louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00420407: Low Dose Vasopressin in Traumatic Shock
Official title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Injuries
Shock, Traumatic
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 81
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: Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.


Eligibility criteria: Inclusion Criteria:

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:

* Patient is a male or female patient presumed to be at least 18 years of age;
* Patient has a systolic blood pressure \< 90 mmHg;
* Patient has clinical evidence of acute traumatic injury;
* Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg

Exclusion Criteria:

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:

* Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
* Patient has received greater than 4 liters fluid since time of injury;
* Patient is enrolled in another shock trial;
* Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
* Female patient is pregnant by report or suspicion;
* Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);

Primary outcomes:
measure: The Primary Endpoint of This Study Will be Day 30 Mortality.
timeFrame: 30 days
Secondary outcomes:
measure: Level of Vasopressin After Trauma.
timeFrame: 12 hours
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Stephen M. Cohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg. 2011 Feb;35(2):430-9. doi: 10.1007/s00268-010-0875-8.
Clinical trial NCT01633307: Decrease the Frequency of Inappropriate Intravenous Lines in Internal Medicine
Official title: Effect of a Nationwide Teaching Program on the Frequency of Inappropriate Intravenous Lines in Internal Medicine: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Medical Patients Hospitalized in Internal Medicine
Keywords: education
intravenous infusion
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine

Detailed description: Nationwide multicentre randomized prospective controlled trial enrolling 59 french internal medicine departments. During the first study visit, we collected data of patients with intravenous infusions from each participating centre in order to determine the number and frequency of inappropriate intravenous lines. Using a computerized randomization process (on a 1:1 basis), the participating centres were randomized; Half centres (interventional group) received an educational program consisting of educational material and two educational sessions; the other half did not receive the educational program (control group). The educational program provided medical doctors with posters and slides containing information on valid indications for the prescription and use of intravenous infusions (inability to drink or eat, malabsorption, medication only available intravenously with no oral equivalent). Based on a previous pilot study, we assumed that the the frequency of inappropriate intravenous lines with be approximately 20% at baseline and hypothesize that the nationwide teaching program will decrease this frequency by 50%.

Eligibility criteria: Inclusion Criteria:

* Internal medicine department

Primary outcomes:
measure: frequency of inappropriate intravenous infusion in internal medicine department
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Lariboisiere
name: stephane J mouly, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Champion K, Mouly S, Lloret-Linares C, Lopes A, Vicaut E, Bergmann JF; PERMI Investigators Committee. Optimizing the use of intravenous therapy in internal medicine. Am J Med. 2013 Oct;126(10):925.e1-9. doi: 10.1016/j.amjmed.2013.03.028. Epub 2013 Aug 3.
Clinical trial NCT05294107: Intestinal Organoids
Official title: Intestinal Organoids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digestive System Diseases
Inflammatory Bowel Disease, Ulcerative Colitis Type
Crohn Disease
Keywords: biobank
organoids
digestive disease
inflammatory bowel disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, monocentric cohort aiming at generating 3D organoids from human digestive samples
Primary purpose: OTHER

Brief summary: Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

Detailed description: The project aims to generate a biocollection of 3D intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 to 75 years
* Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples
* Subject having signed a free and informed consent in writing

Exclusion Criteria:

* Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.
* Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)

Primary outcomes:
measure: Number of isolated intestinal crypts per biopsies
timeFrame: Day 0
Secondary outcomes:
measure: Number of differentiated organoids
timeFrame: Day 0
measure: Fold change of MUC2 expression
timeFrame: Day 0
measure: Fold change of LGR5 expression
timeFrame: Day 0
measure: KI67 expression
timeFrame: Day 0
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de RENNES-Service des Maladies de l'Appareil Digestif
Study officials:
affiliation: Rennes University Hospital
name: Guillaume BOUGUEN, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943007: Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
Official title: Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 14
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 treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed.

This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.


Eligibility criteria: Inclusion Criteria:

* supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
* indication for gross total resection (GTR) of the tumor
* age ≥18 years
* WHO Performance Scale ≤ 2
* ASA class ≤ 3
* adequate knowledge of the Dutch or French language
* informed consent

Exclusion Criteria:

* recurrent brain tumor
* multiple brain tumor localizations
* earlier skull radiotherapy
* earlier chemotherapy for GBM
* Chronic Kidney Disease or other renal function disorder
* known MR-contrast allergy

Primary outcomes:
measure: Difference in Residual tumor volume
timeFrame: <72h after surgery
Secondary outcomes:
measure: Complications, Clinical Performance, and Quality of Life
timeFrame: 3 months after surgery
measure: Survival
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Henk van Santbrink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Liege
name: Didier Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Koo van Overbeeke, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05117307: Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section
Official title: Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Postoperative Pain
Lead sponsor: Erzurum Regional Training & Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.


Eligibility criteria: Inclusion Criteria:

* Between 18-50 years
* Cesarean Section

Exclusion Criteria:

* Cesarean Section under general anesthesia
* emergency cases
* those with a body mass index greater than 35 kg/m2
* coagulopathy
* local infection

Primary outcomes:
measure: Opioid Consumption
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Visual Analog Pain Score
timeFrame: Postoperative first 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Regional Training and Research Hospital
state: Yakutiye
Study officials:
References:
Clinical trial NCT03219307: NOVOCART 3D Treatment Following Microfracture Failure
Official title: Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Articular Cartilage Defect
Keywords: cartilage repair
cartilage regeneration
cartilage reconstruction
cartilage restoration
autologous chondrocyte implantation
matrix associated chondrocyte implantation
Lead sponsor: Aesculap Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Detailed description: This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Eligibility criteria: Inclusion Criteria:

* participated in study AAG-G-H-1220
* identified as a microfracture failure patient
* voluntary consent to participate in the study

Exclusion Criteria:

* other cartilage repair procedures performed on target knee
* other conditions that would interfere with healing or evaluating outcomes
* lesions requiring implants larger than 9cm2
* non-compliance with requirements in study AAG-G-H-1220

Primary outcomes:
measure: KOOS pain subdomain score
timeFrame: 24 months
Secondary outcomes:
measure: KOOS function subdomain score
timeFrame: 24 months
measure: VAS pain scale
timeFrame: 24 months
measure: IKDC subjective scores
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: North Logan
country: United States
facility: Alpine Orthopaedics
state: Utah
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Octane Biotherapeutics, Inc.
name: Robert Spiro, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04308707: Breaking Bad News Skills of Doctors and Residents in the Surgical Setting
Official title: Breaking Bad News Skills of Doctors and Residents in Anesthesia and Surgical Specialties in Spain: a Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Communication Research
Patient Satisfaction
Communication Programs
Doctor Patient Relation
Keywords: Breaking bad news
Communication skills
Surveys and Questionnaires
Health Knowledge, Attitudes, Practice
Anesthesiology
Specialties, Surgical
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents and Doctors specialized in surgical specialties or anesthesiology.

Brief summary: Breaking bad news is a very stressful and difficult situation for health care professionals, especially clinical doctors and surgeons. Acquiring skills for this sort of communication is very important due to the large volume of times that these professionals will have to deal with it and because it can affect the doctor-patient relationship forever.

The objective of this study is to evaluate the skill of surgeons and residents in surgical specialties in breaking bad news to patients and families across Spanish hospitals. This will be done by analyzing the subjects in terms of their knowledge and experience using a specialized questionnaire based on breaking bad news protocol, designed in the "Hospital Sant Joan de Déu" Children's hospital in Barcelona.


Eligibility criteria: Inclusion Criteria:

- Doctors working in the Surgical Setting that accept and answer the specialized questionnaire.

Exclusion Criteria:

* Questionnaire answered out of the time-frame
* Incomplete questionnaires

Primary outcomes:
measure: Number of times having to communicate a bad new in the last year.
timeFrame: Two months
measure: Number of hours in training in communication and breaking bad news skills.
timeFrame: Two months
measure: Self-evaluation of the skills in breaking bad news and their self-perceived quality.
timeFrame: Two months
measure: Knowledge of Second victim concept
timeFrame: Two months
Secondary outcomes:
measure: Where have the professionals acquired their skills in breaking bad news if they have not taken a training program?
timeFrame: Two months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona, Hospital Uiversitari Mútua de Terrassa
Study officials:
References:
Clinical trial NCT05730907: Efficacy and Clinical Outcomes of Levosimendan in E-CPR
Official title: Efficacy and Clinical Outcomes of Levosimendan in E-CPR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation Complication
Keywords: levosimendan
ECPR
neurological outcome
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will retrospectively review the electronic medical records of patients who underwent E-CPR at HGH and HH. The units involved are Medical Intensive Care Unit at HGH and both intensive care units at HH i.e., Coronary and Cardiothoracic

Brief summary: Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation. Literature has demonstrated that ECMO initiated during advanced cardiopulmonary life support may confer superior survival rates with acceptable survival and a relatively low incidence of significant neurologic impairment. Levosimendan has not been investigated in patients with cardiac arrest who underwent Extracorporeal CPR (E-CPR). The current study aims to examine whether levosimendan use in the aforementioned patient population could improve survival and ECMO parameters.


Eligibility criteria: IInclusion criteria:

* Hospitalized patients ≥ 18 years of age at the time of E-CPR use
* Patients suffered cardiac arrest (IHCA or OHCA)
* Patients received VA-ECMO for E-CPR
* Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)

Exclusion criteria:

* Patients with incomplete key data
* Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)

Primary outcomes:
measure: Survival to hospital discharge
timeFrame: 6 months
Secondary outcomes:
measure: Survival to decannulation
timeFrame: 6 months
measure: long term survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
state: DA
Study officials:
affiliation: Hamad medical coproation
name: Rasha Kaddoura
role: PRINCIPAL_INVESTIGATOR
References: