louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05436925: CGM Use in Preterm Infants
Official title: Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Very Low Birth Weight Infant
Very Preterm Maturity of Infant
Hyperglycemia
Keywords: Continuous glucose monitor
Neonates
Hyperglycemia
Hypoglycemia
Very low birth weight
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 24
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants (gestational age (GA) at birth \<31 weeks) admitted to the University of Minnesota Masonic Children's Hospital

Brief summary: Preterm infants (gestational age (GA) at birth \< 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.


Eligibility criteria: Inclusion Criteria:

* preterm infants (gestational age (GA) at birth \< 31 weeks)
* admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
* written informed consent can be secured from a parent within 96 hours of birth.

Exclusion Criteria:

* Infants born at ≥31 weeks GA
* infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development
* children experiencing severe birth asphyxia,
* children enrolled in another nutritional study,
* children likely to be transferred out of the NICU

Primary outcomes:
measure: Detection of hypo- and hyperglycemia - CGM device
timeFrame: 10 days post placement of CGM
measure: Detection of hypo- and hyperglycemia - 60 mg/dL
timeFrame: 10 days post placement of CGM
measure: Detection of hypo- and hyperglycemia - 180 mg/dL
timeFrame: 10 days post placement of CGM
measure: Detection of hypo- and hyperglycemia - AEs
timeFrame: 10 days post placement of CGM
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT06697925: Evaluating the Durability of Closure for Venous Leg Ulcers
Official title: Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Leg
Venous Leg Ulcer (VLU)
Venous Leg Ulcer
Venous Ulcer
VLU
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Serena Group
First posted: 2024-11-20
Enrollment: 150
Sex: ALL
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: Patients who achieved closure in during the THOR clinical trial

Brief summary: The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.

Detailed description: To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.

Eligibility criteria: Inclusion Criteria:

* 1. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.

Exclusion Criteria:

* 1. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.

Primary outcomes:
measure: Durability of closure
timeFrame: 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: Serena Group
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03094325: On-pump Intraoperative Echocardiography
Official title: On-pump Intraoperative Echocardiography (OPIE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septal Myectomy
Keywords: Septal Myectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study uses an ultrasound probe that is currently clinically used to assess pituitary anatomy, the Hitachi-Aloka high resolution pituitary transducer to measure left ventricular (LV) septal thickness during cardiopulmonary bypass in the performance of surgical septal myectomy. Septal thickness will be assessed and can be visualized during the procedure and if it is likely to improve the efficacy and safety of the procedure. The probe has FDA clearance for a variety of intra-operative surgical procedures but will be off-label for this cardiac surgical protocol.


Eligibility criteria: Inclusion Criteria:

* scheduled to receive a septal myectomy.

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Septal Thickness Measured Before Cardiopulmonary Bypass
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical Center Institutional Review Boards
name: Daniel Swistel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792425: Clinical Evaluation of Pink Esthetic Score
Official title: Clinical Evaluation of Pink Esthetic Score Following Delayed Implant Placement With Connective Tissue Graft With and Without Temporization in the Maxillary Esthetic Zone With Thin Gingival Biotype
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thin Gingiva
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical evaluation of pink esthetic score in delayed implants in thin gingival biotype with and without temporization in the esthetic zone

Detailed description: Clinical evaluation of the pink esthetic score with and withiut temporization in thin gingival biotype in the maxillary esthetic zone with subepithelial connective tissue graft in bith groups

Eligibility criteria: Inclusion Criteria:

* patients with missing teeth in the maxillary esthetic zone with thin gingival biotype and adequate arch space

Exclusion Criteria:

* deficient ridge , crowns on the adjacent teeth

Primary outcomes:
measure: Pink esthetic score
timeFrame: 1 year from the base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06643325: Gastric Emptying Time in Traumatic Injuries
Official title: Gastric Point-of-care Sonography with Focus on Gastric Emptying Time in Patients with Traumatic Injuries. a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Gastric Ultrasound
Sonography
Point of Care Ultrasound (POCUS)
Regurgitation
Pulmonary Aspiration During Anesthetic Induction
Trauma Patients
Keywords: point of care ultrasound
gastric ultrasound
trauma patients
aspiration
anesthesia
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 200
Sex: ALL
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: patients admitted to the emergency department with a relevant traumatic injury

Brief summary: The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.

Detailed description: The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. Patients which are admitted to the emergency department with a corresponding history are considered for inclusion. Patient with life-threatening injuries are excluded. After inclusion, the investigators plan to carry out gastric ultrasound (POCUS) all 2 hours until the operative treatment (maximal 5 examinations). To identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.

Eligibility criteria: Inclusion Criteria:

* relevant traumatic injury

Exclusion Criteria:

* life-threatening traumatic injury (immediate treatment is necessary)
* Underage
* Known pregnancy

Primary outcomes:
measure: Sonographic quality/quantity of the gastric antrum
timeFrame: 2 hour
Secondary outcomes:
measure: Pain-scale
timeFrame: 2 hour
measure: Analgetics
timeFrame: 2 hour
measure: Stress, activation of sympathic nerve system
timeFrame: 2 hour
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
References:
Clinical trial NCT04057625: Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
Official title: Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Associated Pneumonia
Lung Ultrasound
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.

Detailed description: VAP is the most frequent hospital-acquired infection in intensive care units. Depending on the diagnostic criteria used, its incidence ranges from 5% to 67%. The risk of acquiring VAP is 3% per day during the first 5 days on mechanical ventilation, and it is decreased to 1% per day for the following days.

VAP is suspected when subject shows high grade fever, increase in leukocyte count, change in color of sputum and tachypnea. It's a leading cause of mortality in 15- 65% of the cases.

Serial chest x-ray for diagnosis and follow up, done at time of diagnosis, after 5 days and after 10 days. Chest radiography is consistently carried out after LUS , LUS is done every other day, measuring the largest area of consolidation according to the intercostal space and direction of the probe . Chest radiography is read by two physicians.

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation for at least 48 hours.
* New or evolving infiltrate on chest radiograph (CXR).
* Clinical pulmonary infection score more than or equal 6

Exclusion Criteria:

* Patients who are less than 18 years old.
* Patients who have evidence of pneumonia before or prior to being mechanically ventilated.
* Patients with pulmonary infarction.

Primary outcomes:
measure: detecting ultrasound efficiency in diagnosis and follow up of vap
timeFrame: baseline
Secondary outcomes:
measure: icu stay
timeFrame: baseline
measure: hospital stay
timeFrame: basline
measure: mortality
timeFrame: basline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03938025: Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Sleeve gastrectomy
Morbid obesity
Resected gastric volume
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: final group from which data have been considered 92 patients (47females and 45 males)

Brief summary: Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.


Eligibility criteria: Inclusion Criteria:

* BMI over 60 kg/m2 in high-risk patients,
* BMI between 50 and 60 kg/m2 in nondiabetic patients,
* BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,
* patients with severe gastric inflammatory disease and H. pylori infection,
* patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding

Exclusion Criteria:

* severe and documented gastroesophageal reflux disease
* previous gastric surgery.

Primary outcomes:
measure: resected gastric volume in laparoscopic sleeve gastrectomy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: D'Ugo S, Bellato V, Bianciardi E, Gentileschi P. Impact of Resected Gastric Volume on Postoperative Weight Loss after Laparoscopic Sleeve Gastrectomy. Gastroenterol Res Pract. 2019 Dec 1;2019:3742075. doi: 10.1155/2019/3742075. eCollection 2019.
Clinical trial NCT06036225: PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing.
Official title: PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant
Keywords: Liver transplant
Liver transplantation
Prehabilitation
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: Queen's University, Belfast
First posted: 2023-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Focus groups, experience based co-design and a feasibility study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study developing a prehabilitation intervention and then testing the acceptability and feasibility of the intervention.

Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study date pending

Detailed description: This study is using focus groups and experience based co-design workshops to co-design a remote multicomponent prehabilitation intervention for patients awaiting liver transplantation.

Once the intervention is developed it will then be tested for acceptability and feasibility with the liver transplantation cohort in Belfast Northern Ireland.

Eligibility criteria: Inclusion Criteria:

* on the transplant waiting list
* grade 3 below for encephalopathy

Exclusion Criteria:

* grade 4 above encephalopathy
* Known adverse reaction to exercise
* New stroke
* lacks capacity to consent

Primary outcomes:
measure: Recruitment
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
Secondary outcomes:
measure: Physical function
timeFrame: 6 months
measure: Frailty
timeFrame: 6 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
Study officials:
affiliation: Belfast HSCT
name: Roger McCorry, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00030225: Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Official title: Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fulminant Hepatic Failure
Keywords: Fulminant Hepatic Failure
Lead sponsor: Vital Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2002-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.

Detailed description: Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
* Weight not less than 40 kilograms
* Not listed for organ transplant, but no medical contraindications for transplant

Exclusion Criteria:

* Listed for organ transplant at stud entry
* History of jaundice for greater than 28 days at screening
* Liver dysfunction due to trauma
* Concomitant serious disease

Primary outcomes:
measure: Number of subjects reaching 30-Day survival
timeFrame: Study Day 30
Secondary outcomes:
measure: 30-day transplant-free survival
timeFrame: Study Day 30
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: VitaGen
name: Patrick J Maguire, MD, PhD
role: STUDY_CHAIR
References:
citation: Millis M, Maguire P, Cronin D, Conjeevarum H, Johnson R, Conlin C, Brotherton J, O'Laughlin R, Triglia D, Piazza R: Continuous Human Liver Support As A Bridge To Transplantation. Hepatology- Vol.30, No.4 October 1999 p168A.
Clinical trial NCT06037525: Clinical Evaluation of the PowerGlide™ Pro Midline Catheter
Official title: Clinical Evaluation of the PowerGlide™ Pro Midline Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Catheter Infection
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in the vascular surgery department with above mentioned inclusion criteria

Brief summary: Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases

Detailed description: Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases. The selected patients are in need of a long-term i.v. therapy for reasons as antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.

Eligibility criteria: Inclusion Criteria:

* need for i.v. therapy longer than 7 days
* poor peripheral vein status
* Administration of alprostadil

Exclusion Criteria:

* pending dialysis
* allergy to catheter material
* minor age
* life threatening conditions
* requirement for central venous catheter

Primary outcomes:
measure: Dwelling Time
timeFrame: 0-29 days
Secondary outcomes:
measure: Administration of Alprostadil
timeFrame: 0-29 days
measure: Catheter Complications
timeFrame: 0-29 days
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
Study officials:
affiliation: University Hospital Augsburg Vascular Surgery
name: Alexander Hyhlik-Duerr, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01482325: SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
Official title: SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Pressure (Low, Normal, High)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
* Ability of a minor subject ages 7 to 18 to provide written assent
* Ability to have multiple noninvasive blood pressures taken at one sitting
* Ability to apply three lead ECG, if needed for investigation
* Ability to detect the natural presence of an irregular pulse, for irregular pulse studies

Exclusion Criteria:

* Any subject who cannot tolerate multiple blood pressure measurements
* Any subject who cannot undergo 3-lead ECG, if needed
* Any subject deemed unstable by the principal investigator
* Any subject for whom precautions are necessary because of communicable disease
* Any subject that has a known disease or condition compromises musculoskeletal integrity
* Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.

Primary outcomes:
measure: Data Collection for Engineering Development
timeFrame: After each iteration of software development
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: St. Josephs Hospital
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wisconsin Heart Hospital
state: Wisconsin
Study officials:
References: