louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02275507: Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery
Official title: Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications of Pregnancy, Childbirth and the Puerperium
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who are scheduled for an elective repeat or primary cesarean delivery. We will exclude women at high-risk for hemorrhage, thalassemia major, sickle cell disease, or women with hypertensive disorders

Brief summary: The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.

Detailed description: Acute and life threatening blood loss is the most common cause of morbidity and mortality for pregnancy women in the US. To date, the only means we have of monitoring the amount of blood loss during a delivery is by the physician estimating the amount. This has been shown to not be very accurate and leads to confusion on when and how much a women should be transfused during a hemorrhage. New devices have been developed over the last few years to monitor blood levels in a accurate and non-invasive fashion. We aim here to use a non-invasive blood monitoring system to evaluate normal blood loss in women undergoing scheduled cesarean delivery. We hope that this will allow us to create a baseline that can be used in subsequent studies to identify women who are losing more blood than normal so that we may intervene faster and avoid unnecessary morbidity.

Eligibility criteria: Inclusion Criteria:

* Women undergoing scheduled cesarean delivery

Exclusion Criteria:

* Blood disorders (i.e. thalassemia, sickle cell), hypertensive disorders, obstetric risk factors for hemorrhage

Primary outcomes:
measure: Decrease in Hemoglobin over time
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University Hospital
name: Joseph Chappelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.
citation: Butwick A, Hilton G, Carvalho B. Non-invasive haemoglobin measurement in patients undergoing elective Caesarean section. Br J Anaesth. 2012 Feb;108(2):271-7. doi: 10.1093/bja/aer373. Epub 2011 Nov 23.
Clinical trial NCT03475407: The Effects of Intravitreal Ozurdex Implant in DME
Official title: The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
cytokine
dexamethasone
Lead sponsor: Nune Eye Hospital, Seoul, Korea
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.


Eligibility criteria: Inclusion Criteria:

The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

* Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
* Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
* Diabetic patients with cystoids macular edema
* Minimum central thickness on OCT not less than 300 microns
* BCVA 20/30\~20/320

Exclusion Criteria:

* Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
* Patients with history of ocular hypertension or glaucoma
* Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
* Patients with macular ischemia on FFA
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
* Patients whose posterior lens capsule is not intact.
* patients with known hypersensitivity to any components of this product.
* patients with vitreous hemorrhage
* patients who have systemic treatment effect on study results
* patients who enrolled other clinical study

Primary outcomes:
measure: Changes of Central foveal thickness(CFT, height in micrometers)
timeFrame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary outcomes:
measure: Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)
timeFrame: Baseline, 6 weeks, 18 weeks
measure: Changes of Best corrected Visual acuity(BCVA, ETDRS scale)
timeFrame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital
Study officials:
affiliation: Nune Eye Hospital
name: Oh Woong Kwon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04009707: Comparison of 2 Tests to Diagnose Cognitive Dysfunctions in Alcohol Disease
Official title: Comparison of 2 Tests for Screening for Cognitive Disorders (MoCA / BEARNI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorder
Keywords: MoCA
BEARNI
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with alcoo use desorder

Brief summary: The objective of this study is therefore to compare the results obtained with these two screening tests, using as gold standard the results obtained by the battery of neuropsychological reference tests.

Detailed description: Recently, a new screening test for cognitive disorders was specifically developed for patients with UAS: BEARNI (Brief Evaluation of Alcohol-Related Neuropsychological Impairments). Since the BEARNI is presented as the reference test, the investigators have systematically proposed it to hospitalized patients, in combination with the usual check-up. In practice, at admission, patients were therefore given two screening tests, the MoCA and the BEARNI. In the event of an anomaly in at least one of these tests, a battery of confirmatory neuropsychological tests was performed.

Eligibility criteria: Inclusion Criteria:

* patients with alcoo use desorder
* Patient cared for in the addictology department of the University Hospital of Nîmes

Exclusion Criteria:

* refusal to use the data

Primary outcomes:
measure: sensitivity
timeFrame: Day 1 (only 1 time)
measure: specificity
timeFrame: Day 1 (only 1 time)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
References:
Clinical trial NCT02146807: Laser Treatment of Tattoos With Pico Laser
Official title: LASER TREATMENT OF TATTOOS WITH A DUAL WAVELENGTH PICOSECOND LASER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unwanted Tattoos
Keywords: Tattoos, Picosecond Laser, Syneron
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.

Detailed description: The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

A multicenter study.

Eligibility criteria: Inclusion Criteria:

1. Has Fitzpatrick skin type I-IV
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them
3. Is willing to consent to participate in the study
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure
2. Has an active sun tan
3. Has Fitzpatrick skin type V or VI
4. Has active localized or systemic infection
5. Is taking medication(s) for which sunlight is a contraindication
6. Has a history of squamous cell carcinoma or melanoma
7. Has a history of keloid scarring
8. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
9. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
10. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period
11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine

Primary outcomes:
measure: Global percentage of tattoo clearance
timeFrame: 3 months post the final treatment
Secondary outcomes:
measure: Rate of tattoo clearance
timeFrame: 3 months
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 3 months
Locations:
city: Washington
country: United States
facility: Washington Institute of Dermatologic Laser Surgery
state: District of Columbia
city: New York
country: United States
facility: New York Laser and Skin Care
state: New York
city: Ardmore
country: United States
facility: Main Line Center for Laser Surgery
state: Pennsylvania
Study officials:
affiliation: Syneron Medical Ltd.
name: Shlomit Mann
role: STUDY_DIRECTOR
References:
Clinical trial NCT04011007: Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Official title: Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Retina Detachment
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 40
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: The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling.

This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery.

Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery.

Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.


Eligibility criteria: Inclusion Criteria: macular hole retinal detachment in high myopic eyes.

-

Exclusion Criteria:

* eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.

Primary outcomes:
measure: visual acuity at one year
timeFrame: 12 months
Secondary outcomes:
measure: rate of retinal attachment and macular hole closure.
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT01442207: Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
Official title: Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Premature Birth
Placenta Previa
Keywords: Premature Birth
Placenta Previa
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.

Detailed description: The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy, ≥ 18yrs old
* GA 18w0d to 26w0d inclusive @ time of enrollment
* Documentation of complete placenta previa (≥ 10mm over internal os)
* Agrees to participate in trial and signs/date an informed consent form.

Exclusion Criteria:

* Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
* Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
* Known uterine anomaly at time of enrollment
* History of two or more prior cesarean deliveries
* Suspected placenta accrete, increta or percreta on US at enrollment
* Cervical cerclage present at time of enrollment

Primary outcomes:
measure: Gestational age (GA) at birth
timeFrame: measure taken in the first 23 hours after birth.
Secondary outcomes:
measure: Newborn Birth weight
timeFrame: measured within 1-2 days after birth
measure: Need for Maternal Blood Product replacement
timeFrame: measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)
measure: Number of participants delivering prematurely following hemorrhage who have a positive fFN test.
timeFrame: measured at delivery
Other outcomes:
Locations:
Study officials:
affiliation: Obstetrix Medical Group of Tucson.
name: Irene Stafford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998007: Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Official title: Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: PainQx, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty (50) male and female pain patients with symptoms in excess of 3 months duration (per the IASP definition of Chronic Pain) between the ages of 18-85 years were enrolled. Subjects who met the inclusion/exclusion criteria were asked to volunteer for the study.

Brief summary: Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.


Eligibility criteria: Inclusion Criteria:

* Male and female chronic pain patients
* Patients between the ages of 18-85 years
* Patients exhibiting the presence of symptoms in excess of 3 months duration
* Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
* Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)
* Patients with NRS pain scores across the full range (1-10) at the time of testing

Exclusion Criteria:

* Patients with medically diagnosed psychotic illness
* Patients with medically diagnosed drug or alcohol dependence in the past 12 months
* Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
* Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
* Patients who have a spinal cord stimulator, or other implantable devices
* Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain
* Patients with cancer
* Patients on workers compensation or disability
* Patient on anticonvulsant medication
* Patients who have a history of seizures

Primary outcomes:
measure: Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Pain Care Center
state: Massachusetts
Study officials:
affiliation: PainQx, Inc
name: William Koppes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519307: Evaluation of Newborns Presenting With Suspected COVID 19
Official title: Evaluation of Newborns Presenting With Suspected COVID 19: A Single Center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Infection
Keywords: newborn
covid infection
viral infection
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 72
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newborns who had respiratory symptoms at the NICU admission

Brief summary: This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission


Eligibility criteria: Inclusion Criteria:

* All newborns who had respiratory symptoms at the NICU admission

Exclusion Criteria:

* Congenital abnormalities

Primary outcomes:
measure: General Characteristics of the infants with respiratory infection at the NICU admission
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Dr. Behcet Uz Training and Research Hospital
Study officials:
References:
Clinical trial NCT01078207: Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
Official title: A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.

Brief summary: This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

Detailed description: There is no further detailed description available.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
* Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study
* Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs.
* Patients in the ASA category 1-4
* Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.)
* Spontaneous breathing

Exclusion Criteria:

* Age less than 18 years
* Patients receiving or anticipated to receive postoperative positive airway pressure support
* Previous allergic/contact reactions to adhesives
* Patients unable to give informed consent
* Pregnancy

Primary outcomes:
measure: Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.
timeFrame: 12 hour after released from the recovery room
Secondary outcomes:
measure: Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.
timeFrame: 12 hours after discharge form the recovery room
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Medtronic - MITG
name: Roger Mecca, MD
role: STUDY_CHAIR
References: