louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06920420: Novel Biomarkers Related Xuebijing Injection Improves Sepsis
Official title: Xuebijing Injection Regulates Endothelial Cell Panapoptosis in Treating Sepsis Through PCDHAC2/BAX/AIM2 Pathway
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sepsis

Brief summary: Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.


Eligibility criteria: Inclusion Criteria:

1. Meeting the Sepsis 3.0 diagnostic criteria;
2. SOFA score ≥ 2 and \< 13;
3. Signed informed consent.

Exclusion Criteria:

1. Age \<18 years or \>75 years;
2. Pregnant or lactating women;
3. Presence of severe primary diseases including malignant tumors severe hematologic disorders and HIV infection;
4. Current use of immunosuppressants or history of organ transplantation within the past 6 months;
5. Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.

Primary outcomes:
measure: Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.
timeFrame: Day7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00784420: Drug Interaction Study Between Raltegravir And UK-453,061
Official title: Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Interaction, Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the effect of steady state raltegravir on the steady state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state pharmacokinetics of raltegravir.


Eligibility criteria: Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive; Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication; Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Primary outcomes:
measure: Raltegravir plasma pharmacokinetic parameters: Cmax and AUC12
timeFrame: 11 days
measure: UK-453,061 plasma pharmacokinetic parameters: Cmax and AUC24
timeFrame: 11 days
Secondary outcomes:
measure: Raltegravir plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C12h
timeFrame: 11 days
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
timeFrame: 11 days
measure: UK-453,061 plasma pharmacokinetic parameters: Tmax, t1/2, AUCinf, and C24h
timeFrame: 11 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01736020: Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
Official title: Developing Anesthesia as PTSD Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, Irvine
First posted: 2012-11-29
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.


Eligibility criteria: Inclusion Criteria:

* Healthy adults.
* Between the ages of 18 and 35.

Exclusion Criteria:

* Pregnancy.
* Left-handed.
* Unusual facial anatomy.
* History of esophageal reflux.
* Respiratory problems.
* Central nervous system disorders.
* Cardiovascular problems.
* Kidney disease.
* Diabetes.
* History of Substance abuse.
* History of adverse anesthetic reactions.
* Hepatitis.
* Failure to pass MRI screening questionnaire.
* Fear of small-enclosed spaces.
* Mental illness.
* Non-native English speakers.

Primary outcomes:
measure: Number of events remembered
timeFrame: Day 4
Secondary outcomes:
measure: Event-related fMRI BOLD signals
timeFrame: Baseline
Other outcomes:
measure: Tolerability
timeFrame: Baseline
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine and Long Beach VA Medical Center
name: Michael T Alkire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271320: Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
Official title: Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: systemic sclerosis patients

Brief summary: The primary objective is to assess the burden of aesthetic complication in systemic sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the appearance. Aesthetic burden will be assessed through several scales and compared to a control group of health subjects.


Eligibility criteria: Inclusion Criteria:

* systemic sclerosis according to ACR-EULAR 2013

Exclusion Criteria:

* non French native
* aesthetic sequel from other conditions

Primary outcomes:
measure: Visual scale for aesthetic burden
timeFrame: Baseline
Secondary outcomes:
measure: Satisfaction with Appearance Scale (SWAP)
timeFrame: Baseline
measure: Derriford Appearance Scale-59 (DAS)
timeFrame: Baseline
measure: Multidimensional Body self Relations Questionnaire (MBSRQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU
Study officials:
References:
Clinical trial NCT05342220: Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion
Official title: Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.


Eligibility criteria: Inclusion Criteria:

* Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
* Age \> 18 years
* Consent capacity

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Lack of consent capacity

Primary outcomes:
measure: Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with short-term cardioversion success
timeFrame: 30 seconds
measure: Minimum energy required for successful electrocardioversion (in Joule)
timeFrame: 30 days
measure: Cumulative energy applied for successfull electrocardioversion (in Joule)
timeFrame: 30 days
measure: Cumulative number of shocks delivered for successfull electrocardioversion
timeFrame: 30 days
measure: Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden
state: Hessen
Study officials:
References:
Clinical trial NCT00878020: Safety Study to Evaluate BMS-830216 in Healthy Subjects
Official title: Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Primary outcomes:
measure: Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
timeFrame: Within the 10 days after study drug administration
Secondary outcomes:
measure: Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose
timeFrame: Within the 10 days after study drug administration
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05909020: EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem
Official title: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Leeds
First posted: 2023-06-18
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Recruitment will aim for variation in age, ethnicity, socio-economic status, presenting symptoms.

Clinicians Clinical staff involved in HNC diagnosis. Varying in seniority (consultant, registrar) and specialty (ENT, maxillofacial)

Brief summary: Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway?

Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

Detailed description: The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.

Eligibility criteria: Inclusion Criteria:

Patients:

* Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC
* Participants willing and able to give informed consent for participation in the study.

Clinicians:

* Staff at participating sites involved in the diagnostic pathway for people with suspected HNC.

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria.

Primary outcomes:
measure: Inventory and specification for the SYmptom iNput Clinical (SYNC) system
timeFrame: September 2022 - August 2023
Secondary outcomes:
measure: To further explore the current suspected HNC pathway and the language used when discussing symptoms.
timeFrame: September 2022 - August 2023
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: Luton
country: United Kingdom
facility: Luton & Dunstable University Hospital
city: Oxford
country: United Kingdom
facility: Oxford NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Vinidh Paleri
role: STUDY_CHAIR
References:
Clinical trial NCT03292120: Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂
Official title: Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of septic shock
* Initial lactate in patients should be≥ 2 mmol / L.
* The presence of circulatory insufficiency defined by a systolic blood pressure ≤ 90 mmHg (or a drop in blood pressure≥ 50 mmHg in hypertensive patients)
* One or more of the following: oliguria defined as diuresis≤ 0,5 mL/ kg / h for at least two hours; the presence of signs of cerebral hypoperfusion; the highlighting of mottling
* The presence of a femoral arterial catheter and a central venous line in the superior vena cava position
* Hemodynamic monitoring with semi-invasive monitoring of cardiac output with thermodilution

Exclusion Criteria:

* Patient no longer in the initial phase of septic shock
* Absence of semi-invasive cardiac monitoring with thermodilution
* Vulnerable people
* Absence of informed consent

Primary outcomes:
measure: measure of the SOFA score
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assisitance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: jean olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02174120: The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Target Controlled Infusion
General Anesthesia
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.


Eligibility criteria: Inclusion Criteria:

* Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form

Exclusion Criteria:

* Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days

Primary outcomes:
measure: Heart rate
timeFrame: Baseline to the end of the operation, expected to be about 6 h
measure: Blood pressure
timeFrame: Baseline to the end of the operation, expected to be about 6 h
measure: Concentration of cortisol
timeFrame: from baseline to the end of the operation, expected to be about 6 h
Secondary outcomes:
measure: Use of vasoactive agent
timeFrame: from the beginning of induction to the end of the operation, expected to be about 6 h
measure: The time from stop of remifentanil to awake
timeFrame: The time from stop of remifentanil to awake, expected to no more than 15 min
measure: Severity of agitation
timeFrame: Within 24 h after the operation
measure: Postoperative nausea and vomiting
timeFrame: Within 24 h after the operation
measure: Dose of etomidate and propofol
timeFrame: From the beginning of induction to the end of the operation, expected to be about 6 h
measure: Intraoperative awareness
timeFrame: From the beginning of induction to the end of the operation, expected to be about 6 h
measure: Expense of anesthetics
timeFrame: From the beginning of induction to the end of the operation, expected to be about 6 h
measure: Allergic reaction
timeFrame: From beginning of induction to 24 h after the operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05148520: Provision of Service of a YQL Programme For Youth Smokers
Official title: Provision of Service of a Youth Quitline Programme For Youth Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Keywords: smoking cessation service
youth smoker
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 400
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months. It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.

Detailed description: This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022). Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors. We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.

Eligibility criteria: Inclusion Criteria:

* Aged 25 or below
* Self-reported to smoke any types of tobacco products within the past 1 month
* Speak Cantonese and
* Provide verbal consent to counselling service.

Exclusion Criteria:

* have psychiatric disease
* and/or currently receive any smoking cessation intervention from other service providers

Primary outcomes:
measure: Self-reported 7-point prevalence
timeFrame: at the 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ka Yan Ho
state: Hong Kong,China
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ka Yan Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References: