louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02266212: A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking
Official title: The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Current Smokers
Past Smokers
Never Smokers
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.

Exclusion Criteria:

* the patients undergoing major thoracic cardiovascular surgery
* the patients with significant lung lesion
* the patients with conscious disturbance
* the patients with allergic history to morphine

Primary outcomes:
measure: Fagerstrom test for nicotine dependence
timeFrame: Post-operation Day1 to Day4
Secondary outcomes:
measure: Differences in pain intensity between the three groups after postoperative analgesia.
timeFrame: Post-operation Day1 to Day4
Other outcomes:
measure: Morphine consumption
timeFrame: Post-operation Day1 to Day4
measure: side effects
timeFrame: Post-operation Day1 to Day4
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References:
Clinical trial NCT00483912: Albumindialysis in Acute Pancreatitis
Official title: Molecular Adsorbent Recirculating System (MARS) in Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pancreatitis
Multiple Organ Failure
Keywords: pancreatitis, MARS
severe acute pancreatitis with early multiple organ failure
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-06-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The incidence of acute pancreatitis has been doubled during last three decades in Finland. Alcohol is the main cause of acute pancreatitis in Finland accounting for 70 % of cases. Although the mortality of acute pancreatitis has been decreased it still appears and especially early multiple organ failure is the main cause of all deaths. Multiple organ failure in the early course of the disease is thought to be caused by the release of cytokines. Molecular adsorbent recirculating system (MARS) has shown to decrease mortality in acute alcohol hepatitis and paracetamol intoxication. Also it has been shown to improve kidney function due to hypoperfusion and tubulus necrosis and overrule decrease mortality in patients with multiple organ failure due to different reasons. A part of patients with acute alcoholic pancreatitis may have so-called fat liver already on admission. It has been shown that the highest mortality is especially associated those with early liver and kidney failure. MARS treatment has never earlier been used in the patients with acute alcoholic pancreatitis and early organ failure. In this study we randomize patients with acute alcoholic pancreatitis and early multiple organ failure (Sofa score\>2) to two groups: 1) Standard pancreatitis treatment in intensive care unit and 2) Standard pancreatitis treatment in intensive care unit with 5 MARS sessions.


Eligibility criteria: Inclusion Criteria:

* Severe acute alcoholic pancreatitis with early multiple organ failure (Sofa score \>2)

Exclusion Criteria:

* If patient or his/her family member refuses, pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Dept. of Gastroenterology and Alimentary Tract Surgery
name: Sari Räty
role: STUDY_CHAIR
References:
Clinical trial NCT04776512: Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
Official title: Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia in Labor
Keywords: analgesia, vaginal delivery, ESP, EPIDURAL
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

* ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
* Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

Detailed description: Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

* ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
* Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision.

Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space.

For the 2 groups, analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score (VAS).

Eligibility criteria: Inclusion Criteria:

* Full termed parturients admitted for vaginal delivery
* singleton pregnancy
* No contraindications to perimedullar analgesia techniques

Exclusion Criteria:

* Indication to Cesarean section during labor period

Primary outcomes:
measure: Analgesia during labor
timeFrame: change in VAS score 1 hour after the beginning of labor
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02943512: Same Day Discharge
Official title: Same Day Discharge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.

Detailed description: Subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. Both groups will under go standard of care assessments prior to discharge. The same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. Both groups will be seen 10 - 14 days after implant for further evaluation.

The subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.

Eligibility criteria: Inclusion Criteria:

1. Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator
2. Willing and able to provide informed consent
3. Appropriate clinical indication for the purpose of this study

   1. Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20%
   2. Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant.
   3. No history of syncope
   4. No documented sudden cardiac death or ventricular arrhythmias requiring shock
4. Adequate social support to be able to comply with protocol.
5. Ability to complete remote monitor transmission

Exclusion Criteria:

1. Determined to be at risk for bleeding or on oral anticoagulation 2. Planned to be implanted with non-Biotronik device 3. Complete heart block as indication for permanent pacemaker 4. Secondary ICD indication 5. Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.

-

Primary outcomes:
measure: Average number of late complications between the 2 arms
timeFrame: up to 2 weeks after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Alexandru Costea, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05703412: Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness
Official title: Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bipolar Disorder
Major Depression
Schizophrenia
Keywords: mHealth
psychiatric hospitalization
transitions of care
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brown University
First posted: 2023-01-30
Enrollment: 180
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 overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.


Eligibility criteria: Inclusion Criteria:

* psychiatric inpatient/partial hospitalization
* diagnosis of schizophrenia-spectrum disorder or major mood disorder
* planned ongoing mental health treatment post-discharge in the community
* 18 years or older
* ability to speak and read English

Exclusion Criteria:

* lack of smartphone
* homelessness or housing instability that would prevent reliable follow-up
* discharge to a long-term restricted living setting

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
measure: Recovery Assessment Scale (RAS)
timeFrame: 24 weeks
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Ethan Moitra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02872012: Cryoanesthesia for Intravitreal Injections
Official title: Cryoanesthesia for Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Anesthesia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the surface of the eye immediately prior to intraocular injections.

The investigators plan to carry out a pilot study to collect preliminary data on the effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal injections (IVT).


Eligibility criteria: Inclusion Criteria:

* Bilateral macular disease due to either exudative macular degeneration or diabetic retinopathy requiring bilateral intravitreal injections
* Have had at least one prior intravitreal injection
* Able to give informed consent

Exclusion Criteria:

* Unilateral disease
* Unable to provide consent
* Preexisting conjunctival, episcleral or scleral defects or disease

Primary outcomes:
measure: Subjective Injection Pain
timeFrame: Immediately following the intravitreal injection
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: Instructor in Ophthalmology and Visual Sciences
name: Anjali R Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besirli CG, Smith SJ, Zacks DN, Gardner TW, Pipe KP, Musch DC, Shah AR. Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections. Ophthalmol Retina. 2020 Oct;4(10):979-986. doi: 10.1016/j.oret.2020.04.001. Epub 2020 Apr 15.
Clinical trial NCT02110212: Femtosecond Laser for Cataract Surgery
Official title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract
Surgery, cataract extraction
Optical devices, laser
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.


Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with the treatment/follow-up schedule and requirements
* Able to understand and provide written Informed Consent
* ETDRS visual acuity equal to or worse than 20/32 (best corrected)
* Age between 50 and 80 years old
* Pupil dilates to at least 6 mm
* Subject able to fixate
* Grade 1-4 nuclear sclerotic cataract (LOCS III)
* Axial length between 22 and 26 mm

Exclusion Criteria:

* Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
* Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
* Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
* History of prior ocular surgery
* History of ocular trauma
* Co-existing ocular disease affecting vision
* History or current use of alpha-1 antagonist medication (e.g., Flomax)
* Known sensitivity to planned concomitant medications

Primary outcomes:
measure: Capsulotomy Dimension
timeFrame: Day of Surgery
Secondary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day of Surgery
Other outcomes:
Locations:
Study officials:
affiliation: Laser Center
name: Juan F. Batlle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: William W. Culbertson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00682812: Significance of the High-risk Hpv Viral Load
Official title: Significance of the High-risk Hpv Viral Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infections
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.

Detailed description: We will particularly evaluate if the HR-HPV viral load:

* Is correlated to the transcription of the genes of the oncoproteins E6 and E7
* Is predictive of the integration of the virus in infected cells
* Is predictive of the presence of HPV in patients' blood
* Influences the local and systemic immunologic response

Eligibility criteria: Inclusion Criteria:

* The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.
* The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy
* The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.

Exclusion Criteria:

* The patients having a LIEBG
* The patients incapable to receive the information enlightened on the progress and the objectives of the study
* The patients not having signed enlightened assent

Primary outcomes:
measure: Estimate the meaning of a viral load raised in HPV oncogenic
timeFrame: 36 months
Secondary outcomes:
measure: To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
timeFrame: 36 months
measure: Estimate the correlation between the viral load of the HPV oncogenic and the level of transcription of the genes coding for oncoproteines E6 and E7
timeFrame: 36 months
measure: Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells
timeFrame: 36 months
measure: Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Nord, service de gynécologie-obstétrique
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Xavier CARCOPINO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189512: Study on the Effect of Surgical Intestinal Manipulation
Official title: CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Manipulation
Keywords: brain-death organ donors
intestinal manipulation
monocytes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.


Eligibility criteria: Inclusion Criteria:

* patients who are brain death
* patients who undergo an elective abdominal aortic aneurysm repair

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: subtypes of monocytes
timeFrame: 1 day
measure: evaluate effect of intestinal manipulation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
name: Jacques Pirenne, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: