louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03741231: 18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy
Official title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
NSCLC
Positron-Emission Tomography
Immunotherapy
18F-FDG
Keywords: melanoma
NSCLC
FDG
PET
immunotherapy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 patients (50 patients with melanoma and 20 patients with NSCLC)

Brief summary: Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

Detailed description: Study EFS in patients with melanoma or NSCLC treated by immunotherapy (anti CTLA4 or anti PDL1) and performed18FDG PET

Multicentric retrospective study

Eligibility criteria: Inclusion Criteria:

* patients treated for melanoma or NSCLC with immunotherapy (anti CTLA4 or antiPDL1)
* patients treated in Brest, Morlaix, Landerneau hospital
* patients performed FDG PET
* no opposition to study

Exclusion Criteria:

* age under 18 years old
* refusal to participate

Primary outcomes:
measure: measure of progression free survival (obtained by the delay between the date of initiation of immunotherapy until the date of first documented progression disease in patients with melanoma or NSCLC treated by immunotherapy
timeFrame: up to 50 months
Secondary outcomes:
measure: measure of overall survival (obtained by the delay between the date of initiation of immunotherapy until the date of death related to disease in patients with melanoma or NSCLC treated by immunotherapy
timeFrame: up to 50 months
measure: Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS
timeFrame: up to 50 months
measure: study the potential correlation between PET data and clinicobiological data
timeFrame: up to 50 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Landerneau
country: France
facility: CH de LANDERNEAU
city: Morlaix
country: France
facility: Centre Hospitalier de Morlaix
Study officials:
References:
Clinical trial NCT02768831: ETT Cuff Leak: TV Ratios
Official title: Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedures, Operative
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.


Eligibility criteria: Inclusion Criteria:

* Children who are scheduled to undergo GA with a cuffed ETT in place.

Exclusion Criteria:

* Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.

Primary outcomes:
measure: Intracuff pressure
timeFrame: Immediately following intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00825331: Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
Official title: Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)Using Preprocedural Marking of the Arterial Access Site and a Graduated Scheme for Removal of the Guidewire
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Catheterization
Keywords: guide wire
cardiac catheterization
ultrasound-guided examination of the access site
graduated scheme
elective and non elective cardiac catheterization
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients needing elective cardiac catheterization or PCI or emergency interventions

Brief summary: Periprocedural management of guidewire placement and removal in patients needing cardiac catheterization by use of marking of the access site and removal procedure due to a graduated scheme

Detailed description: Before elective cardiac catheterization, patients undergo an ultrasound-guided marking of the bifurcation of the common femoral artery in order to access the vascular complication rate compared tho those of non-marked patients.

Concerning the removal of the guided wire, patients will be treated due to a graduated scheme taking care of different risk levels. This procedure should improve clinical routine, but the efficacy and safety have to be assessed. Depending on the risk level, the guide wire will be removed either by an ambulance officer or emergency medical technician, assistant personal of the cardiac catheterization operating room or by a physician specialist in intensive care. Both methods should lead to quality assurance.

Eligibility criteria: Inclusion Criteria:

* elective cardiac catheterization or PCI or emergency interventions

Exclusion Criteria:

-

Primary outcomes:
measure: Decrease of vascular complications by marking of the access site
timeFrame: 18 months
Secondary outcomes:
measure: Improvement of guide wire removal procedure by using the graduated scheme
timeFrame: 18 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
name: Emilia Stegemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stegemann E, Busch L, Stegemann B, Lauer T, Hoffmann R, Heiss C, Kelm M. Evaluation of a structured training program for arterial femoral sheath removal after percutaneous arterial catheter procedures by assistant personnel. Am J Cardiol. 2015 Apr 1;115(7):879-83. doi: 10.1016/j.amjcard.2015.01.012. Epub 2015 Jan 15.
Clinical trial NCT01445431: A Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
Official title: A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uremic Xerosis
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Among adult patients with chronic kidney disease undergoing hemodialysis, what is the efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic moisturizer for uremic xerosis?

Detailed description: Objectives of the Study: The general objective of this study is to assess the efficacy and safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post and 4-weeks post application; 2) to quantitatively measure the following skin parameters at baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin lipids using a sebumeter); 3) to determine and compare changes in quality of life scores within and between treatment groups at baseline, and 4-weeks post application; and 4) to identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer for uremic xerosis

Eligibility criteria: Inclusion Criteria:

* Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis

Exclusion Criteria:

* Patients with known hypersensitivity to the tests oils were excluded from the study as well as patients with open wounds, erosions, and ulcers on the test site and paraplegics and patients with altered sensation on the test sites.
* Patients with xerosis associated with other dermatologic conditions antedating renal failure were excluded from the study.

Primary outcomes:
measure: Change in baseline overall dry skin score
timeFrame: 4 weeks
measure: Change in baseline corneometer readings
timeFrame: 4 weeks
measure: Change in baseline sebumeter readings
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Quality of life scores
timeFrame: 4 weeks
measure: Patient-assessed efficacy
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of the Philippines
name: Jacqueline Michelle G de las Alas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01921231: Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine
Official title: Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthroscopy (for Diagnostic or Therapy)
Inguinal Hernia Repair (Not Urgent)
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 119
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: Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.


Eligibility criteria: Inclusion Criteria:

* Patients with a scheduled knee arthroscopy
* Patients with a scheduled inguinal hernioplasty

Exclusion Criteria:

* Patient refusal to regional anesthesia
* American Society of Anesthesiologists score risk equal or greater than 4
* Body mass index greater than 32
* Coagulopathy
* Cutaneous infection at injection site

Primary outcomes:
measure: Length of stay in post-operative care unit (in minutes)
timeFrame: Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home
Secondary outcomes:
measure: Level of motor blocking
timeFrame: At surgical incision and at 60 minutes after anesthesia
measure: Fast-track (by-pass recovery area)
timeFrame: Participants will be assessed when surgical incision is closed with surgical staples
measure: Peak sensory block level
timeFrame: One minute before surgical incision
measure: Transient neurological symptoms
timeFrame: At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Vic Hospital Consortium
state: Catalonia
Study officials:
affiliation: Vic Hospital Consortium
name: Jordi Serrat-Puyol, MD
role: STUDY_DIRECTOR
affiliation: Vic Hospital Consortium
name: Pere Roura-Poch, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT02512731: Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Official title: Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Delayed graft function (DGF) is defined as requirement for dialysis in the first week following kidney transplantation. DGF is a common complication occurring in 39% of the deceased donor renal transplants at the investigators' institution with significant cost and outcome implications. The 3 major risk factors for DGF are donor graft characteristics, recipient factors and perioperative management. The most easily modifiable of these factors is perioperative management, in particular intraoperative fluid therapy. The investigators propose to compare the amount of fluid administered using the current standard of care with the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta, optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration fails to produce an increase in CO.


Eligibility criteria: Inclusion Criteria:

* age greater than 18 years
* signed informed consent
* listed for deceased donor transplantation.

Exclusion Criteria:

* esophageal surgery or cancer
* esophageal stricture, varices or diverticulum
* upper airway surgery
* coarctation of the aorta
* significant valvular heart disease
* clinically significant cardiac arrhythmias
* patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded

Primary outcomes:
measure: The volume of crystalloid solutions administered intraoperatively.
timeFrame: Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
citation: Corbella D, Toppin PJ, Ghanekar A, Ayach N, Schiff J, Van Rensburg A, McCluskey SA. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial. Can J Anaesth. 2018 Aug;65(8):873-883. doi: 10.1007/s12630-018-1118-y. Epub 2018 Apr 10.
Clinical trial NCT02126631: Sternal ECG Patch Comparison Trial
Official title: Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Presyncope
Palpitations
Atrial Fibrillation
Supraventricular Tachycardia
Lead sponsor: Bardy Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac patients at Auckland City Hospital, Auckland, New Zealand

Brief summary: This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.

Detailed description: The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.

Eligibility criteria: Inclusion Criteria:

* Syncope of uncertain etiology or
* Pre-syncope of uncertain etiology or
* Palpitations of uncertain etiology or
* Management of known AF/SVT patients

Exclusion Criteria:

* Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
* A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment

Primary outcomes:
measure: ECG signal quality
timeFrame: 24 hours of patient use, plus shipping and analysis time ~ 2 weeks
Secondary outcomes:
measure: Device comfort
timeFrame: 24 hours
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Bardy Diagnostics, Inc. (sponsor)
name: Jon Hunt, PhD
role: STUDY_DIRECTOR
affiliation: Auckland City Hospital
name: Warren Smith, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097031: Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
Official title: Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: blood pressure
pediatric
nursing
maintenance arterial catheter
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2010-04-01
Enrollment: 140
Sex: ALL
Maximum age (years): 93
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with congenital heart disease

Brief summary: Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution for Keeping the mean invasive blood pressure whether the continuous system and the intermittent one.


Eligibility criteria: Inclusion Criteria:

* patients in post-operative in congenital heart disease under 15 kg

Exclusion Criteria:

* no consent of parents or responses

Primary outcomes:
measure: blooding
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
References:
citation: Witkowski MC, Moraes MA, Firpo CM. Lack of difference between continuous versus intermittent heparin infusion on maintenance of intra-arterial catheter in postoperative pediatric surgery: a randomized controlled study. Rev Paul Pediatr. 2013 Dec;31(4):516-22. doi: 10.1590/S0103-05822013000400015.
Clinical trial NCT01012531: Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Official title: Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Roxall Medizin
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.


Eligibility criteria: Inclusion Criteria:

* Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Patients being in any relationship or dependency with the sponsor and/or investigator,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Primary outcomes:
measure: Symptom and medication score
timeFrame: 1 year
Secondary outcomes:
measure: Safety of the treatment during the study period
timeFrame: 1 year
measure: Documentation of adverse events
timeFrame: 1 year
measure: Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
timeFrame: 1 year
measure: Global evaluation and Quality of life questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Zentrum für Rhinologie und Allergologie
Study officials:
References: