louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01335347: Safety Study of an Oral Vaccine to Prevent Avian Influenza
Official title: A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Avian Influenza
Bird Flu
Keywords: Influenza
pandemic
avian influenza
H5N1
flu
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.


Eligibility criteria: Inclusion Criteria:

* In good health as established by medical history, physical examination and laboratory testing at the time of enrollment.

Exclusion Criteria:

* Has had any other vaccines within the past 8 weeks.
* Has had prior H5 avian influenza investigational vaccine.
* Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
* History of autoimmune related disease.
* History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
* Positive serology for HIV, HCV, or HBV.
* Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain.
* History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
* Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
* Stool sample with occult blood at baseline exam

Primary outcomes:
measure: Frequency or severity of vaccine related events as measured through reported AEs
timeFrame: up to 1 year
Secondary outcomes:
measure: Magnitude of humoral immune responses to avian influenza as measured by functional assays
timeFrame: up to 1 year
measure: Magnitude of cellular immune responses to avian influenza as measured by functional assays
timeFrame: up to 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Vaxart
name: Sean N Tucker, PhD
role: STUDY_DIRECTOR
affiliation: Accelovance
name: Martin Kabongo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25.
Clinical trial NCT03963947: Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
Official title: Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis With or Without Allergic Asthma
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
Collaborators: name: Probelte Pharma S.L.U.
First posted: 2019-05-28
Enrollment: 97
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis associated with or not with asthma caused by house dust mites

Brief summary: Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients

Detailed description: This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility criteria: Inclusion Criteria:

* Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
* Positive skin testing
* Positive Serum-Specific IgE determination
* Parental or legal representative informed consent
* Clinical sintomatology on the inclusion period

Exclusion Criteria:

* Patients suffering from acute or chronic infections or inflammations
* Patients suffering from uncontrolled and severe asthma
* Patients with a known autoimmune disease
* Patients with active malignant disease
* Patients requiring beta-blockers
* Patients having any contraindication for the use of adrenaline
* Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
* Patients with immunotherapy treatment at the time of inclusion

Primary outcomes:
measure: Numbers of treatment-related local and systemic reactions
timeFrame: 1 Year
Secondary outcomes:
measure: Combined symtom and medication score of Rhinoconjunctivitis
timeFrame: 1 Year
measure: Combined symtom and medication score of Asthma
timeFrame: 1 Year
measure: Visual analogue Scale Score
timeFrame: 1 Year
measure: IgE and IgG4 specific quantification
timeFrame: 1 Year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Teknon Medical Center
Study officials:
References:
Clinical trial NCT01427647: Inflammatory Response After Colorectal Cancer Surgery
Official title: Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Laparoscopy
Anesthesia, Epidural
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Gregorio Marañon
First posted: 2011-09-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.

Detailed description: Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.

Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for colorectal cancer surgery

Exclusion Criteria:

* Emergent surgery
* Intestinal obstruction
* Contraindication for epidural catheter placement
* Concomitant autoimmune disease
* Concomitant infectious disease
* Recent corticosteroids or anti-inflammatory medications

Primary outcomes:
measure: Plasma levels of several cytokines after colorectal cancer surgery
timeFrame: within the first two days after surgery
Secondary outcomes:
measure: Incidence of adverse clinical outcomes between groups
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
Study officials:
affiliation: Gregorio Marañon Hospital
name: Patricia Duque, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268047: Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation
Official title: Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
surgery
transplantation
pulmonary vascular resistance in Fontan patients
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 50
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retro chart review

Brief summary: Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well. In some studies, an increase in pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month mortality after heart transplantation2. In this study, the investigators would like to look at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure followed by heart transplantation.

Detailed description: Children born with certain congenital heart diseases such as tricuspid atresia or single ventricle physiology normally undergo the Fontan procedure during their course of treatment. The Fontan procedure however is palliative and some of these children will eventually require heart transplantation. It has been shown in pre-clinical animal models that pulmonary vascular resistance actually increases after having the Fontan procedure however this has not been quantitated in the human population.1

This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation. We will review 50 charts at Children's Healthcare of Atlanta, Egleston Hospital. Three other United States' sites are participating. All de-identified data will be forwarded to the Great Ormond Street Hospital in London, England for study analysis. In order to ascertain this objective, the following data will be collected.

1. Diagnosis
2. Surgical History
3. Information from Pre-transplant evaluation
4. Post-transplant hemodynamics
5. Post-transplant catheterization results

Eligibility criteria: Inclusion Criteria:

* patients who have undergone the Fontan procedure
* patients cared for at Children's Healthcare of Atlanta
* Patients who have undergone a heart transplantation at Children's Healthcare of Atlanta

Exclusion Criteria:

* Those patients who do meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta
name: Kirk R. Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01796847: Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients
Official title: Influence of PTEN on Glycemic Variability and Clinical Outcome in the Critically Ill Patient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Hyperglycemia
Keywords: ICU
Hyperglycemia
Length of stay
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Truma patients admitted to general ICU

Brief summary: Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to influence glucose homeostasis by interfering in intracellular insulin signaling.

Aim of this study is to ascertain whether differential expression of PTEN in critically ill patients correlates with glycemic variability and clinical outcome.


Eligibility criteria: Inclusion Criteria:

* trauma
* provision informed consent

Exclusion Criteria:

* diabetes
* impaired fasting glucose levels

Primary outcomes:
measure: Length of ICU stay
timeFrame: Day 1 up to day 28
Secondary outcomes:
measure: Glycemic variability as expressed by standard deviation of the glycemia measurements
timeFrame: Day 1 up to day 28
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome La Sapienza, University Hospital
Study officials:
affiliation: University of Roma La Sapienza
name: Alessandro Laviano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molfino A, Alessandri F, Mosillo P, Dell'Utri D, Farcomeni A, Amabile MI, Laviano A. PTEN expression and its association with glucose control and calorie supplementation in critically ill patients. Clin Nutr. 2018 Dec;37(6 Pt A):2186-2190. doi: 10.1016/j.clnu.2017.10.021. Epub 2017 Nov 4.
Clinical trial NCT00606047: Prevalence of Femoroacetabular Impingement in Asymptomatic Patients
Official title: Prevalence of Femoroacetabular Impingement in Asymptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoroacetabular Hip Impingement Syndrome
Keywords: femoroacetabular impingement
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 200
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.

Detailed description: Participants in this study will be asked to come to the hospital after regular work hours for an MRI of the hip joints. Prior to the MRI, a physician will perform a range of motion check of the participants hips. The MRI will take approximately 20 minutes during which the participant will have to lie still in a closed space. Participants will receive a letter which can be forwarded to their family doctor if the MRI has any abnormal findings including signs of hip impingement.

Eligibility criteria: Inclusion Criteria:

* No hip problems
* No containdications to MRI

Exclusion Criteria:

- Patient does not meet above criteria

Primary outcomes:
measure: Prevalence of Femoroacetabular Impingement (FAI)
timeFrame: Pre-operative on Day of MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Paul Beaulé, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaule PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med. 2014 Apr;42(4):793-7. doi: 10.1177/0363546513518417. Epub 2014 Jan 30.
citation: Hack K, Di Primio G, Rakhra K, Beaule PE. Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am. 2010 Oct 20;92(14):2436-44. doi: 10.2106/JBJS.J.01280.
Clinical trial NCT02458547: Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 186
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.


Eligibility criteria: Inclusion Criteria:

1. Patients older than 65 years scheduled for elective or emergency hip fracture surgery.

Exclusion Criteria:

1. Patient refusal
2. Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
3. Allergies to propofol or its ingredients, soybeans or peanuts
4. Patients with altered mental status
5. Illiterate patients or foreigners

Primary outcomes:
measure: HMGB1
timeFrame: from preoperative baseline to 72hours
measure: IL-6
timeFrame: from preoperative baseline to 72hours
measure: NT-proBNP
timeFrame: from preoperative baseline to 72hours
measure: hemoglobin
timeFrame: from preoperative baseline to 72hours
measure: total lymphocyte count
timeFrame: from preoperative baseline to 72hours
measure: albumin
timeFrame: from preoperative baseline to 72hours
measure: creatinine
timeFrame: from preoperative baseline to 72hours
measure: potassium
timeFrame: from preoperative baseline to 72hours
measure: troponin-T
timeFrame: from preoperative baseline to 72hours
measure: CRP
timeFrame: from preoperative baseline to 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT06413147: Long-term Procedural and Device Related Complications of PFO Closure
Official title: Long-term Procedural and Device Related Complications of PFO Closure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patent Foramen Ovale
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent PFO closure and willing to participate in this study.

Brief summary: We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent PFO closure

Exclusion Criteria:

* Unable to complete or adhere to the study

Primary outcomes:
measure: ischemic stroke, Hemorrhagic stroke or transient ischemic attack
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
Secondary outcomes:
measure: atrial fibrillation
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
measure: Hemorrhage related to the use of antithrombotic drugs
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
measure: residual leaks
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
measure: death
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
measure: open-heart surgery
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
measure: Other severe events related to PFO closure
timeFrame: 1 month, 6 months, 1 year, 3 years, 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06521047: A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
Official title: A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Lead sponsor: CellProthera
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.

Brief summary: The PERFECT study is an observational study designed to follow patients randomised in the EXCELLENT study (NCT02669810) for 10 years.

The aim is to assess the long-term clinical outcomes for patients randomised to the Standard of Care arm or the ProtheraCytes arm.


Eligibility criteria: Inclusion criteria :

* Completion of the last visit in the EXCELLENT interventional clinical trial.
* Participation must be within 10 years after the randomization in the EXCELLENT trial

Exclusion criteria :

* Patients randomized to the ProtheraCytes® group who did not receive the product of the EXCELLENT Trial are excluded.
* Any other coexisting conditions that will preclude participation in the study or compromise ability to give informed consent

Primary outcomes:
measure: Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm
timeFrame: Through study completion, an average of 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
city: Massy
country: France
facility: Institut Jacques Cartier
city: Montpellier
country: France
facility: CHU Montpellier Arnaud-De-Villeneuve
city: Mulhouse
country: France
facility: GHRMSA
city: Pessac
country: France
facility: Hôpital Haut Levèque
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Edgbaston
country: United Kingdom
facility: BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital W Smithfield,
Study officials:
References: