louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03734471: Reactor Thoracostomy
Official title: Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pneumothorax
Hemothorax
Lead sponsor: Crozer-Keystone Health System
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 54
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: Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.

Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.


Eligibility criteria: Inclusion Criteria:

1. Subjects age ≥ 18 years old
2. Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
3. Hemodynamically stable

Exclusion Criteria:

1. Pregnant patients
2. Prisoners
3. Need for emergency thoracostomy
4. Hemodynamic instability
5. Respiratory distress

Primary outcomes:
measure: Patient report of pain
timeFrame: During procedure
Secondary outcomes:
measure: Procedure time
timeFrame: During procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01984307: A Retrospective Swedish Cohort Study on Health Outcomes, Life Expectancy, Resource Use and Costs in Patients With a History of Myocardial Infarction and Additional Risk Factors for Atherothrombosis
Official title: A Retrospective Swedish Cohort Study on Health Outcomes, Life Expectancy, Resource Use and Costs in Patients With a History of Myocardial Infarction and Additional Risk Factors for Atherothrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
Myocardial infarction
retrospective
cohort study
Healthcare resources utilization
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with acute coronary syndrome with a history of MI 1-3 years ago.

Brief summary: To characterize and estimate the size of different populations with a history of acute coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality rates healthcare resource utilization and atherothrombotic events) among patients with a history of myocardial infarction (MI) 1-3 years ago and additional risk factors for atherothrombosis.


Eligibility criteria: Inclusion Criteria:

- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion Criteria:

- Not applicable

Primary outcomes:
measure: Description of study population in terms of death, cardiovascular disease events and health care resource utilization
timeFrame: Follow up period 1-7 years
measure: Assessment of the burden of illness among high risk patients with a history of MI
timeFrame: Follow up period 1-7 years
measure: Assessment of the mortality rates among high risk patients with a history of MI
timeFrame: Follow up period 1-7 years
Secondary outcomes:
measure: Description of the high risk patient population in terms of CVD events, bleedings and co-morbidities.
timeFrame: Follow up period 1-7 years
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Research Site
Study officials:
affiliation: Department of Cardiology, Linköping University Hospital, S-581 85 Linköping, Sweden
name: Magnus Janzon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janzon M, Henriksson M, Hasvold P, Hjelm H, Thuresson M, Jernberg T. Long-term resource use patterns and healthcare costs after myocardial infarction in a clinical practice setting: results from a contemporary nationwide registry study. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):291-298. doi: 10.1093/ehjqcco/qcw019.
Clinical trial NCT01949207: RCT - Does Treating Incompetent Perforators Reduce Recurrence?
Official title: Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Keywords: Incompetent perforating veins
EVLA
Phlebectomies
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 190
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 aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.


Eligibility criteria: Inclusion Criteria:

* Primary varicose veins caused by great saphenous vein reflux
* At least one incompetent perforating vein refluxing into the varicosities
* Over 18 years of age

Exclusion Criteria:

* Reflux from pelvic vein origin or small saphenous vein
* Previous varicose vein surgery,
* Incompetent perforators remote from the varicosities treated,
* Deep vein incompetence
* Deep vein obstruction or occlusion

Primary outcomes:
measure: Differences in the level of significant recurrence between the two treatment pathways
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Secondary outcomes:
measure: Differences in insignificant recurrence between the two treatment pathways
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
measure: Patient reported symptom severity
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
measure: Patient reported quality of life
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
measure: Patient satisfaction with treatment.
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
measure: Clinician reported severity of symptoms
timeFrame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
Study officials:
affiliation: The Whiteley Clinic
name: Mark S Whiteley, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01577407: Non Opioid Treatment for Experimental Dyspnea
Official title: Non Opioid Treatment for Experimental Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspnea
Pain
Keywords: Dyspnea
Pain
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.

Detailed description: Dyspnea and pain share many features. One of them is the counterirritation phenomenon: defined in pain research as the attenuation of one pain by another pain. Dyspnea induced with inspiratory threshold loading (increased sense of work/effort ) has been shown to attenuate electrical pain as shown through nociceptive flexion reflex inhibition, or thermal pain, as measured with cortical evoked responses (laser evoked potentials-LEP).

The investigators will study whether nefopam modulates the counterirritation of laboratory induced dyspnea in healthy subjects. The effect of nefopam on experimental dyspnea will be measured with a visual analog scale (VAS) and a validated multidimensional dyspnea profile (MDP). The effect of treatment on counterirritation will be measured by recording LEP obtained using a CO2 laser system. The amplitude of the N2-P2 component of the LEP is the main study outcome.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-smoking

Exclusion Criteria:

* acute or chronic pain
* antalgic or psychoactive drugs use
* nefopam hypersensibility
* severe allergy
* diabetes
* glaucoma
* prostate adenoma
* seizure disorder or convulsion history
* heart or circulation disease
* pulmonary disease or asthma
* kidney or liver disease
* brain or nerve disease
* lack of adhesion to no antalgic drug, alcohol, coffee and cola within previous experiment day consumption

Primary outcomes:
measure: variation of N2-P2 (components of laser evoked potential - tool of pain measurement)amplitude with inspiratory loading induced by intervention
timeFrame: Change from baseline to 1 hour and half from intervention
Secondary outcomes:
measure: variation of subject rating of breathing discomfort (dyspnea)
timeFrame: Change from baseline to 1 hour and half from intervention
measure: variation of N20-P25 amplitude (components of somesthesic evoked potential (SEP) -measurement of sensitivity)
timeFrame: Change from baseline to 1 hour and half from intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Capucine Morelot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01712607: Preoperative Warm-up in Gynecologic Surgery
Official title: Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gynecologic Disorders
Keywords: laparoscopy
surgery
warm-up
preoperative
surgical skills
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background and Objectives: All modern surgical procedures require a high level of cognitive and psychomotor skills achieved using different training methods, but could be influenced by fatigue and other psychological factors. We evaluate the effect of warm-up exercises on operative laparoscopic performances in gynecologic laparoscopic procedures.

Methods: The surgical team operates on a consecutive series of 20 patients and perform laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to be operated on without warm-up exercises and group B to be operated on after a short-term warm-up. All patients are operated on by the same surgical team. The full-time records of the operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and assessed by 2 independent observers using the generic OSATS rating scale. A training module using the Lap Sim simulator was designed for the warm-up.


Eligibility criteria: Inclusion Criteria:

* residents or faculty at the Dept. of Gynecology and Obstetrics
* completed skills training

Exclusion Criteria:

* none

Primary outcomes:
measure: Surgical performance
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria
Study officials:
affiliation: Medical University of Vienna
name: Stephan Polterauer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polterauer S, Husslein H, Kranawetter M, Schwameis R, Reinthaller A, Heinze G, Grimm C. Effect of Preoperative Warm-up Exercise Before Laparoscopic Gynecological Surgery: A Randomized Trial. J Surg Educ. 2016 May-Jun;73(3):429-32. doi: 10.1016/j.jsurg.2015.11.017. Epub 2016 Jan 14.
Clinical trial NCT01409707: Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
Official title: Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Posttraumatic Stress Disorder
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2011-08-04
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.


Eligibility criteria: Inclusion Criteria:

* Current PTSD
* Current Alcohol Dependence
* at least one heavy drinking day in the past 60 days

Exclusion Criteria:

* Psychotic disorder
* Untreated bi-polar disorder
* benzodiazepine use

Primary outcomes:
measure: Impact of Event Scale-Revised
timeFrame: 3-months posttreatment
measure: Timeline Follow Back
timeFrame: 3-months posttreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Scott F. Coffey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476307: Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above
Official title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Flu vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged 18 years or above;
* Non-childbearing or using adequate contraception;
* Written informed consent obtained from the subject.

Exclusion Criteria:

Subjects must not:

* Participate in a trial or using non-registered product;
* Use immunosuppressants, blood products, or another influenza vaccine during study;
* Have virologically confirmed influenza within 1 year;
* Have allergic or acute disease;
* Have unstabilized serious chronic disease;
* Be a lactating female.

Primary outcomes:
measure: Immune response 21 days post vaccination
Secondary outcomes:
measure: Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01264107: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Official title: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine

Brief summary: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.


Eligibility criteria: Inclusion Criteria:

1. Patients is currently clevudine treatment.
2. Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
3. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patient is pregnant or breast-feeding.
3. Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
4. Patient, in the opinion of the investigator, unsuitable for the study.
5. Showing Muscle-related Symptom who any other evidence.

Primary outcomes:
measure: Proportion of patients with sustained antiviral activity effect
timeFrame: at week 48
Secondary outcomes:
measure: The change of sAg
timeFrame: at week 48
measure: Proportion of sAg loss
timeFrame: at week 48
measure: The change of HBV DNA form the baseline
timeFrame: at week 48
measure: Proportion of patients with ALT normalization
timeFrame: at week 48
measure: Proportion of HBeAg loss/seroconversion
timeFrame: at week 48
Other outcomes:
Locations:
city: Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do
country: Korea, Republic of
facility: Soon Koo Baik
Study officials:
References:
Clinical trial NCT01589107: A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
Official title: A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Trauma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Detailed description: Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical surrogates of the following patients will be eligible to participate in this opinion survey:

  1. All patients admitted to the SICU and not expected to die within 48 hours.
  2. Patient has been admitted to the acute care surgical service,
  3. The patient is over the age of 50 and does not have decision making capacity.
* Subjects must be over the age of 21 and English speaking to participate in the opinion survey.

Exclusion Criteria:

Primary outcomes:
measure: knowledge of risks and benefits of procedures
timeFrame: 5 minutes after survey
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Angelo Volandes
role: PRINCIPAL_INVESTIGATOR
References: