louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06683469: Neutrophil-to-Lymphocyte Ratio in Predicting Outcomes of Patients With Aneurysmal Subarachnoid Hemorrhage in a Tertiary Care Hospital in Nepal
Official title: Neutrophil-to-Lymphocyte Ratio in Predicting Outcomes of Patients With Aneurysmal Subarachnoid Hemorrhage in a Tertiary Care Hospital in Nepal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SAH (Subarachnoid Hemorrhage)
Lead sponsor: Maharajgunj Medical Campus
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 years of age, of either genders, ethnicity and location who presented to the emergency department within 72 hours of the onset of symptoms who underwent surgical or interventional treatment for SAH caused by a ruptured intracranial aneurysm

Brief summary: This study uses Neutrophil-to-Lymphocyte Ratio to Predict Outcomes of Patients with Aneurysmal Subarachnoid Hemorrhage which will be beneficial in taking early decisions for surgery , patient counselling etc


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age, of either genders, ethnicity and location who presented to the emergency department within 72 hours of the onset of symptoms who underwent surgical or interventional treatment for SAH caused by a ruptured intracranial aneurysm

Exclusion Criteria:

* excluded patients with traumatic SAH, history of infection or stroke within eight weeks, underlying cancer, severe kidney or liver disease, history of auto-immune or hematologic disorder lost to follow-up within three months and individuals declining informed consent.

Primary outcomes:
measure: mRS score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
Study officials:
References:
citation: Guo Y, Liu J, Zeng H, Cai L, Wang T, Wu X, Yu K, Zheng Y, Chen H, Peng Y, Yu X, Yan F, Cao S, Chen G. Neutrophil to lymphocyte ratio predicting poor outcome after aneurysmal subarachnoid hemorrhage: A retrospective study and updated meta-analysis. Front Immunol. 2022 Aug 9;13:962760. doi: 10.3389/fimmu.2022.962760. eCollection 2022.
Clinical trial NCT02884869: Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway
Official title: Establishing a Definitive Airway: Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Blind intubation,
Laryngeal Mask Airway
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners.

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.

Detailed description: Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The Laryngeal Mask Airway and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.The aim of this study is to examine the effectiveness of the Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model)

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiology class I and II

Exclusion Criteria:

* Difficult airway
* Cervical pathology
* Full stomach

Primary outcomes:
measure: Time of blind intubation measure in second
timeFrame: 30 seconds
Secondary outcomes:
measure: Easy to perform intubation measure in numeric scale
timeFrame: 30 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion Medical Center
name: Luis A Gaitini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05135169: Multi-organ Transit Time Acquisition Using Contrast Ultrasound
Official title: Multi-organ Transit Time Acquisition Using Contrast Ultrasound
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-section of VHVI faculty and sonographers

Brief summary: Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* able to give informed consent

Exclusion Criteria:

1. Known allergic reaction to Definity ultrasound contrast
2. Pregnancy/Nursing - as assessed/disclosed by the participant

Primary outcomes:
measure: transit time
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: VUMC
state: Tennessee
Study officials:
References:
Clinical trial NCT05985668: Towards Improved Diagnostics for Suspected Platelet Function Disorders
Official title: Towards Improved Diagnostics for Suspected Platelet Function Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Platelet Function Disorder
Platelet Disorder
Thrombocytopathy
Keywords: diagnostic accuracy
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-08-14
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited at Karolinska University Hospital

Brief summary: This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.


Eligibility criteria: Inclusion Criteria, known defects:

* Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay)
* High likelihood of platelet function disorder (aberrant screening test with inheritance)
* Family investigation for platelet disorder

Exclusion Criteria, known defects::

* Antiplatelet or anticoagulant drugs
* vWF:GPIb below 0.40 IU/mL
* Hematocrit below 0.35 or above 0.50
* Other coagulation disorder

Inclusion Criteria, suspected platelet function disorder:

* Bleeding investigation at Karolinska University Hospital

Exclusion Criteria, suspected platelet function disorder::

* Antiplatelet or anticoagulant drugs
* vWF:GPIb below 0.40 IU/mL
* Hematocrit below 0.35 or above 0.50
* Other coagulation disorder

Primary outcomes:
measure: Platelet-thrombus formation on collagen surface
timeFrame: At study inclusion
Secondary outcomes:
Other outcomes:
measure: Platelet count effect on platelet-thrombus formation on collagen surface
timeFrame: At study inclusion
measure: ddAVP effect on platelet-thrombus formation on collagen surface
timeFrame: Immediately before and 1 hour after administration of ddAVP.
measure: Thrombus formation on collagen/TF
timeFrame: At study inclusion
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT03238768: Enhanced Nutrition for Preterm Infants
Official title: Enhanced Early Nutrition for Preterm Infants to Improve Neurodevelopment and Minimize Metabolic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Nutrition
Body Composition
Preterm
Neonate
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 80
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be randomized to receive either standard parenteral nutrition via the NICU protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of the proposal is to demonstrate the feasibility of providing increased calories and protein in the first week of life to very low birth weight (VLBW) preterm infants.

Detailed description: Infants will be randomized to receive either standard parenteral nutrition via the neonatal intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.

Eligibility criteria: Inclusion Criteria:

* VLBW (birth weight \<1500grams) preterm (gestational age (GA) at birth \< 32 weeks) infants admitted to the University of Minnesota Masonic Children's Hospital NICU, for which written informed consent can be secured from a parent within 12 hours of birth.

Exclusion Criteria:

* Infants who are diagnosed prenatally with a clinical condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development, who experienced severe birth asphyxia, who are enrolled in another study affecting nutritional management, or who are likely to be transferred out of the NICU will be excluded from participation.

Primary outcomes:
measure: The primary outcome measure will be the amount of nutrition ( kcals/kg/day and amount of protein g/kg/day and amount of lipids g/kg/day) received in the first week of life.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Children's Hospital
name: Sara E Ramel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03303768: Antenatal Diagnosis of Coarctations of the Aorta.
Official title: Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coarctation of Aorta
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 20
Sex: FEMALE
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: Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy.

Brief summary: Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.


Eligibility criteria: Inclusion Criteria:

* pregnant or having given birth in the last 12 months in one of the participating centers
* have had an ultrasound screening in the 2nd or 3rd trimester
* addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the aegis of the left ventricle or the large vessels at the aorta, discovered during a screening ultrasound second or third quarter.
* be able to understand and follow the ins and outs of the study
* Have been informed of the study and have not objected to it

Exclusion Criteria:

* Associated complex cardiac disease (transposition of large vessels, atrioventricular duct, right ventricle with double outlet) with the exception of inter ventricular communications
* Left ventricular hypoplasia
* Suspicion of interruption of the aortic arch

Primary outcomes:
measure: Search for ultrasound risk factors associated with diagnosis coarctation of the aorta
timeFrame: 24h after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant
Study officials:
References:
Clinical trial NCT06512168: Measuring Aided Language Development
Official title: Measuring Aided Language Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Cerebral Palsy
Apraxia of Speech
Speech Sound Disorder
Speech Disorders in Children
Speech and Language Disorder
Keywords: Augmentative and Alternative Communication
Complex Communication Needs
Assistive Technology
AAC
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of New Mexico
name: University of Wisconsin, Milwaukee
First posted: 2024-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 42
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \& Kent-Walsh).

Detailed description: Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.

Eligibility criteria: Inclusion Criteria:

* Clinical Identification of Down Syndrome or Cerebral Palsy + Significant Speech Impairment
* Must Speak English as a Primary Language
* Must Be Able to Express At Least 25 Words (using any communication mode)
* Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy
* Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities

Exclusion Criteria:

* Clinical Diagnosis of Autism or Social Communication Disorder
* Primary Language Spoken is A Language Other than English

Primary outcomes:
measure: Aided AAC Utterance Length
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida - Innovative Center
state: Florida
Study officials:
References:
Clinical trial NCT00703768: Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
Official title: An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Quality of Life
Androgen Deprivation Therapy
Goserelin
Lead sponsor: Urology South Shore Research Inc.
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-06-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male subjects aged 18 years or older with histologically-confirmed prostate cancer, showing biochemical failure (defined as a rising PSA) following definitive therapy (surgery or radiation) and indicated to receive hormone therapy.

Brief summary: The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Received therapy of curative intent (surgery or radiotherapy)
* Have a rising PSA which has doubled from a nadir value.
* Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months
* Written informed consent to participate in the trial.

Exclusion Criteria:

* Known hypersensitivity to Zoladex, Casodex, ar any component of these products
* Prior treatment with LHRH agonist or anti-androgens in the past 12 months
* Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.

Primary outcomes:
measure: Significant difference in FACT-P scores after 12 months between the 2 groups
timeFrame: 12 months
Secondary outcomes:
measure: PSA response
timeFrame: 12 months
measure: To evaluate the ease of use of FACT-P to measure Quality of Life
timeFrame: 12 months
measure: QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
facility: Urology South Shore Research Inc.
state: Quebec
Study officials:
name: Lorne Aaron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01863368: Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Official title: Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry eye syndrome
Systane Ultra
Optive
Ocular Surface Staining
OSDI
Eye drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 105
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 purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Detailed description: Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Eligibility criteria: Inclusion Criteria:

* Willing and able to attend all study visits.
* Diagnosis of dry eye, as specified in protocol.
* Uses artificial tears, as specified in protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Poor visual acuity, as specified in protocol.
* Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
* Any hypersensitivity or allergy to the investigational products or ingredients.
* Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
* Contact lens use within 2 weeks of Screening Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
timeFrame: Baseline, Day 35
Secondary outcomes:
measure: Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
timeFrame: Day 35
measure: Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
timeFrame: Day 35
measure: Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
timeFrame: Day 35
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Steve Burmaster
role: STUDY_DIRECTOR
References:
citation: Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.