louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06604884: NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Official title: Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Vantage Embolization Device with Shield Technology™ device are eligible for the registry

Brief summary: The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

Detailed description: The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™.

This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).

Eligibility criteria: Inclusion Criteria:

1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.
2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
3. Patient is an adult per local law at time of consent.

Exclusion Criteria:

1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
2. Patient who may be unable to complete the study follow-up.
3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.

Primary outcomes:
measure: Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medtronic
name: Harsh Sancheti
role: STUDY_DIRECTOR
References:
Clinical trial NCT02032784: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Official title: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Adenoma
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.

Detailed description: Inclusion Criteria:

Duodenal or ampullary adenoma greater than or equal to 10mm. Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection.

Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female

Exclusion criteria:

Duodenal or ampullary adenoma \<10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide Informed Consent Less than 18 years old Allergy to Octreotide

Eligibility criteria: Inclusion Criteria:

Duodenal or ampullary adenoma greater than or equal to 10mm Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female

Exclusion Criteria:

Duodenal or ampullary adenoma \<10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide informed consent Less than 18 years old Allergy to Octreotide

Primary outcomes:
measure: Post endoscopic mucosal resection bleeding
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Robert Hawes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695084: Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)
Official title: Constraint-Induced Movement Therapy Trial for Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
Lead sponsor: National Multiple Sclerosis Society
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy.

Detailed description: Constraint-Induced Movement Therapy was developed to treat stroke hemiparesis. Due to the similarity between multiple sclerosis and stroke in terms of chronic motor deficit, this trial will attempt to determine whether multiple sclerosis may benefit similarly from Constraint-Induced Movement Therapy.

Eligibility criteria: Inclusion Criteria:

* Chronic upper extremity motor deficit due to multiple sclerosis

Exclusion Criteria:

* Relapse within 3 months of planned enrollment.

Primary outcomes:
measure: Improvement on the Motor Activity Log
timeFrame: One year
Secondary outcomes:
measure: Improvement on the Wolf Motor Function Test
timeFrame: Pre to post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Victor W Mark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844584: Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope
Official title: Clinical Study of Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
radiofrequency
totally thoracoscope
epicardial
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The fact that pharmacological therapy of AF is at best 50% effective has led to a search for surgical approaches over the last 20 years.

Maze procedure was a classic method to treat AF. However, it is such a complex procedure that very few surgeons have adopted it. A few minimally invasive procedures to create transmural lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is catheter-based radiofrequency ablation, another one is video assisted epicardial radiofrequency ablation through small thoracic incisions in operating room.

Recently, we invented an epicardial radiofrequency ablation method under totally thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.


Eligibility criteria: Inclusion Criteria:

* Any patients with atrial fibrillation

Exclusion Criteria:

* Patients with hemostasis defects
* patients can not endure general anesthesia

Primary outcomes:
measure: Electrocardiography
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Institute of Cardiovascular Surgery, Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Dinghua Yi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03101384: Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
Official title: Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Pulmonary Embolism and Thrombosis
Diagnostic Errors
Embolism
Pulmonary Vascular Disorder
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an episode of first acute symptomatic pulmonary embolism

Brief summary: Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Episode of symptomatic acute pulmonary embolism objectively proven

Exclusion Criteria:

* Below 18 years of age
* Patient chronically receiving therapeutic anticoagulation
* Pulmonary embolism complicating a current hospitalisation for another medical reason
* Asymptomatic pulmonary embolism

Primary outcomes:
measure: Severity of pulmonary embolism at the time of diagnosis
timeFrame: Day 1
Secondary outcomes:
measure: Complication of pulmonary embolism
timeFrame: Day 30 and 180
measure: Frequency of diagnostic errors
timeFrame: Day 1
measure: Characteristic of patient with diagnosis errors
timeFrame: Day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
state: Ile de France
Study officials:
affiliation: Hôpital Européen Georges Pompidou, AP-HP
name: Guy Meyer, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647084: Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
Official title: Pilot Randomized Control Trial: Comparing the Effectiveness of Buzzy Versus Intradermal Lidocaine for Peripheral Intravenous Cannulation in Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Acute
Patient Satisfaction
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: IV placement is necessary for surgical procedures. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable.

Detailed description: Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers inject a numbing medication underneath the skin prior to the IV placement. This requires an additional needle stick. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients.

The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of the injection of numbing medication underneath the skin for IV placement in adults. This device has been FDA approved for use.

Eligibility criteria: Inclusion Criteria:

1. Adults ages 18 to 99
2. Non-pregnant women and men
3. Adults that are able to consent
4. Patients requiring intravenous catheter insertion for their operation/procedure

Exclusion Criteria:

-

Primary outcomes:
measure: Pain with IV Cannulation based on the Visual Analog Scale
timeFrame: 5-20 minutes
Secondary outcomes:
measure: Satisfaction with IV cannulation based on the Numerical Rating Scale
timeFrame: 5-20 minutes
measure: Number of IV cannulation attempts
timeFrame: 5-20 minutes
measure: Pain related to IV size based on the Visual Analog Scale
timeFrame: 5-20 minutes
measure: Pain related to IV location based on the Visual Analog Scale
timeFrame: 5-20 minutes
Other outcomes:
Locations:
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: physician
name: Michael Schoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02699684: Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
Official title: One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

Detailed description: Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

Eligibility criteria: Inclusion Criteria:

* Must sign Informed Consent Document;
* Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
* Willing to answer text messages on a daily basis during the study;
* Willing to discontinue artificial tears and rewetting drops on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Pregnant or lactating;
* Participation in any clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
timeFrame: Day 30, each product
Secondary outcomes:
measure: Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
timeFrame: Day 30, each product
measure: Change From Insertion in Minimum Protected Area (MPA)
timeFrame: Hour 0 (Lens Insertion) to Hour 12 on Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Trial Manager, EMEA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00888784: Secondary Prophylaxis Gastric Variceal Bleed
Official title: Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2009-04-28
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.


Eligibility criteria: Inclusion Criteria:

* Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included

Exclusion Criteria:

* Presence of esophageal varix
* GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
* Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV
* Patients already on beta-blocker or nitrates
* Undetermined origin of bleeding from esophageal varix or gastric varix
* Hepatic encephalopathy grade III/IV
* Hepatorenal syndrome
* Hepatocellular carcinoma
* Presence of deep jaundice (serum bilirubin \> 10 mg/dl)
* Uremia
* Cerebrovascular accident
* Cardiorespiratory failure
* Pregnancy or patients not giving informed consent for endoscopic procedures

Primary outcomes:
measure: Rebleeding from GV or death
timeFrame: Overall Study
Secondary outcomes:
measure: Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.
timeFrame: Overall Study
Other outcomes:
Locations:
city: New Delhi
country: India
facility: G B Pant Hospital
state: Delhi
Study officials:
affiliation: Director, G B Pant Hospital
name: Shiv K Sarin, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039.
Clinical trial NCT01315184: Study of Computer-Based Treatment for Drug Dependence
Official title: Pilot Trial of a Therapeutic Interactive Voice Response System for Buprenorphine Maintenance: The Recovery Line Support System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Heroin Dependence
Keywords: Interactive Voice Response
Computer-based Treatment
Opioid Agonist
Buprenorphine
Methadone
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-03-15
Enrollment: 36
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 purpose of this study is to evaluate the whether an automated telephone-based system is useful and helpful for opioid dependent patients receiving buprenorphine in primary care. The Recovery Line support system is a Therapeutic Interactive Voice Response system based on cognitive behavioral therapy (CBT). The Recovery Line support system includes a variety of modules presenting the basic principles and strategies of CBT. Each module includes learning sections and activities sections to provide direct guidance in using skills. The Recovery Line support system is interactive and also includes a questionnaire to help patients identify problems and recommend modules for use, as well as an inspiration section, an introduction, and an immediate assistance menu. Following development of an initial system the current trial will recruit 40 patients receiving buprenorphine maintenance from a physician provider in the local community. Patients will be randomly (flip of a coin) to receive the Recover Line Support system or to treatment as usual with their physician. Patients assigned to TIVR will be trained on the system and provided 24-hr access to the TIVR system for a four week period. Primary outcome variables will be how long patients remain in treatment, self-reported abstinence from opioids and other drugs, and abstinence as measured by weekly drug screens. It is expected that patients assigned to TIVR will better treatment outcomes than patients assigned to TAU.


Eligibility criteria: Inclusion Criteria:

* are at least 18 years old
* have initiated buprenorphine maintenance treatment from an approved physician in the previous two weeks

Exclusion Criteria:

* are a current suicide or homicide risk or meet criteria for psychiatric disorder that would interfere with ability to complete study
* are unable to read or understand English
* have a life-threatening or unstable medical problem

Primary outcomes:
measure: Opioid Abstinence
timeFrame: 4 Weeks
measure: Retention
timeFrame: 4 Weeks
Secondary outcomes:
measure: Self Reported Drug Abstinent
timeFrame: 4 weeks
measure: system use
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Brent A. Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: