louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02771223: Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation
Official title: Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation for Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulopathy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-05-13
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: adults over 18 yo scheduled for prolonged cardiac surgery requiring ECC time over 3 hours,

Brief summary: Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy

Detailed description: Quantification of the effect of ECC duration on blood coagulation and platelet number and function

* Observational study on 20 patients undergoing prolonged ECC
* Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies
* Blood test to be performed in Rambam Blood Bank Laboratory

Eligibility criteria: Inclusion Criteria:

* adults over 18 yo
* scheduled for prolonged cardiac surgery requiring ECC time over 3 hours

Exclusion Criteria:

* documented coagulopathy
* antiplatelet therapy other then aspirin

Primary outcomes:
measure: Change in Platelet function apoptosis markers
timeFrame: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
measure: Change in Platelet function activation markers
timeFrame: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
Secondary outcomes:
measure: Change in platelet count over time
timeFrame: Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02893423: Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia
Official title: The Dose Dependent Effect of Ropivacaine Transversus Abdominis Plane Blocks on Postoperative Analgesia After Cesarean Section
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Keywords: Ropivacaine
C-Section Analgesia
Tap Block
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section).

Detailed description: With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section). The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. The investigators will inject the local anesthetic ropivacaine into this space to freeze these nerves and prevent pain following c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%, 0%) to determine the lowest dose that controls pain with the fewest side effects. Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3) ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain with cough will be collected along with the time to first postoperative analgesic request, patient satisfaction scores, and patient demographics. The analgesic regimen will be considered effective if it provides lower average visual analog scores for pain with movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer postoperative analgesic requests, and fewer side effects.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients undergoing elective c-section

Exclusion criteria:

* Allergy to local anesthetics
* Contraindication to tap blocks

Primary outcomes:
measure: POSTOPERATIVE PAIN
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219
name: KALPANA TYAGARAJ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02650323: Observational Registry on Acute Coronary Syndromes in Campania
Official title: Registro Campano Delle Sindromi Coronariche Acute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patints hospitalized for Acute Coronary Syndromes

Brief summary: This registry aims to collect data related to management of patients affected by acute coronary syndromes and hospitalized in the Campania Region of Italy


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for acute coronary syndromes

Exclusion Criteria:

* Refuse to provide informed consent for study enrollment

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Ambulatorio Ipertensione e Unità Coronarica Federico II University
Study officials:
affiliation: University of Napoli Federico II
name: Bruno Trimarco, MD
role: STUDY_CHAIR
affiliation: Federico II University
name: RAFFAELE IZZO
role: STUDY_DIRECTOR
References:
Clinical trial NCT01290523: Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma
Official title: Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
* The cancer is unresectable.
* All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Age 18 years or older.
* Able to understand informed consent.

Exclusion Criteria:

* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  * single TheraSphere administration; or
  * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
* Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
* Previous radiation therapy to the lungs and/or to the upper abdomen
* Pregnancy
* Symptomatic lung disease.
* Significant extrahepatic disease representing an imminent life-threatening outcome.
* Active uncontrolled infection
* Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

  * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
  * Serum bilirubin greater than 2 mg/dl
  * Infiltrative tumor on imaging
  * Tumor volume greater than 70% of liver volume
  * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nicholas Fidelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03143023: Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid
Official title: Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.

Detailed description: .28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.

Eligibility criteria: Inclusion Criteria:

* Participants should be over 18 years of age.
* Systematically healthy.
* Not taking any medication interfering with saliva secretion.
* Participants who signed informed consent.

Exclusion Criteria:

* Participants with a compromised medical history.
* Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
* Severe or active periodontal disease.
* History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.

Primary outcomes:
measure: salivary pH
timeFrame: 10 minutes after intervention and control
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02220023: Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
Official title: Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pulmonary Vascular Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2014-08-19
Enrollment: 17
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 the study is to measure RV ejection fraction (RVEF), pulmonary flow, and pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on invasive catheterization as well as healthy subjects. Measurements will also be made after high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to measure dynamic changes in RV-pulmonary vascular function in patients with vasodilator-responsive PAH.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 or older of the Vanderbilt Center for Pulmonary Vascular Disease. Vasodilator-responsive patients will be identified based on prior response to inhaled nitric oxide during invasive right heart catheterization
* Healthy subjects age 18 or older not known to have cardiopulmonary disease

Exclusion Criteria:

* Standard conventional contraindications for cardiac magnetic resonance (CMR) imaging
* Allergy or contraindication to Magnevist (gadopentetate dimeglumine) contrast
* Concurrent intravenous epoprostenol infusion in whom performance of CMR is cumbersome
* Pregnant women

Primary outcomes:
measure: Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure
timeFrame: At time of procedure
Secondary outcomes:
measure: Pulmonary flow
timeFrame: Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
measure: Pulmonary perfusion
timeFrame: Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
measure: Estimates of pulmonary vascular resistance
timeFrame: At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide
measure: Pulmonary transit time
timeFrame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
measure: Pulmonary artery compliance
timeFrame: At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Evan L Brittain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00840723: Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects
Official title: Bronchoscopy-Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Diseases
Keywords: Healthy smokers
Current cigarette smokers
No lung disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current cigarette smokers who are otherwise healthy (no lung disease or other chronic illness and healthy controls

Brief summary: The purpose of this research study is to collect cells and liquid from the air passages of healthy adults, both smokers and non-smokers. These samples will be used for test-tube studies to explore mechanisms of diseases of the respiratory tract, and to compare the samples between people who smoke cigarettes and people who don't. Obtaining these samples requires an invasive procedure called "bronchoscopy".


Eligibility criteria: Inclusion Criteria:

* Current cigarette smokers
* Must be otherwise healthy with no chronic illness

Exclusion Criteria:

* Asthma
* Smoking related lung disease (including bronchitis)

Primary outcomes:
measure: The goal of this project is to define the effect of smoking on key aspects of airway biology. These studies will also provide crucial & novel definition of airway biology in smokers against which COPD & CF patients will be compared.
timeFrame: At the time of bronchoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Raymond Coakley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888823: Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer
Official title: Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Fractionated stereotactic radiotherapy
Medically inoperable
Image-guided radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2009-04-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

Detailed description: OBJECTIVES:

Primary Objectives

* To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year.
* To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

Eligibility criteria: Inclusion Criteria:

* T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only)
* Medically inoperable due to co-morbid conditions or patient preference for radiation
* adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist
* age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70

Exclusion Criteria:

* Presence of mediastinal metastases or distant metastases
* Life expectancy less than 1 year due to other co-morbid conditions

Primary outcomes:
measure: Local Control
timeFrame: One Year
Secondary outcomes:
measure: Toxicity
timeFrame: One Year
measure: Quality of Life
timeFrame: One Year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References:
Clinical trial NCT05353023: Intensive Care Unit Activity in France From the National Database Between 2013 and 2019
Official title: Intensive Care Unit Activity in France From the National Database Between 2013 and 2019: More Critically Ill Patients, Shorter Stay and Lower Mortality Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 1594801
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: All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019

Brief summary: Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):

* In-ICU and in-hospital mortality rates
* Length of stay in ICU and hospital
* Mortality-associated factors during the study period.
* Number of organ failures
* Bed occupancy,
* Regional variations in previous indicators


Eligibility criteria: Inclusion Criteria:

All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019

Primary outcomes:
measure: Evolution in mortality rate
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Evolution in organ failure rate
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Evolution in ICU stay
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Evolution in SAPS (Simplified Acute Physiology Score) II score at admission
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Evolution in age at admission
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Evolution in sex ratio
timeFrame: from January 1st, 2013, to December 31st, 2019
Secondary outcomes:
measure: Proportion of patients admitted in ICU with at least 2 different organ failures
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: - Proportion of patients admitted in ICU with a SAPS II score over 15 and with a specific ICU supportive therapy
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Factors Associated with in-ICU mortality
timeFrame: from January 1st, 2013, to December 31st, 2019
measure: Regional variations
timeFrame: from January 1st, 2013, to December 31st, 2019
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Intensive care Unit CHU Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jean Yves LEFRANT
role: PRINCIPAL_INVESTIGATOR
References: