louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01444768: Prospective Evaluation of Computerized Physician Order Entry in the Emergency Department
Official title: Prospective Evaluation of Computerized Physician Order Entry in the Emergency Department
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Operational Metrics of the Emergency Department
Keywords: Alert Systems, Medication
Computerized Physician Order Entry System
CPOE
Medication Alert Systems
Medical Order Entry Systems
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 0
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: All patients who are registered in the emergency department \> 18 years of age who do not elope, left without being seen, or leave AMA.

Brief summary: This study will evaluate various performance metrics of emergency department operations after the implementation of computerized physician order entry in an academic emergency department.

Detailed description: The study will be a prospective before-after study comparing various operational and performance metrics before and after the implementation of a computerized physician order entry system in the emergency department.

The investigators will collect 6 month before, 6 month after of data along with a 2-4 week washout period. The investigators will also administer a computerized physician order entry survey after the study is completed. This confidential survey will be emailed to all ED nurses, residents, and attendings using RedCap. Consent will be implied if they choose to participate.

Eligibility criteria: Inclusion Criteria:

* All consecutive adult patients (Age \>=18) presenting to the Emergency Department during the study period will be included in the study.

Exclusion Criteria:

* Patients who eloped, left without being seen, or signed out against medical advice will be excluded.

Primary outcomes:
measure: Time to Antibiotics
timeFrame: 6 months
Secondary outcomes:
measure: Emergency Department Length of Stay
timeFrame: 6 months
measure: Lab turnaround time
timeFrame: 6 months
measure: Resource Utilization
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Steven Horng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03871868: Vitamin D Levels And Myoma Uteri
Official title: Vitamin D Levels İn Women With and Without Myoma Uteri
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma;Uterus
Vitamin D Deficiency
Polycystic Ovary
Keywords: 25-hydroxyvitamin D
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The reproductive age women (25-50 years) with at least one 10 mm or larger diameter leiomyoma detected by transvaginal ultrasound were the study group.

Brief summary: Women with at least one uterine leiomyoma and polycystic ovary syndrome over 10 mm and women with normal ultrasonographic findings were included in the study. Blood samples were taken for biochemical analysis such as vitamin D, calcium, magnesium, phosphorus, thyroid stimulating hormone (TSH), hemoglobin (hb), hematocrit (htc), platelet (plt), and albumin. The study groups were compared in terms of these biochemical markers and family history of patients, daily sunshine hours, clothing preferences and education level.


Eligibility criteria: Inclusion Criteria: The reproductive age women (25-50 years) with at least one 10 mm or larger diameter leiomyoma detected by transvaginal ultrasound were the study group.

Exclusion Criteria:

* Patients with a history of myomectomy,
* chronic systemic disease
* malignancy
* history of adenomyosis
* women in menopause
* pregnant women
* vitamin D supplementation
* lactation
* abortion and pregnancy loss in the last 6 months
* oral contraceptive / hormonal agents in the last 3 months

Primary outcomes:
measure: Vitamin D levels
timeFrame: december 2018- march 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00929968: Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
Official title: A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis,
atopic patients,
seasonal allergy,
ragweed allergy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between ages of 18 to 60 in good health
* History of atopy for at least 2 years and positive skin prick test to ragweed allergen

Exclusion criteria:

* History of asthma treated with corticosteroids
* Smokers with a smoking history of \> 10 pack/years or smoking in the past year
* History of chronic obstructive pulmonary disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
timeFrame: 12 weeks
measure: Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
timeFrame: 12 weeks
measure: Immunogenicity of multiple intravenous doses of VAK694
timeFrame: 12 weeks
measure: Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.
timeFrame: 12 weeks
measure: Changes in biomarkers of immunomodulation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05193968: Hot Flashes and Neurovascular Function in Women
Official title: Hot Flashes and Neurovascular Function in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hot Flashes
Menopause
Vasomotor System; Labile
Keywords: Neurovascular function
Autonomic function
Microvascular Function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.


Eligibility criteria: Inclusion Criteria:

* Non-smokers.
* Non-obese.
* Have at least one ovary.
* Free from cardiovascular disease.
* Not taking medications influencing cardiovascular function.

Exclusion Criteria:

- None.

Primary outcomes:
measure: Compare microvascular function in women with low and high frequency hot flashes
timeFrame: Continuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)
measure: Compare sympathetic function in women with low and high frequency hot flashes
timeFrame: Continuous measurement of muscle sympathetic nerve activity at rest and in response to stressors (~75min of continuous data collection once a sympathetic nerve signal is found)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sarah Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03762668: Performance Assessment of a Modified Daily Disposable Contact Lens
Official title: Performance Assessment of a Modified Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Hyperopia
Keywords: Contact lens
Vision correction
Visual acuity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Detailed description: The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
* Monocular (only one eye with functional vision);
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: High Contrast Distance Visual Acuity (logMAR)
timeFrame: Day 1 Dispense, Day 7 Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Alcon Investigative Site
state: Florida
city: Ann Arbor
country: United States
facility: Alcon Investigative Site
state: Michigan
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research
name: Sr. CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05513768: PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs
Official title: Can First Trimester Serum Myocine Binding Protein c Level Predict Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm
Keywords: PRETERM DELİVERY, MBPC,
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Includes participants whose serum samples were collected in the first trimester, stored, and then divided into two according to timing of delivery fırst grup ıs preterm group, and second one ıs those who gave birth on time

Brief summary: IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.

SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.

Detailed description: IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.

SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.A TOTAL OF 90 WOMEN WERE PLANNED TO INCLUDE 45 STUDY 45 CONTROL GROUP IN THE STUDY.

Eligibility criteria: Inclusion Criteria:

* being pregnant in the first trimester
* be between 18-40 years old

Exclusion Criteria:

* no history of preterm birth
* being pregnant with assisted reproductive techniques
* having a multiple pregnancy
* have cervical insufficiency

Primary outcomes:
measure: detection of prediction value of serum mbpc levels in preterm delivery
timeFrame: 10 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
state: Gaziosmanpaşa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: elif yıldız
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663868: Single-center Prospective Cumulus Cell Test Study in rFSH Patients
Official title: Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 100
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients


Eligibility criteria: Inclusion Criteria:

* scheduled for intracytoplasmatic sperm injection (ICSI) and single (or double) embryo transfer on day 3
* patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH)
* undergoing first or second IVF or ICSI cycle with transfer
* Body Mass Index (BMI) between 17 and 33
* regular menstrual cycle (between 24 and 35 days)

Exclusion Criteria:

* smokers (\> 10 cigarettes per day)
* patients requesting Pre-implantation Genetic Diagnosis (PGD)
* patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
* couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (\< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
* results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect

Primary outcomes:
measure: Clinical pregnancy as observed by ultrasound
timeFrame: 2 months after embryo transfer
Secondary outcomes:
measure: Positive beta-hCG pregnancy as observed by serum analysis
timeFrame: 12-17 days after embryo transfer
measure: Live birth by questionnaire
timeFrame: at least 9 months after embryo transfer
measure: Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)
timeFrame: 2 years after embryo transfer
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Johan Smitz, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03598868: Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Official title: Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bipolar Disorder Depression
Keywords: Bipolar Disorder
Depression, Bipolar
vortioxetine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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 validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.

Detailed description: In this study, the investigators are going to examine the efficacy of vortioxetine augmentation in bipolar disorder patients with depressive symptoms.

The study design is a double-blinded 6-week prospective study. It would be useful for clinicians because it will provide new evidence for the effect of vortioxetine in bipolar disorder patients with depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Unspecified Bipolar and Related Disorder by Diagnostic and Statistical Manual (DSM)-V criteria.
* 18 to 65 years of age
* Patients with Montgomery-Åsberg Depression Rating Scale score ≥ 23 (moderate to severe depression), after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
* Patients with Young Mania Rating Scale score lower than 10, after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics

Exclusion Criteria:

* Currently experiencing manic, hypomanic, or mixed episode
* Comorbid with serious medical illness
* Comorbid with substance use disorder, medical illness or other neurologic disorder that may have caused depressive symptoms other than by bipolar disorder
* Pregnancy or Breastfeeding women
* Those who are hypersensitive to the main or other ingredient of the medication
* Currently on Monoamine oxidase (MAO) inhibitor or those who have discontinued MAO inhibitor in the last 14 days
* Severe liver disease, severe renal disease
* Bleeding tendency/disorder

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical Global Impressions (CGI) scale
timeFrame: 6 weeks
measure: Digit Symbol Substitution Test (DSST)
timeFrame: 6 weeks
measure: Medication diary
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03854968: Quality Control of Home Mechanical Ventilators
Official title: Quality Control Of Home Mechanical Ventilated Patient Mechanical Ventilators. A Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Mechanical ventilation
Performance
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Home mechanically ventilated
* \>18 years

Exclusion Criteria:

* Pacients with servoventilation

Primary outcomes:
measure: Pressure
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic
name: Josep M Montserrat, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661268: The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock
Official title: The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Chengdu Fifth People's Hospital
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.
Primary purpose: TREATMENT

Brief summary: Fluid challenge is often carried out in septic shock patients. Its responsiveness usually requires invasive monitoring. The pulmonary artery catheter(PAC) is the most effective means of monitoring.To use non-invasive methods is very tempting. Investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and Central Venous SO2 variations provides feasible estimation on fluid responsiveness in septic shock patients.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old; less than 75 years old ICU patients
* Septic shock
* Monitored with pulmonary artery catheter (Swan-Ganz catheter)
* The decision of fluid challenge made by the treating physician

Exclusion Criteria:

* Evidence of fluid overload
* Pregnancy
* Recently participated in other studies
* Severe heart failure

Primary outcomes:
measure: cardiac index change
timeFrame: Immediately after fluid challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: ICU of Chengdu Fifth People's Hospital
state: Sichuan
Study officials:
affiliation: Chengdu Fifth People's Hospital
name: wang ping, MD
role: STUDY_CHAIR
References: