louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04365608: Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment
Official title: Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Intubation; Difficult or Failed
Cardiac Arrest
Influenza
Safety Issues
Keywords: endotracheal intubation
cardiac arrest
personal protective equipment
laryngoscope
Vie Scope
COVID-19
SARS-CoV-2
emergency medicine
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Poznan University of Medical Sciences
name: Wroclaw Medical University
name: Medical University of Bialystok
First posted: 2020-04-28
Enrollment: 90
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 safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Detailed description: Intubation will be carried out in full personal protective equipment conditions of the operator

Eligibility criteria: Inclusion Criteria:

* All adult patients requiring out-of-hospital intubation

Exclusion Criteria:

* Patient under 18 years old
* Patients with criteria predictive of impossible intubation under direct laryngoscopy

Primary outcomes:
measure: Intubation success rate during at the first laryngoscopy
timeFrame: 10 min
Secondary outcomes:
measure: Intubation difficulty Scale score
timeFrame: 10 min
measure: Complications related to tracheal intubation
timeFrame: 10 min
measure: Time to completion of tracheal intubation (TI) procedure
timeFrame: 10 min
measure: Duration of the interruption of chest compression during ETI procedure
timeFrame: 10 min
measure: Laryngeal View during intubation
timeFrame: 10 min
measure: POGO score
timeFrame: 10 min
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Emergency Medical Service
city: Warsaw
country: Poland
facility: Emergency Medical Service
Study officials:
References:
citation: Szarpak L, Peacock FW, Rafique Z, Ladny JR, Nadolny K, Malysz M, Dabrowski M, Chirico F, Smereka J. Comparison of Vie Scope(R) and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment. Am J Emerg Med. 2022 Mar;53:122-126. doi: 10.1016/j.ajem.2021.12.069. Epub 2022 Jan 4.
Clinical trial NCT05878808: Obsessions and Suicidality in Youth With Bipolar 1 Disorder
Official title: Obsessions and Suicide in Youth With Bipolar 1 Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessions
Suicide
Bipolar I Disorder
Obsessive-Compulsive Disorder
Keywords: BSSI
DYBOCS
Bipolar disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54).

Brief summary: Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a comorbidity that is known to increase suicide risk. This study aimed to assess the presence of OCD in youth diagnosed with bipolar I disorder \& to evaluate the association between OCD and suicide in the same cohort.

Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS).

The results revealed that DYBOCS score of group A was 30.23±0.43, \& of group B was 18.50±1.88 with a significant difference (p\<0.01). There was a significantpositive correlation between BSSI and age, age of onset and YMRS in Group A (p\<0.01).

The study demonstrated that OCD is a common comorbidity in youth with bipolar I disorder and may be associated with a greater risk of suicide than in youth with bipolar I disorder without co-morbid OCD. Furthermore, co-morbidity of OCD with bipolar I disorder in youth may be associated with younger age of onset and more severe symptoms profile.


Eligibility criteria: Inclusion Criteria:

- Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder

Exclusion Criteria:

* refused to sign the consent, active manic phase, recent substance use

Primary outcomes:
measure: Association of OCD with bipolar I disorder
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03498508: Poor Theoretical Knowledge and Self-assessed Ability of Cardiopulmonary Resuscitation Among In-hospital Healthcare Professionals: a Cross Sectional Study With Questionnaires.
Official title: Poor Theoretical Knowledge and Self-assessed Ability of Cardiopulmonary Resuscitation Among In-hospital Healthcare Professionals: a Cross Sectional Study With Questionnaires.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In-hospital Cardiac Arrest
Keywords: Cardiopulmonary Resuscitation
Knowledge
In-hospital cardiac arrest
Skills
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Dalarna University
name: Center for Clinical Research Dalarna, Sweden
name: Region Västmanland
First posted: 2018-04-13
Enrollment: 3044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals of all professions working in-hospital with patient contact.

Brief summary: Theoretical knowledge of cardiopulmonary resuscitation (CPR) is the foundation of being able to perform CPR in a cardiac arrest situation. The knowledge and skills received in training is easily lost and after one year the level is equal to pretraining. International studies regarding knowledge of CPR among healthcare professionals, mostly nurses, show poor results. The knowledge of CPR among Swedish healthcare professionals is poorly studied.

The aim of this study was to describe the theoretical knowledge of CPR and self-assessed abilities of performing CPR among healthcare professionals working in four hospitals in Sweden.

Detailed description: A questionnaire will be handed out containing a knowledge test of nine questions at a basic level. The questionnaire also contains Likert-scales that measures four self-assessed CPR abilities of the respondents (the ability to take leadership, give compressions, to ventilate and to defibrillate).

Eligibility criteria: Inclusion Criteria:

* Healtchare professionals of all professions
* Working in-hospital with patient contact
* Present at the time of the survey

Exclusion Criteria:

* Not working with patients
* Abscent at the time of the survey

Primary outcomes:
measure: Factors affecting theorethical knowledge
timeFrame: April 30, 2018
measure: Factors affecting self-assessed abilities.
timeFrame: April 30, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Avesta
country: Sweden
facility: Avesta Lasarett
state: Dalarna
city: Falun
country: Sweden
facility: Falu Lasarett
state: Dalarna
city: Mora
country: Sweden
facility: Mora Lasarett
state: Dalarna
city: Västerås
country: Sweden
facility: Västmanlands sjukhus
state: Västmanland
Study officials:
affiliation: Dalarna County Council
name: Anneli Strömsöe
role: STUDY_DIRECTOR
References:
Clinical trial NCT04600908: Incidence of Commuting Accidents Among Non-physician Staff of a Large University Hospital Center From 2012 to 2016
Official title: Incidence of Commuting Accidents Among Non-physician Staff of a Large University Hospital Center From 2012 to 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accident, Traffic
Keywords: Commuting accident
Traffic accident
Hospital
Descriptive study
Incidence
Health care worker
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 390
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-physician staff working at the Hospices Civils de Lyon and having had commuting accidents between 2012 and 2016

Brief summary: Over the past thirty years, risk of road traffic accidents has decreased but remains high and accounts for 44% of fatal work-related accidents for commuting and mission-related accidents. The aims of this study were to estimate the overall incidence of commuting accidents for non-physician professionals in a major university hospital and by gender and different professional categories, and to assess its evolution over a 5-year period. A descriptive analysis was performed on 390 commuting accidents from 2012 to 2016 extracted from the university hospital's occupational health service.


Eligibility criteria: Inclusion Criteria:

* non-physician staff
* commuting accidents

Exclusion Criteria:

* work accidents
* on-duty road accidents
* physician staff

Primary outcomes:
measure: Incidence of commuting accidents
timeFrame: at the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05716308: The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
Official title: The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetic Retinopathy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: To evaluate the application effect of continuous nursing intervention in type 2 diabetic retinopathy (DR), and to explore its clinical application value. Methods：Patients with type 2 DR admitted to our Hospital from June 2019 to June 2022 were selected as the research objects and divided into intervention group and control group by random number table method. The control group received routine nursing intervention, and the intervention group received continuous nursing intervention on the basis of the control group. The related effect evaluation indexes such as fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin and visual acuity were collected and compared between the two groups at discharge, 1 year and 2 years after discharge. The readmission rate of the two groups was counted to evaluate the effect of continuous nursing intervention.


Eligibility criteria: Inclusion Criteria:

* (1) DR diagnosis and classification criteria in line with the latest version of the 2017 Clinical Guidelines for Diabetic Retinopathy developed by the American Eye Association \[9\];
* (2) Type 2 diabetes course of more than 5 years, with varying degrees of retinopathy;
* (3) Monocular disease, no blindness;
* (4) Education level above primary school; - (5) Patients informed consent for this study and signed a consent form.

Exclusion Criteria:

* (1) with severe cerebral hemorrhage or cerebral infarction, severe nephrotic syndrome, senile dementia, cardiovascular and cerebrovascular diseases;
* (2) Patients with macular edema, severe corneal (and) or lens opacity affect the observation of the fundus, angle-closure glaucoma can not mydriasis, other fundus diseases, and nursing interventions for other chronic diseases. This study was approved by the ethics committee of our hospital.

Primary outcomes:
measure: DR patient care satisfaction questionnaire during follow-up
timeFrame: 2 years
measure: The Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 2 years
measure: Criteria for visual acuity changes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT01070108: Escalating Ketamine Doses and Pre-emption
Official title: EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management
Keywords: Preemption, ketamine, escalating, dose, pain, analgesia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketamine affects postoperative pain when administered intravenously immediately before, during or at the end of surgical procedures. We assessed the effects of multiple and escalating doses of ketamine administered many hours before surgery on postoperative pain and analgesia consumption.


Eligibility criteria: Inclusion Criteria:

Consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia

Exclusion Criteria:

1. allergy to opioids, ketamine or non-steroidal anti-inflammatory drugs (NSAIDs)
2. history of lasting chronic pain or psychiatric disorders or had used opioids or psychotropic drugs of any sort during the past two weeks
3. soldiers and pregnant women

Primary outcomes:
measure: postoperative pain
timeFrame: 48 hours
Secondary outcomes:
measure: opioid drug consumption
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
citation: Rakhman E, Shmain D, White I, Ekstein MP, Kollender Y, Chazan S, Dadia S, Bickels J, Amar E, Weinbroum AA. Repeated and escalating preoperative subanesthetic doses of ketamine for postoperative pain control in patients undergoing tumor resection: a randomized, placebo-controlled, double-blind trial. Clin Ther. 2011 Jul;33(7):863-73. doi: 10.1016/j.clinthera.2011.05.094. Epub 2011 Jul 1.
Clinical trial NCT00799708: A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Keywords: Biomarkers of estrogen receptor beta activation
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 27
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening
* Subject has a normal mammogram at screening
* Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening
* Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow
* Subject is willing to avoid strenuous exercise during the study
* Subject is willing to avoid use of mouthwash or salt water rinses during the study
* Subject is willing to avoid use of teeth whitening products
* Subject is willing to avoid eating and/or drinking grapefruit products
* Subject is willing to limit alcohol consumption to 2 drinks a day
* Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent) per day
* Subject is a non-smoker

Exclusion Criteria:

* Subject has a history of multiple and/or severe allergies to drugs or food
* Subject has a cold or viral infection within 2 weeks of Visit 2
* Subject is taking antibiotics within 2 weeks of Visit 2
* Subject needs dental work or procedures during the study
* Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening
* Subject is unable to discontinue anti-coagulants

Primary outcomes:
measure: Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.
timeFrame: Baseline and Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02221908: ED Decision Making Among Hypotensive Patients
Official title: ED Decision Making Among Hypotensive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Keywords: Systolic Blood pressure < 100 mm Hg
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 200
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: Patients brough to Hahnemann Hospital ED

Brief summary: The goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. The hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive CVP measurement

Detailed description: If physicians can make appropriate decisions about the need for fluid resuscitation without CVP measurement, then this skill is worth being passed to physicians in training. Previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000 System), this study is now practical and safe.

Eligibility criteria: Inclusion Criteria:

* All patients \>=18 years of age who enter the Emergency Department at Hahnemann Hospital with Systolic Blood pressure \< 100 mm Hg

Exclusion Criteria:

* Those patients who are suffering from traumatic injury requiring Level I or Level II trauma evaluations. Example conditions include penetrating injuries to head, torso and proximal extremities.
* Additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral IVs.
* Pregnant females will be excluded.
* Subjects under the age of 18 years will be excluded

Primary outcomes:
measure: The correspondence of resuscitation decision and CVP value
timeFrame: At patient admission to ED
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Neal Handly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04305808: Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
Official title: Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections
Menopause
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menopausal women, with recurrent UTI and age-matched menopausal women without recurrent UTI.

Brief summary: The objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. This will be explored using comparison of microbiome profiles between those with recurrent UTI compared to age-matched women without recurrent UTI.

Detailed description: Patients and age-matched control subjects will be recruited from the Urogynecology clinic in Hadassah Mt Scopus and the gynecology clinic, respectively.

After assessment of inclusion and exclusion criteria and patient's consent to participate, a history intake (detailing demographics, medical history, risk factors for rUTI etc.) and gynecological examination will be conducted as part of the usual assessment in the clinic.

Vaginal, urine and fecal samples for microbiome molecular analysis will be collected during clinic visits, given at least one month without antibiotics before samples collection, using agreed protocols and will be kept for future evaluation. Urine will be collected for urinalysis and for a urine culture.

In addition, urine cultures, as well as vaginal, urine and fecal samples for molecular analysis will be collected during an acute UTI episode from the same patients.

Healthy patients (the control group) will be examined only once.

Eligibility criteria: Patients' inclusion criteria:

* Menopausal status
* Two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year Patients' exclusion criteria
* Neurogenic bladder condition
* Known immunodeficiencies
* Usage of antibiotics or probiotics within the previous month
* Known renal calculi or anatomic malformations

Control subjects- Inclusion criteria:

* Menopausal status
* Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay

Control subjects- Exclusion criteria:

- A prior history of UTIs or other urologic abnormalities.

Primary outcomes:
measure: Characterization of the microbiome using molecular methods.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Ahinoam Lev-Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References: