louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00953316: Infant Transition From Car Bed to Car Safety Seat
Official title: A Prospective Examination of Infant Transition From Car Bed to Car Safety Seat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Car Seat Transition for At-risk Infants
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 96
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At-risk infants, including all children born at less than 37 weeks gestation and other high risk newborns such as those with a history of breathing problems and/or low tone.

Brief summary: This research study has been developed to obtain preliminary information about safe timing of the transition of infants from car beds to car seats, and to find out if initial failure of the car seat challenge is associated with small jaw size or increased respiratory illness.

Detailed description: Studies show that car seats can directly reduce injury in motor vehicle accidents. Unfortunately, some premature and term infants have trouble breathing from the semi-upright seating position in car seats. As a result, the American Academy of Pediatrics recommends car seat challenge testing for at-risk infants, including all children born at less than 37 weeks gestation and other high risk newborns such as those with a history of breathing problems and/or low tone. Infants who fail the car seat test are discharged home in car beds. However, guidelines regarding timing of repeat car seat testing or safe transition back to a car seat are currently unavailable.

At present there is no system for continued evaluation of infants sent home in car beds. In addition, it is not known when it is safe to transition infants from their car bed to a car seat. Infants transitioned too early may still have breathing problems and those transitioned too late may be at risk for injury in the event of a crash. Due to these reasons it is important to find out when it is safe to transition infants from the car bed to a car seat

Moreover, it has recently been shown that some infants with apparent life threatening events (ALTE), have a smaller jaw size than their peers that did not have an ALTE. ALTEs can occur when infants are in their car seats. No studies have been found that looked to see if infants with breathing problems in their car seats also have small jaws. Furthermore no studies have looked to see if infants who fail their initial car seat challenge are at greater risk for respiratory illness during their first year of life.

Eligibility criteria: Inclusion Criteria:

* All infants who visit Children's Hospital Boston, Center for Healthy Infant Lung Development for follow up car seat testing

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hosptital, Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT00716196: A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)
Official title: A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During EUS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suspected Malignant Lesions
Keywords: thin prep
EUS
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-07-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample from patients presenting at the GI endoscopy unit for an EUS.

Brief summary: Objective: The purpose of this study was to compare the performance of the monolayer preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis of specimens obtained using EUS-FNA.

Detailed description: Introduction: The presence of a pathologist during an endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is often a luxury. In addition, preparation of multiple slides for a fine needle aspiration can be time-consuming for the gastroenterologist who waits for verbal feedback on the adequacy of the specimen. Often, a timely diagnosis is needed to direct patient management. Currently, there is no established standard of care for EUS-FNA preparation. A liquid based cytologic fixative preparation (Thin-prep or CytoLyt), is a well-established process used by pathologists for evaluating cervical smears. It has not yet been adopted or accepted for EUS-FNA. This method combines multiple aspirates on a single slide, thereby decreasing the number of slides that need to be processed and interpreted by the pathologist

Eligibility criteria: Inclusion Criteria:

* Subjects with known or suspected malignancy (solid mass or lymph node) that are undergoing EUS will be eligible to participate in this study.
* Target lesions such as ascites and cystic lesions will not be considered for this study. However, if a patient has an abnormal solid lesion and abnormal lymph node in addition to the ascites or cystic lesion, they may still be considered for the study. That is, the solid lesions and abnormal lymph nodes are appropriate target lesions for this study.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Subject must provide signed written informed consent.

Exclusion Criteria:

* Subjects that have had a previous EUS-FNA are eligible for this study
* Target lesions such as ascites and cystic lesions will not be considered for this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian/Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Julia K LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709796: The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
Official title: The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IVF
Embryo Loss
Miscarriage, Recurrent
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.


Eligibility criteria: Inclusion Criteria:

* The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage.

Furthermore, other specific 'RIF' investigations were performed and treated if necessary:

* Normal hysteroscopy
* Normal karyotype of both parents
* Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation)
* Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)

Exclusion Criteria:

* • Simultaneous participation in another clinical study

  * Untreated and uncontrolled thyroid dysfunction
  * Tumors of the ovary, breast, uterus, pituitary or hypothalamus
  * Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
  * Ovarian cysts or enlarged ovaries
  * Malformations of the reproductive organs
  * Moderate or severe hepatic impairment
  * Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
  * Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
  * Couples needing TESE/MESA material

Primary outcomes:
measure: Live birth
timeFrame: 9 months after embryo transfer
Secondary outcomes:
measure: positive hCG
timeFrame: 11 days (± 2 days) after embryo transfer.
measure: ongoing pregnancy rate
timeFrame: between 6 and 8 weeks of gestation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Dominic Stoop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062996: Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption
Official title: The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dental Anesthesia
Nasal Surgical Procedures
Intranasal Drug Administration
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.


Eligibility criteria: Inclusion Criteria:

* Patients ages 2 through 12 yrs.
* Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).

Exclusion Criteria:

* Treatment with oral decongestants or antihistamines within 24 hours of surgery.
* Taking anticoagulants.
* History of nasal trauma.
* History of epistaxis (nose bleeds).
* History of hypertension or cardiac disease.
* Allergy to oxymetazoline.

Primary outcomes:
measure: Oxymetazoline plasma concentration
timeFrame: 5, 10, 20, 45, 90 & 150 mins. after dosing
Secondary outcomes:
measure: Heart rate
timeFrame: Every 2-5 mins. for a maximum of 240 mins.
measure: Blood pressure
timeFrame: Every 2-5 mins. for a maximum of 240 mins.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Richard Cartabuke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839096: Once Versus Twice Daily Iron Supplementation in Pregnant Women
Official title: Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anemia in Pregnancy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

Detailed description: Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO twice daily.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation
* Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
* In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
* In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.

Exclusion Criteria:

* Multiple gestation
* Maternal hemoglobinopathy or hemochromatosis,
* Irritable bowel disease or irritable bowel syndrome
* History of bariatric surgery or extensive bowel surgery
* Individuals already receiving iron supplementation aside from prenatal vitamins.

Primary outcomes:
measure: Hemoglobin
timeFrame: Change in hemoglobin from baseline to one day postpartum
measure: Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
timeFrame: From enrollment to delivery, which will be an average of 10-12 weeks
Secondary outcomes:
measure: Incidence of Blood Transfusion at Delivery
timeFrame: At delivery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Mistie P Mills, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04557696: A Study to Implement and Evaluate REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
Official title: Implementation and Prospective Evaluation of the REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medical Trainees in Oncology Programs
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. The information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.


Eligibility criteria: Inclusion Criteria:

* Subjects: Resident or Fellow enrolled in an oncology related training program (Radiation Oncology, Medical Oncology, Palliative Medicine and Hospice Care, Neurooncology).
* Location: Mayo Clinic Arizona.
* Interest: Willingness to participate.

Exclusion Criteria:

* Schedule does not permit to participation.
* Not enrolled in an oncology-based residency or fellowship at Mayo Clinic Arizona.
* Interest: Not willing to participate.

Primary outcomes:
measure: Emotional Intelligence
timeFrame: Baseline, annually through study completion approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Tamara Vern-Gross, DO, FAAP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01406496: Best Timing of Insulin Bolus Before Meals of Different Contents
Official title: The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Insulin bolus
glucose excursions
post-prandial
timing
meal content
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-meal glucose excursions may contribute to the development of diabetes-related complications. These glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin bolus (by pump) is controversial.

The aim of the study is to examine three different timings of insulin bolus in three types of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat. The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system. The results obtained in the diabetic patients will be compared to those obtained in a group of healthy individuals that will consume similar meals.


Eligibility criteria: Inclusion Criteria:

Diabetes patients:

* Type 1 diabetes
* Age 8 to 20 years
* Both genders

Control group:

* Age 18 to 30 years
* Both genders

Exclusion Criteria:

Diabetes patients:

* Less than a year from the diagnosis of type 1 diabetes
* Less than 6 months from the time of insulin pump introduction

Control group:

* Pregnancy
* Any diagnosed or suspected chronic diseases
* Current or recent (within 1 month) use of drugs (not including oral contraceptives and inhaled steroids for asthma).

Primary outcomes:
measure: Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
timeFrame: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Pediatric Endocrinology Unit, Kaplan Medical Center
Study officials:
affiliation: Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
name: Amnon Zung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04111796: Nature-based Solutions for Work-related Stress
Official title: Nature-based Solutions for Work-related Stress: an Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. The investigators aim to conduct a randomised controlled pilot study.

During workhours one group participates in a nature-based program, the other group is a control group. The investigators test stress-related parameters including cortisol levels, wellbeing and stress, and neurocognition.

Detailed description: Participants of the intervention group follow a 30-minute stress management course in nature followed by a nature-based activity of 1.5 hours, twice a week for 3 consecutive weeks. The investigators measure neurocognition via neurocognitive tests, emotional status via burnout assessment tool and well-being questionnaires, and asses stress levels via salivary cortisol and smartwatches.

Eligibility criteria: Inclusion Criteria:

* work at province of Limburg speak dutch

Exclusion Criteria:

-

Primary outcomes:
measure: Neurocognition: selective attention
timeFrame: 5 minutes
measure: Neurocognition: short-term memory
timeFrame: 10 minutes
measure: Neurocognition:visual information processing speed
timeFrame: 5 minutes
measure: Neurocognition: visual information processing speed
timeFrame: 5 minutes
measure: stress levels
timeFrame: 5 minutes
measure: stress levels
timeFrame: 10 minutes
measure: stress levels
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Province of Limburg
state: Limburg
Study officials:
affiliation: Hasselt University
name: Michelle Plusquin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daniels S, Clemente DBP, Desart S, Saenen N, Sleurs H, Nawrot TS, Malina R, Plusquin M. Introducing nature at the work floor: A nature-based intervention to reduce stress and improve cognitive performance. Int J Hyg Environ Health. 2022 Mar;240:113884. doi: 10.1016/j.ijheh.2021.113884. Epub 2021 Nov 27.