louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04437342: Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia
Official title: Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Psychological Stress
Maternal Distress
Keywords: postpartum depression
Covid-19 pandemic
anaesthesia
Lead sponsor: General and Maternity Hospital of Athens Elena Venizelou
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Alexandra Hospital, Athens, Greece
name: University of Ioannina
name: Larissa University Hospital
First posted: 2020-06-18
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women admitted to the hospital for vaginal delivery or caesarean section

Brief summary: The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables


Eligibility criteria: Inclusion Criteria:

* All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)

Exclusion Criteria:

* Not eligible in writing and reading in Greek
* Drug abuse

Primary outcomes:
measure: Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)
timeFrame: 40 days postpartum
Secondary outcomes:
measure: Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)
timeFrame: 10 minutes postpartum
measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
timeFrame: 2 minutes prior to discharge from the Postanaesthesia care unit
measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain
timeFrame: 2 minutes after admission to the Postanaesthesia care unit
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Elena Venizelou" General and Maternity Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: Aretaieio University Hospital
state: Attica
city: Athens
country: Greece
facility: Alexandra Genaral Hospital Athens
city: Ioannina
country: Greece
facility: University of Ioannina Health Science
city: Ioannina
country: Greece
facility: University of Ioannina, Medical School
city: Larisa
country: Greece
facility: University of Thessaly Medical School
Study officials:
affiliation: Elena Venizelou General and Maternity Hospital of Athens, Greece
name: Georgia Micha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531842: A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye
Official title: Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Retinal Vein Occlusion
Choroidal Neovascularization
Age-related Macular Degeneration
Branch Retinal Vein Occlusion
Keywords: Conjunctival bacterial flora
prophylactic topical antibiotic
injection
intravitreal injection
bacterial resistance
serial injection
serial intravitreal injections
CNV
CRVO
AMD
BRVO
Lead sponsor: Mid Atlantic Retina
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

Detailed description: The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.

Eligibility criteria: Inclusion Criteria: Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Have been diagnosed with neovascular AMD, CRVO or BRVO.
* Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.

Exclusion Criteria: Subjects meeting any of the following criteria are ineligible for study entry:

* Prior intraocular injection in either eye.
* Chronic use of opthalmic medication.
* Contact lens wear.
* Ocular surgery within the past 6 months.
* Use of ophthalmic medications in either eye or ocular infection within the past 6 months.
* Use of systemic antibiotics within 6 months.
* Known allergy or contraindication to povidone iodine or fluoroquinolones.

Primary outcomes:
measure: Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.
timeFrame: Prior to each of your eye injections for the first 4 injections and continue through the completion of your fourth injection, an anticipated maximum of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Mid Atlantic Retina
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02055742: Detection of Chlamydia (CT) and Gonorrhea (NG)
Official title: Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia
Gonorrhea
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-05
Enrollment: 700
Sex: ALL
Minimum age (years): 14
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic and asymptomatic subjects at least 14 years of age

Brief summary: To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.


Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Any ethnicity or race
3. Subject \>14 and \<89 years of age
4. Subject who voluntarily gives written informed consent; not applicable for leftover specimens
5. Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
6. Leftover urine specimens

Exclusion Criteria:

1. Subjects \< 14 or \>90 years of age
2. Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
3. Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
4. Individuals who have been on antibiotic medications within 10 days.
5. Multiple sets of specimens from the same subject at different office visits
6. Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
7. Frozen archived specimens

Primary outcomes:
measure: Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
timeFrame: Up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Philadelphia
country: United States
facility: Planned Parenthood Southeastern PA
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00833742: Intensive Short-term Dynamic Psychotherapy (ISTDP) in the Emergency Department
Official title: Emotion-focused Diagnosis and Treatment of Somatization in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatic Complaints of Multiple Types
Keywords: somatization
psychosomatic
short-term
dynamic
psychotherapy
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Somatization of emotions accounts for excess Emergency department (ED) visits. Intensive Short-term Dynamic Psychotherapy (ISTDP) has methods to diagnose and manage somatization. We examined the feasibility, acceptability and effectiveness of ISTDP diagnostic and treatment methods used for patients with repeated ED presentations for medically unexplained physical symptoms (MUS)

Detailed description: Herein we report the methods and outcomes of rapidly-accessed, emotion-focused diagnostic and treatment services for patients presenting to the ED with medically unexplained symptoms (MUS). Patients who were assessed and referred by ED physicians will serve as a non-randomized condition controlling for some relevant variables. Our a priori hypotheses were that assessed and treated patients would have a reduction in ED visits and self reported symptoms after this intervention and that controls would have a smaller reduction in ED visits if any.

Eligibility criteria: Inclusion Criteria:

* Unexplained symptoms

Exclusion Criteria:

* Psychosis, substance abuse, suicidality

Primary outcomes:
measure: Emergency department visits pre and post
timeFrame: 1 year
Secondary outcomes:
measure: Brief Symptom Inventory
timeFrame: pre and post
measure: Patient Satisfaction
timeFrame: post
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Allan A Abbass, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbass A. Somatization: Diagnosing it sooner through emotion-focused interviewing. J Fam Pract. 2005 Mar;54(3):231-9, 243. No abstract available.
Clinical trial NCT04304742: Radiologist Diagnostic Performance Versus Artificial Intelligence (AI)
Official title: Retrospective Study Comparing Radiologist Diagnostic Performance Versus Artificial Intelligence (AI) for Hip Fracture Suspicion in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Painful Hip
Fonctional Impotence After Minor Trauma (Fall)
Keywords: Medical imaging diagnosis
Frature detection
Artificial intelligence
Femoral neck fracture
Hip
X-ray
Radiography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 60 and older, admitted to emergency department for painful hip/fonctional impotence after minor trauma.

Patients take at least a hip radiography

Brief summary: In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation).

However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department.

Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis.

The Artificial intelligence (AI) begins study the detection of fratures on medical imaging.

In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department.

AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.


Eligibility criteria: Inclusion criteria:

* Patients aged 60 and older
* Minor trauma
* Admitted in emergency department for painful hip/fonctional impotence after minor trauma
* Takes at least a hip radiography

Exclusion criteria:

* Painful before the minor trauma
* Important trauma

Primary outcomes:
measure: Detection rate of femoral neck fracture
timeFrame: 1 day
Secondary outcomes:
measure: Detection rate of other hip fracture
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Catherine CYTEVAL, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03488342: Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
Official title: Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Inguinal Hernia
Keywords: Rives technique
Lichtenstein repair
Lead sponsor: Hospital Siberia-Serena
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized,controlled and double-blind study
Primary purpose: TREATMENT

Brief summary: Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.

Detailed description: These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

Eligibility criteria: Inclusion Criteria:

Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit.

They must provide signed written informed consent and agree to comply the study protocol

Exclusion Criteria:

Refusal to give informed consent. Refusal to participate giant inguinal hernias

Primary outcomes:
measure: Evaluate postoperative complications of pain
timeFrame: 7 days
Secondary outcomes:
measure: Evaluate the chronic pain
timeFrame: 1 year
measure: Evaluate the recurrences
timeFrame: 1 year
Other outcomes:
Locations:
city: Talarrubias
country: Spain
facility: Hospital Siberia Serena
state: Badajoz
Study officials:
References:
Clinical trial NCT05271942: Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
Official title: Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Divide and Conquer, Tilt and Tumble
Lead sponsor: Aleris Eye
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into two groups
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.

Detailed description: After being informed about the study and potential risks, all participants who have signed the written informed consent will be randomized to undergo cataract surgery with either the method called "Divide and Conquer" or "Tilt and Tumble". Pre- per- and postoperative measurements from the surgery will be filed and compared later on by the investigator.

Eligibility criteria: Inclusion Criteria:

* Cataract

Exclusion Criteria:

* Dementia
* Very narrow anterior chamber
* Born after 1965

Primary outcomes:
measure: Differences in energy during phacoemulsification between the methods investigated.
timeFrame: Immediately after the surgery
measure: Differences in time used during phacoemulsification during surgery between the methods investigated
timeFrame: Immediately after the intervention/procedure/surgery
measure: Difference in corneal endothelial cell density after cataract surgery between the study groups investigated. Before and after surgery. Change is being assessed.
timeFrame: Pre-intervention surgery and 14 days after surgery.
measure: Measurement of clinical och subclinical macular oedema before and after surgery. Change is being assessed.
timeFrame: Pre-intervention surgery and 14 days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Aleris Eye Clinci
state: Skåne
city: Malmö
country: Sweden
facility: Aleris Eye Clinic
state: Skåne
Study officials:
References:
Clinical trial NCT02095470: Video Laryngoscope, New Intubation Device
Official title: Advanced Video Laryngoscope, a New Practical Intubation Device: Randomized Clinical Trial in 401 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Elective Intubation
Keywords: Laryngoscopy
Equipment
Video Laryngoscope
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Education Development Center, Inc.
First posted: 2014-03-24
Enrollment: 401
Sex: ALL
Minimum age (years): 19
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: new glidoscope was tested on 401 patients

Detailed description: Four hundred and one patients who were scheduled for elective operation, were randomly assigned to be intubated by direct laryngoscopy using a Macintosh blade size 3rd (DL, n=196) or intubation using the video laryngoscope (VL, n=205). Prior to intubation all patients were given a similar regimen of induction of anesthesia. The patients were then intubated, using direct laryngoscopy or the VL, by a different anesthetist during which the larynx was inspected and given a laryngoscopy score. Time to intubate, failure rate, injuries, personnel pleasure and, aspiration rate were measured

Eligibility criteria: Inclusion Criteria:

* elective operation who filled the consent

Exclusion Criteria:

* poor intubation
* emergency cases
* hemodynamic derangement

Primary outcomes:
measure: laryngoscopy grade
timeFrame: hospital stay (average 48 hours)
measure: time to intubation
timeFrame: 60 minutes
measure: unsuccessful attempts
timeFrame: 60 minutes
Secondary outcomes:
measure: aspiration
timeFrame: hospital stay ( 48 hours)
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz Universty of Mesical Sciences
state: Fars
Study officials:
References:
Clinical trial NCT05683470: Expanded Access RBS2418 Treatment
Official title: Expanded Access to RBS2418 for an Individual Patient With Pancreatic Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Expanded Access in Pancreatic Cancer
Lead sponsor: Riboscience, LLC.
Sponsor class: INDUSTRY
Collaborators: name: Dr. Bertrand Tuan
First posted: 2023-01-13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.

Detailed description: Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418

Eligibility criteria: Inclusion Criteria:

* The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.

Exclusion Criteria:

* Not applicable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pacific Hematology and Oncology Associates
name: Bertrand Tuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302470: Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy
Official title: Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Heart Failure
Keywords: biventricular pacing
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2011-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

Detailed description: A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Eligibility criteria: Inclusion Criteria:

* Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
* QRS interval greater than or equal to 130 msec
* Left ventricular end diastolic diameter greater than or equal to 55 mm
* left ventricular ejection fraction less than or equal to 35
* Willingness to participate

Exclusion Criteria:

* Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
* untreated active infection
* acute stroke
* severe uncontrolled systemic hypertension
* severe systemic electrolyte imbalance
* severe concomitant illness that drastically shortens life expectancy
* severe coagulopathy
* history of severe COPD and inability to tolerate single lung ventilation
* History of prior left sided thoracotomy
* history of recent intravenous drug use
* concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
* participation in another investigational protocol

Primary outcomes:
measure: CHF Hospitalizations & mortality
timeFrame: one year post implant.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St.Lukes-Roosevelt Hospital
state: New York
Study officials:
References: