louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02732327: Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
Official title: A Single-Center, Randomized, Open-label, Prospective, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Vancomycin or Linezolid Versus Standard of Care Plus Vancomycin or Linezolid as Empiric Therapy in Febrile Neutropenic Adults With Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Febrile Neutropenia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 2
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 study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer


Eligibility criteria: Inclusion Criteria:

* Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
* Requires hospitalization for intravenous (IV) empiric antibiotic therapy

Exclusion Criteria:

* Fungal or viral infection requiring additional therapy
* Known acute viral hepatitis
* Known to be human immunodeficiency virus (HIV) positive
* Expected requirement for hemodialysis while on study therapy
* Received \>24 hours of systemic antibacterial therapy within 72 hours of initiation of inpatient IV study drug
* Past or current history of epilepsy or seizure disorder
* Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less.

Primary outcomes:
measure: Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)
timeFrame: Up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Allergan
name: David Melnick, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01770327: Influence of Different Sugary Beverages on Thirst Sensation
Official title: Influence of Different Sugary Beverages on Thirst Sensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thirst
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if water and three different sugary beverages (milk, Orange juice and iced tea) have the same effect on thirst.

Detailed description: Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be collected for analysis of blood glucose, osmolality and plasmatic sodium. They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7). After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.

Eligibility criteria: Inclusion Criteria:

* body mass index(BMI) between (18,5 - 27,5 kg/m2)
* regular consumers of breakfast
* stable in weight for the past 6 months
* not dieting to gain or lose weight
* like all drinks and food available in study

Exclusion Criteria:

* pregnant and nursing women
* smokers
* athletes
* subjects under medication(except oral contraceptives in women)

Primary outcomes:
measure: Motivational Ratings
timeFrame: 1 day
Secondary outcomes:
measure: Glycaemia
timeFrame: 1 day
measure: Amount of water ingested
timeFrame: 1 day
measure: Food Behavior After Intervention
timeFrame: 1 day
measure: Blood osmolality
timeFrame: 1 day
measure: Plasmatic Sodium
timeFrame: 1 day
measure: Hydration parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Nutrition and Food Sciences - University of Porto
Study officials:
affiliation: FCNAUP
name: Pedro R Carvalho, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179127: Use of Insulin Glargine to Treat Diabetic Ketoacidosis
Official title: Early Use of Insulin Glargine in Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Keywords: Pediatrics
Diabetes
Emergency Care
Endocrinology
Critical Care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.


Eligibility criteria: Inclusion Criteria:

* Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
* Established history of insulin dependent diabetes

AND:

* Chief c/o hyperglycemia or vomiting
* Venous pH \< 7.24
* Serum Bicarbonate \< 18
* Blood glucose \> 150
* Urinary Ketones

Exclusion Criteria:

* Age \< 6y.o.
* New onset diabetes
* Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
* Venous pH \> 7.24
* Serum Bicarbonate \> 18
* Pregnancy
* Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit

Primary outcomes:
measure: Time of Acidosis Correction
timeFrame: Minutes
Secondary outcomes:
measure: Time on Insulin Drip
timeFrame: Minutes
measure: Total Hospital Stay
timeFrame: Days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Monroe Carell Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Sheila McMorrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05438927: Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
Official title: Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Nutritional Support
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Canopy Cancer Collective
First posted: 2022-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
* Planning to initiate chemotherapy under the guidance of Moffitt
* Able to speak and read English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a second primary GI cancer
* ECOG status of 2 or greater
* Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer
* Use of parenteral or enteral nutrition
* Presence of malignant ascites
* The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

Primary outcomes:
measure: Recruitment Rate - Feasibility
timeFrame: 12 Months
measure: Data Collection - Feasibility
timeFrame: 12 Months
measure: Participant Rating on Ease of Use for the Mobile Application - Usability
timeFrame: 12 Months
Secondary outcomes:
measure: Participant Compliance with Palliative Care Visits - Intervention Adherence
timeFrame: 12 Months
measure: Participant Compliance with Dietician Visits - Intervention Adherence
timeFrame: 12 Months
measure: Participant Compliance with Dietary Log - Intervention Adherence
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi Tabriz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01395927: A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
Official title: An Open-Label, Fixed-Sequence Study to Assess Effects of Steady-State Rifampin on the Single-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Canagliflozin
Rifampin
Pharmacokinetics
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers before and after the administration of multiple-doses of rifampin.

Detailed description: This is an open-label (volunteer and study staff will know the identity of study drugs assigned) study of canagliflozin and rifampin taken in a sequential order by healthy volunteers for up to 12 days. Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet and/or two 300 mg rifampin capsules daily in sequential order as follows: on Day 1 volunteers will take one 300-mg canagliflozin tablet, on Days 4 to 9 volunteers will take two 300-mg rifampin capsules once daily, on Day 10 volunteers will take one 300-mg canagliflozin tablet + two 300-mg rifampin capsules, and on Days 11 and 12 volunteers will take two 300-mg rifamplin capsules once daily.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive)

Exclusion Criteria:

* History of or current medical illness deemed clinically significant by the Investigator

Primary outcomes:
measure: Plasma concentrations of canagliflozin
timeFrame: Day 1 up to Day 13
Secondary outcomes:
measure: Plasma concentrations of Rifampin
timeFrame: Day 9 up to Day 13
measure: Adverse events reported
timeFrame: For approximately 13 days
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06983327: Brief Intervention for Chronic Pain and History of Stressful Experiences
Official title: Brief Intervention for Chronic Pain and History of Stressful Experiences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Trauma
Adverse Childhood Experiences
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to understand whether a brief, three session program can be helpful in reducing symptoms related to both chronic pain and stressful experiences/trauma.


Eligibility criteria: Inclusion Criteria:

* Presence of a chronic pain condition (pain for at least 3 months or more)
* History of psychosocial trauma or stressful experience (Adverse Childhood Events questionnaire \[ACEs\] score of ≥ 3 OR Trauma History Questionnaire Score \[THQ\] of ≥ 2)
* English fluency
* Access to a smartphone, laptop, or computer
* Able to participate in the intervention via a virtual platform

Exclusion Criteria:

* Unable to participate in 3 weekly sessions
* Unable to complete study procedures due to the presence of delirium, dementia, psychosis, or other cognitive impairment

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: At screening
measure: Treatment Completion
timeFrame: From enrollment to end of treatment at 4 weeks
measure: Feasibility of Data Collection
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
measure: Treatment Credibility
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
measure: Treatment Helpfulness
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Secondary outcomes:
measure: Pain Interference
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
measure: Pain Catastrophizing
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
measure: Anxiety
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
measure: Kinesiophobia
timeFrame: At end of treatment at (~4 weeks post-enrollment), and at 1-month follow-up (~8 weeks post-enrollment)
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02030327: Proteomics in Multiple Trauma to Identify Organ Failure
Official title: Analysis of Predictive Parameters by Proteomics for Early Diagnosis of Organ Dysfunction in Multiple Trauma Patients - A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Trauma
Keywords: proteomics
multiple trauma
organ dysfunction
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older than 18 years multiple trauma patients ISS \>16

Brief summary: To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.

Detailed description: The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* multiple trauma patients
* ISS \>16

Exclusion Criteria:

* children
* ISS \<16

Primary outcomes:
measure: Number of patients with disease or death vs. healthy
timeFrame: Day 0 until day 20
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: UK Köln
name: Jochen Hinkelbein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128827: Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol
Official title: Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 170
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).


Eligibility criteria: Inclusion Criteria:

* 0 to 18 years old inclusive, male and female patients
* Only patients with written informed consent signed by parents or legal guardians will be enrolled
* In children 10 and older, patient's assent will be obtained

Exclusion Criteria:

* Patients who are unable to give their consent and/or assent
* Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications

Primary outcomes:
measure: Accuracy of RAM sensor to detect respiration rate
timeFrame: 1-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
References:
Clinical trial NCT04718727: Olanzapine for the Prevention of Postoperative Nausea and Vomiting
Official title: Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Nausea
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
Primary purpose: PREVENTION

Brief summary: Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.

Detailed description: Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients
* undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia
* patients have at least two of the four Apfel risk factors for PONV2
* Lack of history of psychiatric and psychotic illnesses.

Exclusion Criteria:

* ASA III and ≥ IV patients
* Psychological diseases
* History of chemotherapy
* have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.

Primary outcomes:
measure: nausea and/or vomiting score
timeFrame: first 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut Governorate
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Amani H Abdel-wahab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909227: Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years
Official title: Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Anesthesia
Infant
Keywords: pediatric
anesthesia
lactate
complications
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring a surgical procedure

Brief summary: This study will investigate if the dosage of veinous lactate at the end of a surgical procedure is related to post-operative complications occurring within 3 months in young infants aged 0-1 years.

Blood samples are acquired routinely before emergence of general anesthesia, from the IV line put in place for anesthesia.

The investigators hypothesized that elevated lactates would be associated with more postoperative complications in this population, as is the case in adults.


Eligibility criteria: Inclusion Criteria:

* surgery under general anesthesia
* age \< 1 year

Exclusion Criteria:

* ambulatory surgery
* cardiac surgery
* preoperative hemodynamic instability
* Weight \< 2 kg

Primary outcomes:
measure: Post-operative complications occurring within 3 months after surgery
timeFrame: within 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Armand Trousseau University Hospital
Study officials:
affiliation: Armand Trousseau University Hospital
name: Nada Sabourdin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Armand Trousseau University Hospital
name: Isabelle Constant, MD, PhD
role: STUDY_CHAIR
References:
citation: Zheng D, Yu GL, Zhou YP, Zhang QM, Wang CG, Zhang S. Association between lactic acidosis and multiple organ dysfunction syndrome after cardiopulmonary bypass. PeerJ. 2024 Jan 31;12:e16769. doi: 10.7717/peerj.16769. eCollection 2024.
citation: Stephens EH, Epting CL, Backer CL, Wald EL. Hyperlactatemia: An Update on Postoperative Lactate. World J Pediatr Congenit Heart Surg. 2020 May;11(3):316-324. doi: 10.1177/2150135120903977.