louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02068989: Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus
Official title: Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Hyperglycemia
Diabetes Mellitus Type 2
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care Unit admissions who are not known to be diabetic

Brief summary: We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital

Exclusion Criteria:

* Patients with prior history of diabetes mellitus
* Elevated admission HbA1c (≥6.5%)
* Age \>80 years
* Metastatic disease with expected life expectancy of less than 12 months
* Pregnancy or a woman who plans to become pregnant

Primary outcomes:
measure: Percentage of Subjects with an HbA1c greater than or equal to 6.5%
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital St. Raphael Campus
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
Study officials:
affiliation: Yale New Haven Hospital
name: Stephen Atlas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwalk Hospital
name: Jonathon Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720989: Cleanser Versus Only Water
Official title: The Effect of Cleansing Product Used in the First Bathing on Transepidermal Water Loss and Skin Ph in Late Preterm and Term Infants: A Multicenter, Evaluative Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Skin Barrier Function
First Bathing
Baby Cleanser
Transepidermal Water Loss
Skin pH
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 34
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.

Detailed description: Studies in the literature on the effects of newborn bath types on the effects of body temperature on newborn crying times, on the effects of newborn behavior and stress, the views and practices of mothers with newborn babies on baby bathing, and the effects of bath types on the umbilical cord in term babies, and the effects of bath products on newborns. It seems that there are studies done. However, although studies on the effect of the cleaning product used in the first bath of late preterm and term newborns on the skin barrier are limited in number for term newborns, there are almost no studies for late preterm newborns. The hypotheses of this study are as follows; 1. In late preterm and term newborns, the first bath with cleaning product protects the newborns' Transepidermal Fluid Loss better than the first bath with only water. 2. In late preterm and term newborns, the first bath with cleansing product keeps the skin pH levels of newborns at a more optimal level compared to the first bath with only water.

Eligibility criteria: Inclusion Criteria:

* Born between 34 weeks + 0 days and 42 weeks + 6 days (late preterm and term),
* With a body weight of 1800g or more,
* Spontaneous breathing,
* Preterms with stable physiological parameters will be included in the study.

Exclusion Criteria:

* Receiving mechanical ventilation support,
* Mother's baby with HIV, Hepatitis B,
* Preterms who had a bath before the intervention,
* Surgical operation and incision in any area,
* Preterms with a central catheter,
* Preterms with systemic infections,
* Preterms using sedatives and / or muscle relaxants,
* Preterms with congenital or chromosomal anomalies

Primary outcomes:
measure: Transepidermal Water Loss
timeFrame: Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.
Secondary outcomes:
measure: Skin pH Level
timeFrame: Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz Universty
Study officials:
affiliation: http://hemsirelik.akdeniz.edu.tr/iletisim/
name: Emine EFE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554589: The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.
Official title: The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Effect of Drugs
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 80
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: Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.

This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.

Detailed description: Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:

Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.

Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.

Both injections will be labelled as drug A and drug B in the satellite pharmacy .

Both the attending physician, nurse and data collector will be blinded to the injection given.

Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.

Eligibility criteria: Inclusion Criteria:

1. Patients above 18 years old.
2. Patients who are admitted to ICU for more than 72 hours.
3. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.

Exclusion Criteria:

1. Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
2. Patients who have known sensitivity to Glycopyrrolate.
3. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
4. Patients with mitral stenosis

Primary outcomes:
measure: Number of suctions per day
timeFrame: 6 days
Secondary outcomes:
measure: The duration of ICU days
timeFrame: 90 days
measure: Fio2
timeFrame: 6 days
measure: Mean airway pressure
timeFrame: 6 days
measure: Positive end expiatory pressure PEEP
timeFrame: 6 days
measure: The duration of mechanical ventilation days
timeFrame: 90 days
measure: Side effects of Glycopyrrolate
timeFrame: 6 days
measure: Fluid intake
timeFrame: 6 days
measure: Total leukocyte count
timeFrame: 6 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: health care provider
name: Mohammed Abosamak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711889: Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
Official title: Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Aortic Syndrome
Type a Aortic Dissection
Keywords: Acute Aortic Syndrome
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
First posted: 2021-01-15
Enrollment: 203
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: Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.


Eligibility criteria: Inclusion Criteria:

* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
* Patients with type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled.
* The patients' age of 18 years or older.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients allergic to Ulinastatin;
* Lactating women and pregnant women;
* Patients with mental diseases;
* Refuse to participate in this study and refuse to sign the informed consent.

Primary outcomes:
measure: SOFA score
timeFrame: mean SOFA score 7 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
References:
Clinical trial NCT03129789: Volumetric Bladder Ultrasound Training for Pediatric Residents
Official title: Volumetric Bladder Ultrasound Training for Pediatric Residents: Curriculum Implementation and Learning Trajectory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Training
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Monitoring fluid balance is crucial in the care of critically ill children. There are several reasons urine output could be decreased. For example, the bladder could be empty because the patient isn't making urine due to dehydration, or the bladder could be full but the patient unable to urinate due to obstruction of the bladder outlet. It is prudent to distinguish this difference in the care of Pediatric Intensive Care Unit patients as the potential interventions vary and none is without potential drawbacks if used inappropriately. At present, there is no standard way to determine whether an oliguric patient has a bladder that is under- or over-filled. Bedside ultrasound is safe, non-invasive, painless, and relatively quick and can help assess bladder volume at the time of noted oliguria. Several studies in pediatrics endorse the use of ultrasound to approximately measure urine volume. Pediatric residents are frequently asked to manage patients' oliguria in the Pediatric Intensive Care Unit, however, they are not currently being trained how to use ultrasound to measure bladder volume. The investigators hypothesize that following a structured learning plan, by the end of their one-month Pediatric Intensive Care Unit rotations, pediatric residents will be able to independently and accurately measure bladder volume by ultrasound. Volumetric bladder ultrasound is an easily mastered bedside imaging technique. Its implementation could positively affect care of the critically ill infant or child.


Eligibility criteria: Inclusion Criteria:

* medical resident rotating through the Pediatric Intensive Care Unit

Exclusion Criteria:

* none

Primary outcomes:
measure: competency
timeFrame: 1 month
Secondary outcomes:
measure: post-instruction questionnaire
timeFrame: 1 month
measure: skill retention
timeFrame: 3 months
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Steven and Alexandra Cohen Childrens Medical Center of NY
state: New York
Study officials:
References:
Clinical trial NCT02048189: Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes
Official title: Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 14
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: This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.

In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.


Eligibility criteria: Inclusion Criteria:

* Persons who have provided written informed consent
* Age \> 18 years
* Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months
* Doses of insulin \> 0.7 U / Kg / d
* HbA1c ≥ 7.5 %
* Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin
* BMI ≥ 28.5 kg / m2
* Diabetes diagnosed for at least 10 years
* Patients able to monitor themselves and manage an insulin pump.

Exclusion Criteria:

* Patients treated with glitazones during the 3 months preceding inclusion
* Patients with proliferative ischemic retinopathy not treated by laser
* BMI \< 28.5 kg / m2
* Presence of implantable material ( CI MRI )
* Pacemaker ( CI MRI )
* Pregnancy, breast feeding
* Medically significant physical or psychiatric inability, patients under guardianship or wards of court
* The practice of violent sports
* Poor conditions of hygiene
* Professional environment of extreme cold or heat.

Primary outcomes:
measure: Mixed measurement of insulin secretion and insulin resistance
timeFrame: Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment
Secondary outcomes:
measure: Decrease in the time spent in baseline and prandial hyperglycemia
timeFrame: During the 6 months following initiation of the treatment
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besancon
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT04210089: Total Contact Soft Cast in Diabetic Foot Ulcers
Official title: Total Contact Soft Cast in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetes Mellitus
Foot Ulcer
Foot Ulcer, Diabetic
Ulcer
Ulcer Foot
Ulcer, Leg
Ankle Ulcer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 100
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: To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

Detailed description: This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods.

The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be:

* Unna boot from MPJs to just below the knee,
* Sterile Kerlix from MPJs to just below the knee
* Sterile 4 inch Kling wrap from the MPJs to just below the knee,
* Four inch coban from MPJs to just below the knee, and
* Ace wraps from MPJs to just below the knee

Removable diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options.

Eligibility criteria: Inclusion Criteria:

- Any adult with a diabetic foot ulcer

Exclusion Criteria:

* Allergy to Calamine or Zinc oxide
* Inability to have leg wrapped
* Inability to be seen weekly or as needed
* Unable or unwilling to consent
* Prisoners
* Persons lacking capacity to consent

Primary outcomes:
measure: Complete Healing Rates
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient Compliance with Use of the Total Contact Soft Cast
timeFrame: 16 weeks
measure: Patient Complications
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joseph Schuster, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06343389: Acute Kidney Injury in Patients With Liver Cirrhosis
Official title: Study of Acute Kidney Injury in Patients With Liver Cirrhosis at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury in Patients With Liver Cirrhosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cirrhotic patients ( age more than 18 years old ) in Sohag University Hospital

Brief summary: In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital.

Detailed description: Acute kidney injury (AKI) is a common condition in patients with cirrhosis. It occurs in up to 50% of hospitalized patients with cirrhosis and in 58% of such patients in the intensive care unit. AKI is one of the key predictors for short-term mortality in patients with liver cirrhosis with mortality rates as high as 90%. There is a remarkable increase in length of hospital stay with high financial burden on patients with AKI.

In general, the three main causes of AKI are renal hypoperfusion (also referred to as prerenal AKI), which in most cases is due to hypovolemia; intrinsic, structural kidney injury; and postrenal injury due to urinary obstruction. A unique cause of AKI due to renal hypoperfusion in patients with cirrhosis is the hepatorenal syndrome (HRS), which is the result of renal vasoconstriction. Early identification and management of AKI may improve outcomes.

In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients ( age more than 18 years old ) in Sohag University Hospital

Exclusion Criteria:

* patients with known preexisting chronic kidney disease
* patients who had undergone renal transplantation
* malignancy
* pregnancy

Primary outcomes:
measure: Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT03775889: Engaging School and Family in Navajo Gardening for Health
Official title: Engaging School and Family in Navajo Gardening for Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Eating Behavior
Health Behavior
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study builds on several years of working with Navajo communities to increase gardening and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the investigators propose to develop a school garden intervention to increase fruit and vegetable consumption and reduce risk for obesity among Navajo families. The intervention will integrate: an enhanced school garden plot; a curriculum for elementary school children on gardening and healthy eating; and family engagement in the curriculum and at community gardening fairs.


Eligibility criteria: Inclusion Criteria:

* Attending School Participating in Trial
* Parent able to Participate

Primary outcomes:
measure: Child healthy eating behaviors assessment
timeFrame: 1 year
Secondary outcomes:
measure: Child Gardening Participation Survey
timeFrame: 1 year
measure: Child Gardening Self-efficacy Survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Shirley Beresford
role: PRINCIPAL_INVESTIGATOR
References: