louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569686: Lovaza Therapy of Peripheral Arterial Disease
Official title: Lovaza Therapy of Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: PAD
peripheral artery disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Reliant Pharmaceuticals
First posted: 2007-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (\>200 mg/dl) already treated with statins will be imaged at baseline and randomized to Lovaza and placebo for 12 months. MR imaging will be repeated at the end of the 12-month period.

We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year compared to placebo. Secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance with Lovaza compared to matching placebo.


Eligibility criteria: Inclusion Criteria:

* Male or female, any ethnicity, ages 55-75
* Mild to moderate PAD (ankle brachial index (ABI) of 0.4-0.9 in either or both limbs)
* Symptomatic intermittent claudication in either or both limbs
* Hyperlipidemia treated with HMG-CoA reductase inhibition with persistent hypertriglyceridemia (triglycerides\>200).

Exclusion Criteria:

* Patients with critical limb ischemia
* Moderate to severe chronic kidney disease (requiring hemodialysis or glomerular filtration rate (GFR) \< 45 ml/min)
* Contraindication to MRI (pacemakers, defibrillators, intraocular metal, certain intracerebral aneurysm clips, etc.)
* Claustrophobia
* Known allergy to gadolinium chelates
* Patients with iron storage disease

Primary outcomes:
measure: treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce or prevent progression of atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year as compared to placebo.
timeFrame: one year
Secondary outcomes:
measure: show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved
timeFrame: 1 year
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Christopher Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04411186: A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
Official title: A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Hepatobiliary Surgery
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 100
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: The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.


Eligibility criteria: Inclusion Criteria:

* All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART hospital who would normally be utilizing the existing ERAS protocols
* English speaking
* Able to give informed consent
* Ages 18 years and older

Exclusion Criteria:

* Emergency cases
* Pregnant subjects-confirmed by pre-operative urine pregnancy test
* Subjects with unique lung pathologies including, but not limited to: advanced pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary Hypertension
* Subjects on home O2

Primary outcomes:
measure: Inspiratory Capacity
timeFrame: 2 hours
Secondary outcomes:
measure: Oxygen Saturation (SPO2) Trends
timeFrame: 2 hours
measure: Incidence of Supplemental Oxygen Requirements
timeFrame: 2 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: David Gutman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02285686: Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
Official title: Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Troponin
Critical Care
Myocardial Infarction
Keywords: troponin
biomarkers
myocardial infarction
critical illness
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 251
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: Critically ill patients

Brief summary: Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management.

This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.


Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.

Exclusion Criteria:

* Patients who are admitted and die or are discharged within 12 hours
* Patients re-admitted to ICU during the index ICU enrolment month

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 month
measure: Data collection time per patient
timeFrame: 3 months
measure: rate of successful deferred informed consent definition
timeFrame: 1 month
Secondary outcomes:
measure: All-cause in-hospital mortality
timeFrame: 3 months
measure: Troponin elevations
timeFrame: 3 months
measure: Myocardial infarction
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05196386: Usual Care Intervention Research Evaluating the Impact of a Personalized Pharmaceutical Plan on the Duration of Opioid Treatment in Non-cancerous Pain
Official title: Usual Care Intervention Research Evaluating the Impact of a Personalized Pharmaceutical Plan on the Duration of Opioid Treatment in Non-cancerous Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-cancerous Pain
Opioid Use
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many treatments with WHO grade III opioids are being introduced in the rheumatology department for non-cancerous pain. The duration of this treatment prescribed at discharge is often uncontrolled and sometimes leads to significant addiction.

The team at the local pain center recommends an average duration of 28 days for this type of pain. There is a full-time pharmacy intern in the rheumatology department.

The aim of this work is to evaluate the impact of a targeted pharmaceutical interview on the duration of the morphine treatment initiated during hospitalization.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and \< 75 years old when entering the rheumatology department
* Hospitalization in the rheumatology department
* Patient with acute non-traumatic musculoskeletal disease
* Patient not taking grade III opioid treatment
* Patient affiliated to a social security scheme
* Patient having read and understood the information letter and signed the consent form
* Patient present on a day which the pharmacy intern is present

Exclusion Criteria:

* Presence of cancer, fibromyalgia, already diagnosed at inclusion
* Patient does not understand French
* Patient with Current or past opioid addiction
* Person deprived of liberty by administrative or judicial decision

Primary outcomes:
measure: Total duration of opioid treatment
timeFrame: 6 months
Secondary outcomes:
measure: Rate of patients exceeding 28 days of cumulative duration of treatment
timeFrame: 6 months
measure: Rate of patients exceeding 90 days of cumulative duration of treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Olivier VITTECOQ, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Remi VARIN, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Catherine CHENAILLER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04604886: The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
Official title: The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Cardiac Output
Keywords: Hemodynamic Monitoring
Pulmonary artery catherization
LiDCO
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 1. To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients
2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Detailed description: Close monitoring of cardiac output (CO), especially in patients before and after intervention(such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), could help to adjust the treatment strategy in cardiac surgical patients. Pulmonary artery catherization (PAC) has been used for hemodynamic monitoring for more than four decades. In spite of its invasiveness, it remains the clinical reference method for the assessment of CO at the bedside. Nowadays, many less invasive alternatives, such as LiDCO Rapid Pulse Contour Analysis System (LiDCO Ltd., Cambridge, United Kingdom), are already available on market. However, consistency between different hemodynamic monitoring results still raise concern. And whether hemodynamic monitoring could accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. In this study, the investigators are going to collect CO and changes of CO from PAC and LiDCO before and after intervention (passive leg raising and dobutamine stress test) in cardiac surgical patients. Our resulst could provide important reference for cardiac surgical patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Eligibility criteria: Inclusion Criteria:

1. cardiac surgery
2. hemodynamic monitoring (PAC, LiDCO)
3. mechanical ventilation

Exclusion Criteria:

1. cardiac arrhythmia
2. moderate to severe aortic, mitral and tricuspid regurgitation
3. IABP
4. ECMO

Primary outcomes:
measure: Baseline Cardiac Output measurement
timeFrame: within1 minute at baseline position
measure: Cardiac Output measurement after PLR
timeFrame: 1 minute after PLR
measure: Cardiac Output measurement after Dobutamine stress test
timeFrame: 5 minutes after dobutamine stress test
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University
name: Zhe Luo, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00574886: Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With Failed Induction Chemotherapy
Official title: Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Genitope Corporation
First posted: 2007-12-17
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging.

Detailed description: This trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on trials 0197-99-FB and 0196-99-FB. These follicular NHL participants then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants are then followed annually until progression or death with standard staging. Immune response testing continues annually on participants who continue to have a response post transplant.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma
* original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine
* failed to achieve PR or CR with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a CR or good PR following transplantation

  -\>/= 19 years
* signed informed consent
* non-pregnant, non-lactating

Exclusion Criteria:

* serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

Primary outcomes:
measure: Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant
timeFrame: After vaccination
Secondary outcomes:
measure: Safety and toxicity of idiotype vaccine post-transplant setting
timeFrame: Post-transplant vaccination
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Julie Vose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498586: Half-normal Saline in Atrial Fibrillation Ablation
Official title: Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.


Eligibility criteria: Inclusion criteria

* male or female between 18 and 75 years of age at the time of enrollment
* undergoing first-time radiofrequency ablation for atrial fibrillation
* written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

* robotic-guided atrial fibrillation ablation
* baseline hyponatremia (serum sodium level \< 135 mEq/L)
* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Primary outcomes:
measure: total radiofrequency ablation time, and total procedure time
timeFrame: intraprocedural
measure: acute pulmonary veins, and left atrial appendage (if applicable) reconnection
timeFrame: intraprocedural
measure: freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
timeFrame: 1 year
Secondary outcomes:
measure: freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs
timeFrame: 1 year
measure: long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection
timeFrame: in case of a repeat procedure performed during the study follow-up (an average of 1 year)
Other outcomes:
measure: procedure-related complications
timeFrame: periprocedural (at the time of the procedure and up to 1 month)
measure: hyponatremia
timeFrame: periprocedural (at the time of the procedure and up to 1 month)
Locations:
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute, St. David's Medical Center
state: Texas
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655486: Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Official title: A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsies
Partial Onset Seizures
Keywords: Epilepsy
seizures
antiepileptic
Lacosamide
Vimpat
safety
adjunctive
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 97
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

Detailed description: A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Eligibility criteria: Inclusion Criteria:

* Eligible subjects who participated in SP925 \[NCT00655551\] for treatment of partial-onset seizures

Exclusion Criteria:

* Receiving any study drug or experimental device other than lacosamide
* Meets withdrawal criteria for parent study SP925 \[NCT00655551\]
* Experiencing ongoing serious adverse event

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
timeFrame: 2 years
measure: Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Baltimore
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Missouri
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: