louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02979652: Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?
Official title: Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care, Surgical
Lead sponsor: Hospital Nord
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 325
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: patients hospatilized for a major surgery

Brief summary: This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk


Eligibility criteria: Inclusion Criteria:

* Physical status score \> 1
* Anesthesia of duration \> 1 hour
* Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery

Exclusion Criteria:

* Technical incapacity of accessibility to the ultrasound window
* Cardiac or pulmonary transplant

Primary outcomes:
measure: cardiac and pulmonary functions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Departement anesthesie reanimation hopital nord
Study officials:
affiliation: Departement anesthesie reanimation hopital nord
name: Marc Leone, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01010152: Comparative Bioavailability Study of Codeine Sulfate
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CEDRA Clinical Research LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick Bieberdorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03417752: The Use of Public Messaging for the Promotion of Firearm Safety to Veterans
Official title: Unlocking the Potential of VA Means Safety Programs: An Examination of the Use of Public Messaging for the Promotion of Firearm Safety to Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2018-01-31
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot study seeks to determine if exposure to the firearm safety public service announcement (PSA) developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in related beliefs and safe storage practices. Participants are randomly assigned to message exposure or control conditions. Data from this project will inform injury prevention outreach efforts targeted towards Veteran populations.


Eligibility criteria: Inclusion Criteria:

* Veterans of all gender/sex, race/ethnicities
* Living in United States
* Fluent in English language
* Capable of understanding the goals of the study
* Possess computer/internet access

Exclusion Criteria:

* Not a U.S. Veteran living in the United States
* Determined to be cognitively impaired
* Currently institutionalized (e.g., hospitalized; incarcerated, etc.)
* Do not possess computer/internet access

Primary outcomes:
measure: Number of Participants With Self-reported Injury Prevention Belief
timeFrame: baseline
measure: Number of Participants With Self-reported Injury Prevention Belief
timeFrame: 3 weeks post-baseline
Secondary outcomes:
measure: Number of Participants Who Self-reported Firearm Storage Behavior at Baseline
timeFrame: baseline
measure: Number of Participants Who Self-reported Firearm Storage Behavior at Exit
timeFrame: 3 weeks post-baseline
Other outcomes:
Locations:
Study officials:
affiliation: VA Center of Excellence for Suicide Prevention
name: Elizabeth Karras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02718352: A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence
Official title: A Naturalistic Study of Adolescents and Young Adults in Treatment for Opioid Dependence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty16 to 25 year old opioid treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program.

Brief summary: Many buprenorphine treatment programs do not have services dedicated to adolescents and young adults. As a precursor to developing and evaluating an adolescent and young adult buprenorphine treatment program at APT Foundation Inc, we propose to conduct a 1 year prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the APT Adolescent and Young Adult Suboxone Program

Detailed description: Participants will consent to in-person assessments and monthly chart reviews. We anticipate that the results from this study will inform the development of future services targeted towards adolescents and young adults with opioid dependence.

Eligibility criteria: Inclusion Criteria:

* Ages 16 through 25 at time of induction
* Meet criteria for enrollment in the APT Adolescent and Young Adult Suboxone Program (Opioid Dependence per DSM-V criteria; no contraindications to buprenorphine (concomitant benzodiazepine, alcohol use, sedative use),
* Stable enough to participate in outpatient care/intensive outpatient care for at least 12 weeks;
* Can commit to at least 12 weeks of treatment through the APT Adolescent and Young Adult Suboxone Program
* Are willing to provide locator information for follow-up.
* Are fluent in English and have a 6th grader or higher reading level

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder, or active suicidal ideation
* Are physically dependent on alcohol, benzodiazepines, or other sedatives.
* Are in custody of the Department of Children and Families

Primary outcomes:
measure: Opioid Use Patterns
timeFrame: baseline
measure: Opioid Use Patterns
timeFrame: 4 weeks
measure: Opioid Use Patterns
timeFrame: 8 weeks
measure: Opioid Use Patterns
timeFrame: 12 weeks
measure: Opioid Use Patterns
timeFrame: 24 weeks
measure: Opioid Use Patterns
timeFrame: 52 weeks
Secondary outcomes:
measure: Opioid Use Patterns
timeFrame: One year
measure: Cigarette Use Patterns
timeFrame: One year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepa Camenga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179152: Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic
Official title: Childhood Asthma and Return to School: the September Epidemic Exacerbation in Israel.A Controlled Trial of the Effectiveness of Preventive Treatment With Symbicort or Budicort Turbuhaler
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma Exacerbation
Keywords: asthma, september epidemic, children, preventive
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.

Detailed description: During the second week of September( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including Israel. A short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and ER visiting and hospitalization.

We will study the effectiveness of Budicort or Symbicort turbuhaler as a preventive treatment in children aged 6-18 years.

Eligibility criteria: Inclusion Criteria:

age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009

-

Exclusion Criteria:

any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ICS or montelukast from July 2010 Treated with oral steroids during the August 2010 asthma exacerbation one week prior study inclusion

Primary outcomes:
measure: reduction of asthma exacerbation during the study period
timeFrame: An average time of 8 weeks
Secondary outcomes:
measure: less primary care physician visits
timeFrame: An average time of 8 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Clalit Health Services
name: Avner He Cohen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston NJ, Johnston SL, Duncan JM, Greene JM,Keith PK,Roy M, Wsaerman S, Sears MR. The september epidemic of asthma exacerbation in children:a search for etiology. J allergy Clin Immunol 2005,115;132-8 Scheuerman O, Meyerowitch J, Marcus N, Hoffer V, Batt E , Garty B-Z. The september epidemic of asthma in Israel. J of Asthma 2009;46;652-5 Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM,Lambert K, Sears Mr. Attenuation of the september epidemic of asthma exacerbation in children: A randomized controlled trial of montelukast added to usual therapy. Pediatrics;120;e702-e712.
Clinical trial NCT01869452: Platform Therapeutic Education in Heart Failure and Coronary Disease
Official title: Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Acute Coronary Syndrome
Coronary Bypass Graft Stenosis of Native Artery Graft
Keywords: education
risk factors
quality of life
coronary disease
telephone follow up
dedicated nurse
Lead sponsor: Resicard
Sponsor class: OTHER
Collaborators: name: union nationale de formation et d'evaluation en medecine cardio-vasculaire
First posted: 2013-06-05
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.

Detailed description: Patients are assigned to an arm accordingly to their needs: class 1 with light therapeutic education, class 2 with moderate education, class 3 with heavy education. Assignement is based on the first education diagnosis during hospitalization time.

Quality of life and patient's knowledge are regularly evaluated through questionnaires

Eligibility criteria: Inclusion Criteria:

* hospitalization for acute coronary syndrome (ST-segment elevation myocardial infarction ,no ST-segment elevation myocardial infarction ST , unstable angina)
* hospitalization for heart failure
* acute coronary syndrome \< 3 months
* heart failure \< 3 months
* coronary by-pass surgery \< 3 months

Exclusion Criteria:

* complicated acute coronary syndrome (ventricular arrhythmia, heart failure, mechanical complications, cardiogenic shock)
* valvular cardiac pathology
* obstructive cardiomyopathy
* planned cardiac transplantation
* severe neurological or psychiatric troubles
* loss of autonomy
* other (refusal, language, nursing house, way of life not compatible with follow up, refusal of telephonic contacts)

Primary outcomes:
measure: number of patient with a better of quality of life
timeFrame: 1 year
Secondary outcomes:
measure: number of patients who improve their knowledge of disease
timeFrame: 1 year
measure: number of hospitalizations during the follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Coeur Effort Sante
city: Paris
country: France
facility: Clinique Turin
city: Paris
country: France
facility: Hopital Saint Antoine
city: Sarcelles
country: France
facility: Centre Cardiologique Alfred Kastler
Study officials:
affiliation: Resicard
name: ariel a cohen, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00748852: Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Official title: An Eight Week, Open-label Extension Study Evaluating the Safety of JTT-302 Administered Once Daily in Subjects With Low HDL-C Levels Who Have Completed the Treatment Phase of Study AT302-U-06-003
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.


Eligibility criteria: Inclusion Criteria:

* Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003

Exclusion Criteria:

* Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception
* Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol
* Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol
* Flu-shots not permitted during the study, including the follow-up period.

Primary outcomes:
measure: Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters
timeFrame: 4, 8 or 12 weeks
Other outcomes:
Locations:
city: Santa Ana
country: United States
state: California
Study officials:
References:
Clinical trial NCT01095432: Partial Wave Spectroscopic Detection of Colon Cancer Risk
Official title: Partial Wave Spectroscopic Detection of Colon Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Colon Cancer
Keywords: Colonoscopy
Flexible Sigmoidoscopy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2010-03-30
Enrollment: 40
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: Subjects who are scheduled to undergo a standard of care flexible sigmoidoscopy or a colonoscopy and have a history of UC.

Brief summary: The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).

Detailed description: The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.

Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years old or older.
* Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy.
* Patient has not received chemotherapy.
* History of ulcerative colitis.

Exclusion Criteria:

* Patient is unable to give informed consent..
* Patient has received chemo or radiation therapy within the past 3 months.

Primary outcomes:
measure: Study samples of rectal mucosa (the moist lining of the rectum) using PWS.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, DCAM
state: Illinois
Study officials:
affiliation: University of Chicago
name: David T Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03470532: Comparing Articaine and Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction
Official title: Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares the the efficacy of buccal infiltration of 4% Articaine and 2% Mepivacaine without any palatal injection during extraction of maxillary teeth. One group of patient receives buccal infiltration of Articaine and another group receives buccal infiltration of Mepivacaine.

Detailed description: Dense local anesthesia is required to reduce pain during extraction of tooth. Administration of local anesthesia to the palatal mucosa is proved to be the most painful due to its firm adherence to the underlying periosteum and also it's abundant nerve supply. Articaine has greater lipid solubility and high bone penetration property. Mepivacaine is proven to be the safest local anaesthetic agent. Avoidance of a palatal injection during extraction will benefit the patient by reducing pain and anxiety to a greater extent.

So this study compares the bone penetration property between Articaine and Mepivacaine by assessing the pain in the palatal mucosa while extracting the tooth using only buccal infiltration.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and above
* Patients requiring extraction of maxillary teeth which are grossly decayed, grade I mobile, root stumps or indicated for therapeutic extractions.
* Healthy patients ( ASA I ) or patients with mild systemic disease with no functional limitations (ASA II).
* Patients who are not allergic to the drugs used in the study

Exclusion Criteria:

* Patients with periapical infections.
* Patients who are on concurrent treatment with NSAIDs and corticosteroids

Primary outcomes:
measure: Measurement of pain intensity
timeFrame: 10 minutes after the administration of the drug
measure: Measurement of pain intensity
timeFrame: through the extraction procedure
measure: Measurement of pain intensity
timeFrame: Through the extraction procedure
Secondary outcomes:
measure: Response rate
timeFrame: Through the extraction procedure
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka Manipal Medical College
Study officials:
affiliation: Melaka Manipal Medical College,Faculty of Dentistry, Manipal Academy of Higher Education
name: Abdul k Azad, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03622632: Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Official title: Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Inflammation
Keywords: uric acid
organ failure
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2018-08-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple trauma patients admitted in the trauma center and requiring ICU admission.

Brief summary: The goal of this project, is to better understand the fluctuation of the level of uric acid in traumatized patients by making serial measurements during their hospitalization in the intensive care unit. In addition, the determinants (e.g. type of trauma, diseases, interventions) of the blood level of uric acid and its association with the development of organ failure will be sought.


Eligibility criteria: Inclusion Criteria:

* Direct admission to trauma center
* ≤ 3h after trauma
* ISS ≥ 16
* Received at least 1L of fluid at ER entrance

Exclusion Criteria:

* Isolated head injury
* Isolated spine injury
* Chemotherapy within the last month
* Hematologic disease
* Chronic hemodialysis
* Uricase treatment within the last week
* Expected death within 48h

Primary outcomes:
measure: Feasibility of serial plasmatic uric acid sampling after trauma
timeFrame: 7 days
Secondary outcomes:
measure: Impact of resuscitation on uric acid measures
timeFrame: 24 to 48 hours
measure: Clinical predictors of the first blood uric acid (μmol/L) level measured
timeFrame: 12 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
Study officials:
References: