louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02315937: Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
Official title: Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hypotension
Hypovolemia
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 35
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: adult patients undergoing spinal anesthesia for minor surgery below the umbilicus

Brief summary: Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This hypotension is often treated with fluid infusion. However, especially in elderly patients, high volume fluid infusion can lead to fluid overload.

The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known. Hence, therapy for hypotension after spinal anesthesia might not be adequate. With transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to monitor fluid responsiveness and guide fluid management.

Objective: This study has two main objectives. The first is to explore the effects of spinal anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter and collapsibility. The second goal is to test the interrater variability transthoracic echocardiography exams when performed by (trained) anesthesiologists.

Furthermore, the correlation between vena cava inferior collapsibility and the occurence and degree of hypotension (defined as a decrease from baseline of \>20% or a systolic pressure \< 90 mmHg) after spinal anesthesia will be explored.


Eligibility criteria: Inclusion Criteria:

* Adult age (\>18 years)
* Written informed consent
* Minor surgery under the umbilicus, e.g. herniorrhaphy, transurethral resection of bladder or prostate, orthopaedic procedures
* ASA class I or II

Exclusion Criteria:

* No informed consent
* ASA class III or higher
* Obstetric surgery
* Emergency procedures
* Pre-existing neurological injury or disease
* Contra-indications for spinal anesthesia (e.g. coagulation abnormalities)

Primary outcomes:
measure: vena cava inferior collapsibility (in %)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Arthur Bouwman, PhD
role: STUDY_DIRECTOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Harm Scholten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986037: Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Adverse events
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers:

  1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
  2. BMI 18 to 29, inclusive.
* Mild asthma patients:

  1. Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for \> or = to 6 months
  2. A condition of good health (than mild to moderate asthma) based upon the results of medical history, physical examination, vital signs laboratory profile and EDG.
  3. BMI 18 to 34, inclusive.

Exclusion Criteria:

1. Asthma exacerbation within 8 weeks of Study Day 1.
2. Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
3. History of allergic reaction or significant sensitivity to constituents of study drug.
4. Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
5. Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
6. Current enrollment in another clinical study.

Primary outcomes:
measure: Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
timeFrame: 12 weeks after last dose
Secondary outcomes:
measure: Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
timeFrame: 12 weeks after last dose
measure: Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
timeFrame: 12 weeks after last dose
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Andrew Campbell, MD
role: STUDY_DIRECTOR
References:
citation: Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K. RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 alpha1 and alpha2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study. Adv Ther. 2017 Jun;34(6):1364-1381. doi: 10.1007/s12325-017-0525-8. Epub 2017 Apr 28.
Clinical trial NCT00246337: A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Official title: A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.


Eligibility criteria: Inclusion Criteria:

* Patient has at least 1 year history of migraine (with or without aura)
* Females of childbearing years must use acceptable contraception throughout trial
* Patient is in general good health based on screening assessment

Exclusion Criteria:

* Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
* Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
* Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
* Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has a history of cancer within the last 5 years

Primary outcomes:
measure: Pain Relief at 2 Hours
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Pain Freedom at 2 Hours
timeFrame: 2 hours post dose
measure: Sustained Pain Relief
timeFrame: 2-24 hours post dose
measure: Sustained Pain Freedom
timeFrame: 2-24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.
Clinical trial NCT03935737: Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients
Official title: Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest X-ray for Clinical Evaluation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2019-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in clinic.

Brief summary: The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.


Eligibility criteria: Inclusion Criteria:

* Standard weight/height outpatients who require two X-ray exams within 3 months in the US
* BMI is \>5% and \< 85% for participants over the age of 2;for participants less than 2 weight for length will be measured

Exclusion Criteria:

* Obese and underweight children as defined as BMI ,\<5% or \>85% according the World Health Organization growth chart for participants over 2 years of age; and for participants less than 2 years of age,weight for length will be measured

Primary outcomes:
measure: Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark
timeFrame: baseline
measure: Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark
timeFrame: within 3 months
measure: Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters
timeFrame: baseline
measure: Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters
timeFrame: within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Susan D John, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799537: Comparing the Stanford Letter Project Form to Traditional Advance Directives
Official title: Comparing the Stanford Letter Project Form to Traditional Advance Directives
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advance Directives
Palliative Care
Keywords: supportive care
palliative care
goals of care
advance care planning
advance directives
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for patients.

Detailed description: Step1: Any adult participant who is interested in completing advance directives and able to read and write in English and or Spanish will be eligible to participate in the study

Step 2:

Online Stanford consent form will be presented before the participants. Only after they read the consent and click on the participation link will they be able to enter the study.Those who are willing to participate will be randomly assigned to either the letter or traditional advance directives in Spanish and study measures. They will also answer questions as to how much they liked and understood the documents.

Step 4: The investigators will collect data until the investigators reach an n=1000

Step 5: The investigators will analyze the results and submit for publication.

In this protocol, we are assessing whether patients prefer the traditional advance directives or the letter directive. As it is just an questionnaire based study, there no risk for patients.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Ease of use of Questionnaire. more patient-centered and family oriented
timeFrame: 1year
Secondary outcomes:
measure: Ease of use to describe how decisions are made
timeFrame: 1year
measure: Ease of use about the type of treatment and care.
timeFrame: 1year
measure: Ease of use about letting my doctors about my wishes.
timeFrame: 1 year
measure: Ease of use if I cannot make decisions for myself then the form says it.
timeFrame: 1 year
measure: Ease of use about my future preferences.
timeFrame: 1 year
measure: Ease of use of the form itself.
timeFrame: 1 year
measure: Ease of use and the comments participants may have.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: VJ Periyakoil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524637: The Utility of Thromboelastography in Traumatic Brain Injury
Official title: The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Coagulation Disorder
Keywords: Thrombelastography
Coagulation Disorder
Traumatic Brain Injury
Coagulation-related damages
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (18-80 years old) with isolated traumatic brain injury, who are admitted within 24 hours post-injury are included. To avoid interfering factors, patients with existing prior neurological disease or known coagulation disorders, patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma or receiving blood components prior to blood draw, patients who deteriorate and die before determining whether coagulation-related damage exists are excluded. Clinical data are documented, including age, gender, mechanisms of trauma, types of lesions as evidenced by imaging examination and laboratory examination, etc.

Brief summary: Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* Patients who are delivered to hospital within 24 hours after head trauma
* Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury

Exclusion Criteria:

* Patients with existing prior neurological disease
* Patients with known coagulation disorders
* Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
* Patients receiving blood components prior to blood draw
* Patients who deteriorate and die before determining whether coagulation- related damage exists

Primary outcomes:
measure: Glasgow Outcome Scale scores
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Hao Chen, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00161837: Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004
Official title: Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: Influenza
Vaccine
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.


Eligibility criteria: Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* are \>= 18 and \<= 60 years old (for Stratum A only);
* are \> 60 years old (for Stratum B only);
* are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
* will reliably keep a daily record of symptoms;
* understand the nature of the study, agree to its provisions, and give written informed consent;
* if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Male and female subjects will be excluded from participation in this study if they:

* have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
* suffer from any kind of immunodeficiency;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
* have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
* have received a blood transfusion or immunoglobulins within one month of study entry;
* have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
* have a rash or dermatological condition which may interfere with injection site reaction rating;
* have a known or suspected problem with drug or alcohol abuse;
* are unable to lead an independent life either physically or mentally;
* had administration of an investigational drug within six weeks prior to the study start;
* are concurrently participating in a clinical trial;
* are pregnant or lactating.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: PANTAMED Sp.z o.o.
Study officials:
affiliation: PANTAMED sp. z o o.
name: Jerzy Romaszko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747237: Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
Official title: Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: edema
third molar
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the correlation between two point distance measurements performed by surgeon on patients face with foldable ruler, which is the most commonly used method, and the subjective scoring will be done by the patient with the help of the edema scale, for measuring edema.

Detailed description: The patients will be selected among the patients who apply for mandibular impacted third molar extraction to Necmettin Erbakan University, Faculty of Dentistry. A total of 60 patients will be included. All third molar operations will be carried out by the same surgeon in all groups with the same technique.Two methods will be used to evaluate the edema on the face.

1. Method The surgeon will measure from three different places on the patient's face ( two point distance) with the help of a paper ruler.

   * Tragus-Pogonion
   * Tragus-Labial Komissura
   * Angulus Mandibula-Lateral Kantus Measurements will be made preoperative, postoperative 2. and 7. days and saved as milimetre.
2. Method Patients will be given edema scale.With the help of the edema scale, the patients will be evaluated the edema by themselves. When the patient stand in front of the mirror, they will be assessed the edema on their face. And a value between 0 and 4 will be pointed on the scale postoperative 2. and 7. days.

A correlation between the results of the first and second methods will be examined.

Eligibility criteria: Inclusion Criteria:

* Impacted mandibular third molar teeth (mesioangular, mucosa and bone retantion)
* Patients with any chronic disease and allergy

Exclusion Criteria:

* Smoking
* Pregnancy or lactation
* pericoronitis

Primary outcomes:
measure: Tragus-pogonion measurement will be made with paper ruler.
timeFrame: Up to 1week
measure: Tragus-labial comissura measurement will be made with paper ruler.
timeFrame: Up to 1week
measure: Angulus mandible-latheral cantus will be made with paper ruler
timeFrame: Up to 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
state: Karatay
Study officials:
affiliation: Necmettin Erbakan University
name: Dilek Menziletoglu
role: PRINCIPAL_INVESTIGATOR
References: