngeal probe results, after LPR patients are treated for two months with once-daily (QAM) Kapidex versus placebo.Forty patients with pharyngeal pH probe-documented LPR and an elevated reflux symptom index (RSI) (≥14) will be enrolled into a double-blinded placebo controlled study. Twenty patients will receive Kapidex once daily, while twenty receive placebo. Patients will return at two months for evaluation with repeat RSI documentation and repeat pharyngeal pH probe testing. Student t-test will be used to determine if the change in RSI and pH-probe results differs between the study and placebo group.

Eligibility criteria: Inclusion Criteria:patients with an abnormal Restech pH probe study and also have an RSI of 14 or greater will be invited to participate in the study

Exclusion Criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (Zollinger-Ellison), self-reported anxiety/depression (shown to affect RSI),16 history of laryngeal irradiation, or have been on twice daily Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)

Primary outcomes:
measure: Change in Reflux Symptom Index (RSI)
timeFrame: Baseline to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian North Hospital -- IUMG Clinic
state: Indiana
Study officials:
affiliation: Indiana University
name: Stacey L Halum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120572: Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer
Official title: Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Local Esophagus Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Respiratory muscle strength
Diaphragmatic surface electromyography
Functional capacity
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly diagnosed primary esophageal cancer

Brief summary: The purpose of this study is to investigate the effect of concurrent chemoradiation therapy on respiratory muscle performance, lung function and functional capacity in patients with local esophagus cancer.

Detailed description: This is a prospective observational study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test).Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed primary esophageal cancer, aged more than 20 years, and communicate without difficulty

Exclusion Criteria:

* inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy

Primary outcomes:
measure: Change of maximal inspiratory pressure (MIP)
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
measure: Change of diaphragmatic surface electromyography (EMGdi)
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
measure: Change of forced expiratory volume in one second (FEV1)
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
measure: Change of forced vital capacity (FVC)
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Secondary outcomes:
measure: Change of functional exercise capacity
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
measure: Change of dyspnea
timeFrame: Baseline, weekly during treatment, and 2 weeks after the completion of treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
Clinical trial NCT01057472: Repeatability and Feasibility of Infant Spirometry
Official title: Repeatability and Feasibility of Infant Spirometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Keywords: Repeatability of measurements
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term born and preterm born babies

Brief summary: This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.


Eligibility criteria: Inclusion Criteria:

* Being a Term born and preterm born babies

Exclusion Criteria:

* Being in an unstable clinical condition

Primary outcomes:
measure: Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams
timeFrame: Before and after a meal
Secondary outcomes:
measure: Feasibility of the measurements in the NICU
timeFrame: 1 year
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Pediatric Department, NICU
Study officials:
affiliation: Haukeland University Hospital
name: Thomas Halvorsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219972: Pulmonary Complications of Allografts
Official title: Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Complications
Keywords: Bone marrow transplant
Pulmonary complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 245
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: Patients who underwent a allogeneic blood stem cell transplantation, alive at 100 days post-transplantation

Brief summary: This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

Detailed description: * Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation
* Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.
* Sample Size 200 transplanted patients
* Main Endpoint Non infectious pulmonary complications within the first 3 years

Eligibility criteria: Inclusion Criteria:

* Allogeneic Blood stem cell transplantation
* Alive at day 100 post-transplant

Exclusion Criteria:

* Non informed consent

Primary outcomes:
measure: Non infectious pulmonary complication
timeFrame: 3 years
Secondary outcomes:
measure: Survival after non infectious pulmonary complication
timeFrame: 3 years and 10 years
measure: Overall survival
timeFrame: 3 years and 10 years
measure: Long term time course of Pulmonary Function Tests (PFTs)
timeFrame: 3 years and 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne Bergeron - Laffaurie,, PhDMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergeron A, Chevret S, Peffault de Latour R, Chagnon K, de Margerie-Mellon C, Riviere F, Robin M, Mani J, Lorillon G, Socie G, Tazi A. Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation. Eur Respir J. 2018 May 3;51(5):1702617. doi: 10.1183/13993003.02617-2017. Print 2018 May.