louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00311272: Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer
Official title: Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: dendritic cells
antigens, neoplasm
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2006-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer cells express some common antigens. Hence it is possible to use melanoma lysate to load the dendritic cells with tumor antigens similar to the antigens expressed by the patients' colorectal cancer cells.

The patient receives 10 vaccinations with 14 days between each. The parameters for effect are changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum concentration of carcinoembryonic antigen (CEA), performance status measured by the World Health Organization (WHO) criteria, and Quality of Life.


Eligibility criteria: Inclusion Criteria:

* Verified cancer of colon or rectum
* No chemo- or radiation therapy in 6 weeks
* Performance status 0, 1, or 2 (WHO criteria)
* Adequate function of the kidneys, liver, lungs, and heart
* Adequate function of the hematopoietic system and the coagulation system
* Negative pregnancy test and adequate birth control for fertile women

Exclusion Criteria:

* Pregnancy
* Uncontrolled infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Surgical Department, University Hospital Gentofte
Study officials:
affiliation: University Hospital Gentofte
name: Anders Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burgdorf SK. Dendritic cell vaccination of patients with metastatic colorectal cancer. Dan Med Bull. 2010 Sep;57(9):B4171.
citation: Burgdorf SK, Claesson MH, Nielsen HJ, Rosenberg J. Changes in cytokine and biomarker blood levels in patients with colorectal cancer during dendritic cell-based vaccination. Acta Oncol. 2009;48(8):1157-64. doi: 10.3109/02841860903099964.
Clinical trial NCT04844372: Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism
Official title: Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture, Ankle
Fracture Leg
Keywords: Surgery for Ankle and/or leg fracture
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Surgical revision or surgery for pre-existing infection, tumour
* Intubated patient / unconscious patient
* Vasopressors before surgery
* Haemostasis disorder

Brief summary: This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.

Detailed description: Leg and/or ankle surgery is frequently performed under General Anesthesia (GA). GA is frequently associated with a high risk of hypotension with significant consequences.

Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients.

Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for GA and exposing less medical staff on patient's airway.

Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.

The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.

After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Eligibility criteria: Inclusion criteria

* ASA I - IV
* Ankle and/or leg fracture
* Operated between january 2016 and december 2020 at Montpellier

Exclusion criteria

- age \< 18 years

Primary outcomes:
measure: use of vasopressors
timeFrame: during surgery
Secondary outcomes:
measure: Total dose of vasoconstrictor
timeFrame: during surgery
measure: Duration of peroperative hypotension
timeFrame: during surgery
measure: Post-operative complications
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas SURCIN-TSEKOURAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04696172: Plasma Biomarkers of Cardiopulmonary Bypass Induced Acute Respiratory Distress Syndrome (CPB-ARDS)
Official title: Explore Potential Plasma Biomarkers of Acute Respiratory Distress Syndrome (ARDS) Using Proteomics Analysis in Patients Undergoing Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Biomarkers
Proteomics
Cardiopulmonary Bypass
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan Asia Heart Hospital
First posted: 2021-01-06
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to July 2022, in Wuhan Union hospital

Brief summary: The investigators aimed to establish a prospective cohort of patients undergoing cardiopulmonary bypass (CPB) in cardiac surgery from April 2021 to September 2022, in Wuhan. The ARDS events, ventilation time, time of extubation, oxygenation index for 3 days after operation were observed. Plasma samples were collected before CPB, and several time points after CPB. Dynamic differential proteins of ARDS after CPB were screened by DIA (Data independent acquisition) proteomics. Quantitative protein marker concentration was used to predict the occurrence of ARDS after operation, the model discrimination and calibration was assessed.


Eligibility criteria: Inclusion Criteria:

* Selective operation;
* Cardiac surgery with cardiopulmonary bypass;
* Adult patients over 18 years old;
* Signed informed consent

Exclusion Criteria:

* patients who refuse to sign the informed consent form or the attending physician refuses the patient to join the study;
* non elective surgery (surgery at non-elective time or emergency surgery);
* preoperative pulmonary insufficiency, pulmonary hypertension and pulmonary inflammation;
* the absence of any specimen and clinical data;
* patients who failed the operation, needed extracorporeal membrane oxygenation support or underwent CPB operation again within 3 days after operation;

Primary outcomes:
measure: Number of participants with postoperative ARDS events as assessed by Berlin Definition.
timeFrame: 3 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT06677372: Comparative Analysis of Core Body Temperature Measurement
Official title: Comparative Analysis of Core Body Temperature Measurement During Endoscopy: Esophageal Temperature Probe Versus Skin Temperature Sensors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temperature Change, Body
Keywords: Esophageal temperature
3M Spot On
Zero heat flux temperature
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 years and above, but under 70 years

Exclusion Criteria:

* Cases where there were serious side effects during a previous examination performed under sedation or anesthesia
* Currently undergoing treatment for a diagnosed disease
* Diagnosed with esophageal varices or having a history of esophagitis
* Having undergone esophageal and gastric resection surgery

Primary outcomes:
measure: Body temperature
timeFrame: From enrollment to the end of the treatment at 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References:
Clinical trial NCT02365272: Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department
Official title: Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: pharmacokinetics
aminoglycosides
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.


Eligibility criteria: Inclusion Criteria:

- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied

Exclusion Criteria:

* \< 18 years
* pregnancy
* burns
* amikacin treatment in the previous 2 weeks
* known allergy to aminoglycosides
* Do Not Reanimate Code ≥ 2
* Hospitalized patients with a prolonged deep venous or arterial catheder
* Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later

Primary outcomes:
measure: Number of participants with amikacin PK/PD target attainment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium
name: Sabrina De Winter, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23.
citation: De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24.
Clinical trial NCT06374472: Surgical Treatment of Fractures of the Dorso-lombar Spine
Official title: Surgical Treatment of Fractures of the Dorso-lombar Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Fracture
Keywords: Fractures
Spine
Surgery
Treatment
Evaluation
Results
Lead sponsor: Ibn Jazzar Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 cases of surgically treated thoracolumbar spine fractures

Brief summary: Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis

Detailed description: Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rarely the vital prognosis .

The thoracolumbar spine has an extended transition zone between the tenth thoracic vertebra (T10) and the second lumbar vertebra (L2): the thoracolumbar hinge which, given its particular anatomical situation between a poorly mobile thoracic segment and a dynamic lumbar segment, is the predilection for occurrence of fractures and dislocations .

The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads.

The analysis of the lesion mechanism and its consequences depends on the understanding of the classification of these lesions which are essential for therapeutic conduct .

Surgical treatment constitutes a key element in the management strategy for these fractures

Eligibility criteria: Inclusion Criteria:

* the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months

Exclusion Criteria:

* Files with insufficient follow-up, patients lost to follow-up. patients presenting: A pathological fracture. Osteoporotic collapse. Material and Methods 3 Staged trauma to the spine. A fracture due to ankylosing spondylitis

Primary outcomes:
measure: Age (in years)
timeFrame: from enrollment to the end of treatment at 4 years
measure: Sex
timeFrame: from enrollment to the end of treatment at 4 years
measure: Neurological status ( Frenkel classification)
timeFrame: from enrollment to the end of treatment at 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kairouan
country: Tunisia
facility: IBN jazzar hospital
Study officials:
References:
Clinical trial NCT03501472: Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
Official title: Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Smoking Cessation
Keywords: pictorial warning labels
risk knowledge
emotion
memory
risk perceptions
quit intentions
numeracy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2018-04-18
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks, or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests memory for numeric health risks immediately or after a six-week delay for US adult smokers. In addition, the trial tests the effects of different warning label components (e.g., whether the numeric risks are percentage or frequency), participants' level of numeric ability, and the consequences of memory for numeric risks on participant risk perceptions and quit intentions.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* have smoked 100+ lifetime cigarettes
* currently smoke "every day" or "some days."
* US resident

Exclusion Criteria:

* have not ever smoked a cigarette

Primary outcomes:
measure: numeric risk recall
timeFrame: immediately following last exposure or after 6-week delay
measure: numeric risk recognition
timeFrame: immediately following last exposure or after 6-week delay
Secondary outcomes:
measure: smoking risk perceptions
timeFrame: immediately following last exposure or after 6-week delay
measure: smoking risk knowledge
timeFrame: immediately following last exposure or after 6-week delay
measure: quit intentions
timeFrame: immediately following last exposure or after 6-week delay
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06364072: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
Official title: Open-label, Prospective Study to Assess the Safety, Tolerability, Analgesic Effect and Feasibility of Intranasal Sufentanil/Ketamine in Pediatric Patients With Moderate or Severe Pain, in an Acute Care Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Cessatech A/S
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.


Eligibility criteria: Inclusion Criteria:

* Pediatric participant, age 1 year to 17 years
* Attending an Emergency Department following an injury
* Acute pain of moderate or severe intensity
* Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria:

* Participant showing abnormal nasal cavity/airway such as:

  1. major septal deviation
  2. evidence of previous nasal disease or surgery
  3. current significant nasal congestion due to common cold
* Has received treatment with sufentanil and/or ketamine during the last 72 hours
* Known or suspected allergy to ketamine or sufentanil
* Critical, life- or limb-threatening condition requiring immediate management

Primary outcomes:
measure: To assess the safety and tolerability
timeFrame: Through study completion; up to 7 days
measure: To evaluate the analgesic effect
timeFrame: 15 and 30 min post Investigational Medicinal Product administration
Secondary outcomes:
measure: To assess medication errors
timeFrame: 0 min
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal London Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Birmingham Children's Hospital
name: Stuart Hartshorn, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543972: Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
Official title: An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Myeloid Leukemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.


Eligibility criteria: Inclusion Criteria:

* Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
* ECOG performance status 0 to 2

Exclusion Criteria:

* Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
* Allogenic transplantation within 6 months prior to inclusion
* Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
* Previous treatment with AVE9633
* Poor kidney, liver and bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Pregnant or breast-feeding women
* Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of Dose Limiting Toxicity(ies) at each tested dose level
timeFrame: Study period
Secondary outcomes:
measure: Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance
timeFrame: Study period
measure: Incidence of Adverse Events
timeFrame: Study period
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: