louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03015454: An Algorithm Driven Sepsis Prediction Biomarker
Official title: A Randomized Controlled Clinical Trial of an Algorithm Driven Sepsis Prediction Biomarker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Severe Sepsis
Keywords: InSight
Dascena
Lead sponsor: Dascena
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2017-01-10
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: A sepsis early warning predictive algorithm, InSight, has been developed and validated on a large, diverse patient cohort. In this prospective study, the ability of InSight to predict severe sepsis patients is investigated. Specifically, InSight is compared with a well established severe sepsis detector in the UCSF electronic health record (EHR).


Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to the participating units will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.

Primary outcomes:
measure: Hospital length of stay
timeFrame: Through study completion, an average of 45 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Through study completion, an average of 45 days
Other outcomes:
measure: ICU length of stay
timeFrame: Through study completion, an average of 45 days
Locations:
city: San Francisco
country: United States
facility: UCSF Moffit-Long Hospital
state: California
Study officials:
affiliation: Dascena
name: Ritankar Das
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calvert JS, Price DA, Barton CW, Chettipally UK, Das R. Discharge recommendation based on a novel technique of homeostatic analysis. J Am Med Inform Assoc. 2017 Jan;24(1):24-29. doi: 10.1093/jamia/ocw014. Epub 2016 Mar 28.
citation: Calvert J, Desautels T, Chettipally U, Barton C, Hoffman J, Jay M, Mao Q, Mohamadlou H, Das R. High-performance detection and early prediction of septic shock for alcohol-use disorder patients. Ann Med Surg (Lond). 2016 May 10;8:50-5. doi: 10.1016/j.amsu.2016.04.023. eCollection 2016 Jun.
citation: Calvert JS, Price DA, Chettipally UK, Barton CW, Feldman MD, Hoffman JL, Jay M, Das R. A computational approach to early sepsis detection. Comput Biol Med. 2016 Jul 1;74:69-73. doi: 10.1016/j.compbiomed.2016.05.003. Epub 2016 May 12.
citation: Desautels T, Calvert J, Hoffman J, Jay M, Kerem Y, Shieh L, Shimabukuro D, Chettipally U, Feldman MD, Barton C, Wales DJ, Das R. Prediction of Sepsis in the Intensive Care Unit With Minimal Electronic Health Record Data: A Machine Learning Approach. JMIR Med Inform. 2016 Sep 30;4(3):e28. doi: 10.2196/medinform.5909.
citation: Shimabukuro DW, Barton CW, Feldman MD, Mataraso SJ, Das R. Effect of a machine learning-based severe sepsis prediction algorithm on patient survival and hospital length of stay: a randomised clinical trial. BMJ Open Respir Res. 2017 Nov 9;4(1):e000234. doi: 10.1136/bmjresp-2017-000234. eCollection 2017.
Clinical trial NCT04007354: Inflammatory Response After One-lung Ventilation According to Ventilation Methods
Official title: Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2019-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~II

Exclusion Criteria:

* preoperative inflammation (CRP\>10ng/㎖, WBC\>10,000/mm3, body temperature \>38℃)
* steroid administration within 1 month
* hematologic / autoimmune disease
* congestive heart failure (NYHA class III\~IV) or significant arrhythmia
* severe obstructive / restrictive pulmonary disease
* previous history of thoracic surgery
* BMI \>28kg/m2
* expected difficult airway

Primary outcomes:
measure: Interleukin (IL)-6
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
References:
citation: Jeon J, Sung S, Moon Y, Koo J, Hyun K, Han K, Hwang W. Comparison of early postoperative cytokine changes in patients undergoing intubated and non-intubated thoracic surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2021 Apr 8;32(3):343-350. doi: 10.1093/icvts/ivaa265.
Clinical trial NCT01099254: Internal Jugular Vein Cross Sectional Area
Official title: Effect of Position on Cross Sectional Area of IJV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Pressure
Keywords: CVP
US
Trendelenburg position
Ultrasound
Head Down Tilt
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive care unit.

Brief summary: The Trendelenburg position is used to distend the central veins, improving both success and safety of vascular cannulation. The purpose of this study is to measure the cross-sectional area of the internal jugular vein (IJV) in three different positions, using surface ultrasound.


Eligibility criteria: Inclusion Criteria:

* adult medical or surgical ICU patients who have preexisting central venous (jugular/subclavian only) catheters.

Exclusion Criteria:

* subjects with only a femoral venous catheter.
* subjects whose CVP measurement by the indwelling catheter exceeds 20cm of water.
* subjects younger than 18 years old.
* inability to obtain informed consent from the subject or the subjects authorized representative.

Primary outcomes:
measure: Effect of trendelenburg and reverse trendelenburg position on the cross sectional area of the internal jugular vein
timeFrame: At time of data collection: physiologic study
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Roy J. & Lucille A. Carver College of Medicine, University of Iowa
name: Gregory A Schmidt, mD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazaral M, Harlan S. Ultrasonographic anatomy of the internal jugular vein relevant to percutaneous cannulation. Crit Care Med. 1981 Apr;9(4):307-10. doi: 10.1097/00003246-198104000-00004.
citation: Vinayak AG, Levitt J, Gehlbach B, Pohlman AS, Hall JB, Kress JP. Usefulness of the external jugular vein examination in detecting abnormal central venous pressure in critically ill patients. Arch Intern Med. 2006 Oct 23;166(19):2132-7. doi: 10.1001/archinte.166.19.2132.
citation: Nassar B, Deol GRS, Ashby A, Collett N, Schmidt GA. Trendelenburg position does not increase cross-sectional area of the internal jugular vein predictably. Chest. 2013 Jul;144(1):177-182. doi: 10.1378/chest.11-2462.
Clinical trial NCT06073054: A Pharmacist Intervention to Improve Mother and Child Health
Official title: A Pharmacist Intervention to Improve Mother and Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-10-10
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:

* Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health and the health of their child, and text us their blood pressure measurements?
* Will contact with the pharmacist improve the health of the mother and/or the child?

Participants will:

* complete a baseline demographic survey,
* be given a blood pressure cuff and taught how to use it,
* be asked to text us their blood pressure values 2 times per day for 7 days after enrollment,
* complete a phone call with a pharmacist discussing their health and the health of their baby,
* text us their blood pressure 1 time per day for 3 days 1 month after enrollment,
* have a 1 month follow-up phone call with the research pharmacist, and
* complete an exit survey to provide feedback about the study.


Eligibility criteria: Inclusion Criteria:

* biological mother of a baby attending a 1-week to 6-month well-child visit,
* received prenatal care at University of Iowa Hospitals and Clinics,
* had at least 2 elevated blood pressures (\>= 130 mmHg systolic or \>= 80 mmHg diastolic) during pregnancy,
* owns a smartphone

Exclusion Criteria:

* arm circumference \> 17 inches,
* prisoner status
* unable to provide own written informed consent

Primary outcomes:
measure: Number of Participants Who Talk to Research Pharmacist
timeFrame: Through study completion, an average of 30 days
measure: Number of Participants Who Return BP Measurements
timeFrame: Through study completion, an average of 30 days
measure: Percentage of Well-Child Visits Attended
timeFrame: Through study completion, an average of 30 days
measure: Percentage of Vaccinations Received
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Number of BP Measurements Submitted
timeFrame: Through study completion, an average of 30 days
measure: Blood Pressure Control
timeFrame: Through study completion, an average of 30 days
measure: Study Satisfaction
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Hao Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04091854: The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus
Official title: A Study to Observe the Progress of Diabetes Mellitus After 52 or 28 Weeks of HMS5552 Treatment for Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes Mellitus
Keywords: Glucokinase Activator
Glucose control
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 24
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: In this study, subjects with type 2 diabetes mellitus treated with HMS5552 were screened to meet the target of glucose control when they completed 52 or 28 weeks of HMS5552 treatment respectively.

Brief summary: At present, there are few studies on the clinical remission rate of diabetes after one year discontinuation of oral hypoglycemic drugs after intensive treatment. HMS5552 is a kind of GKA hypoglycemic drug. This study intends to observe the clinical remission rate of diabetes mellitus, beta cell function and blood sugar fluctuation of patients with type 2 diabetes mellitus who have been treated with HMS5552 for 52W or 28W and whose glucose control is up to the standard.


Eligibility criteria: Inclusion Criteria:

* Complete HMS5552 treatment and safety visit;
* HbA1c \< 8.0% was detected in our laboratory;
* Researchers judged the stability of glucose control based on the data of subjects'visits during HMS5552 treatment and the indicators of our hospital;
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise;
* Willing to sign written informed consent and abide by the research program.

Exclusion Criteria:

* There was a state of illness in the subjects who could not complete the follow-up during the observation period.
* The researchers judged that subjects'compliance with HMS5552 was affected during treatment.

Primary outcomes:
measure: HbA1c
timeFrame: 4 weeks
measure: Fasting glucose
timeFrame: 4 weeks
measure: Postprandial glucose
timeFrame: 4 weeks
measure: C peptide
timeFrame: 4-8 weeks
Secondary outcomes:
measure: TNF-α
timeFrame: 52 weeks
measure: IL-6
timeFrame: 52 weeks
measure: 8-iso PGF2α
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01744054: Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Official title: Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Liver Neoplasms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 57
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: The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.


Eligibility criteria: Inclusion Criteria:

* Participant must successfully complete the MRI screening form if receiving an MRI
* Participant must be scheduled to undergo radioembolization for any indication
* Participant must be ≥ 18 years of age
* Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria:

* Participant must not have any contraindications to MRI scanning
* Patient must not be pregnant or breastfeeding
* If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR \< 30 mL/min/1.73 m2) measured within the past 60 days
* If agreeing to MRI contrast, participant must not be on dialysis
* If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
* PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization

Primary outcomes:
measure: Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
timeFrame: 1 day (one time event for patient)
measure: Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
timeFrame: 1 day (one time event for patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Parag Parikh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997554: Validation of a New TSH Test
Official title: Validation of a New TSH Test for Early Screening of Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sub-clinical Hypothyroidism
Hypothyroidism
Euthyroidism
Keywords: TSH Testing
sub-clinical hypothyroidism
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 1654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this research project, which is realised with the partnership of the enterprise Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an earlier screening of hypothyroidism. A serum bank will be conserved in the "Centre de Biologie Sud" ("Groupement Hospitalier Lyon Sud").

The serum samples will be assayed locally for the usual medical support to patients and after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new diagnostic test. The results obtained from the two techniques will be compared.

The validation of this new TSH test represents a major advancement, since it could bring in the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic patients with subclinical hypothyroidism.


Eligibility criteria: Inclusion Criteria:

1. Subjects more than 18 years old
2. Thyroid test planned in the normal health care of patients
3. Subject who has been informed about "TSH Testing" study with a complete Subject Information Sheet and who has signed a consent form
4. Subject covered by the Health Social System

Exclusion Criteria:

1. Subjects with hyperthyroidism (clinical symptoms : weight loss with unaltered appetite, palpitations in the absence of cardio-vascular pathology, unusual and recent nervousness)
2. Subject not covered by the Health Social System
3. Subject who already participates to another clinical research study, which might interfere with TSH Testing Study
4. Pregnant, parturient or breastfeeding mother
5. Person deprived of freedom by a judicial or administrative decision
6. Person under a legal guardianship or unable to consent (MMSE score \< 20/30 for the patients for whom this test has been performed).

Primary outcomes:
measure: TSH assay of all the patients samples conserved in the serum bank with two techniques: technique IRMA (Immuno Radiometric Assay) and the new technique developed by Siamed'Xpress (Marseille)
timeFrame: Recruitment period : 30 months (starting from February 2012) in order to establish a serum bank
Secondary outcomes:
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier de Chambéry
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT01984554: Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
Official title: Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia (IDA)
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects presenting for IDA treatment

Brief summary: The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Detailed description: The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Eligibility criteria: Inclusion Criteria:

* Must present for the first dose of a current cycle of IV treatment for IDA
* Must be over 18 years of age
* Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
* Must be able to read and understand English.

Exclusion Criteria:

* Subjects not diagnosed with IDA.
* Subjects requiring more than one treatment cycle within 30 days.
* Subjects receiving maintenance IV iron therapy.
* Subjects treated with IV iron within the 30-day period prior to study enrollment.
* Subjects who received investigational medication in the six months prior to the study.

Primary outcomes:
measure: Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).
timeFrame: 30 day observation period
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02578654: Interventions to Improve HIV Care Engagement After Hospital Discharge
Official title: Interventions to Improve HIV Care Engagement Within 30 Days After Hospital Discharge Among HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A quasi-experitmental study of the efficacy interventions, including additional HIV care team daily inpatient round and three telephone calls to remind the upcoming clinic appointment, in improving HIV care engagement within 30 days after hospital discharge among HIV-infected patients.


Eligibility criteria: Inclusion Criteria:

* HIV-infected patients hospitalized at Thammasat University Hospital during the study period

Exclusion Criteria:

* The patients who die during admission, are readmitted prior to 30 days after discharge or with incomplete data
* Readmission episodes of the same enrolled patients during the study period

Primary outcomes:
measure: Number of HIV-infected patients who come to the designated HIV clinic for follow-up within 30 days after hospital discharge divided by the total number of enrolled HIV-infected patients
timeFrame: 30 days
Secondary outcomes:
measure: Factors associated with no follow-up withing 30 days after hospital discharge(analyzed in multivariable logistic regression)
timeFrame: 30 days
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Department of Internal Medicine, Faculty of Medicine, Thammasat University
Study officials:
References:
citation: Khawcharoenporn T, Damronglerd P, Chunloy K, Sha BE. Enhanced inpatient rounds, appointment reminders, and patient education improved HIV care engagement following hospital discharge. Int J STD AIDS. 2018 Jun;29(7):641-649. doi: 10.1177/0956462417749420. Epub 2018 Feb 5.