louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00382187: Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
Official title: A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza
pandemic influenza
influenza vaccine
adjuvanted influenza vaccine
H5N1 influenza antigen
MF59
Pandemic influenza disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers 18-60 years of age

Exclusion Criteria:

* Any auto-immune disease or other serious acute, chronic or progressive disease
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Primary outcomes:
measure: CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
timeFrame: day 1 to day 43
Secondary outcomes:
measure: Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
timeFrame: Day 1 to Day 382
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Information Services
role: STUDY_CHAIR
References:
citation: Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.
Clinical trial NCT00618787: Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
Official title: Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wounds
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.


Eligibility criteria: Inclusion Criteria:

* subject is 18 to 85 years of age inclusive
* subject has a foot ulcer
* subject has a leg ulcer
* subject has an open wound of at 1.0 cm (2)
* subject has one of the following: Palpable pulse, ABI \> 0.56 or toe pressure \> 50 mmHg
* subject or legally authorized rep is able to understand and willing to give written informed consent

Exclusion Criteria:

* subject has an allergy to Chlorhexidine Gluconate (CHG)
* subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
* subject has current malignant disease or history of malignant disease in past 5 years
* subject has inability to comply with the study protocol and procedures
* subjects who require use of topical agents other than the impregnated or regular foam dressings dressings

Primary outcomes:
measure: Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
timeFrame: 5 weeks
measure: Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.
timeFrame: Weeks 0 and 4
Secondary outcomes:
measure: Pain
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Community Dermatology and Wound Healing Clinic
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital; Dermatology Daycare & Wound Healing Clinic
state: Ontario
Study officials:
affiliation: Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic
name: R. Gary Sibbald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04679987: Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring
Official title: Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Ischemic Attack
Keywords: atrial fibrillation
transient ischemic attack
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed as acute stroke or TIA in stroke unit and neurology outpatient clinic, neurology Department, faculty of medicine, Misr University for Science and Technology (MUST) University

Brief summary: 200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.


Eligibility criteria: Inclusion Criteria:

* patient with acute ischemic stroke or TIAs (within one week of onset)

Exclusion Criteria:

* history of persistent AF
* initial ECG is AF
* primary hemorrhagic stroke
* acute large vessel dissection
* inability or refusal of consent

Primary outcomes:
measure: presence of paroxysmal Af
timeFrame: March 2019 -November 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Badr
Study officials:
References:
Clinical trial NCT03535987: Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy
Official title: Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 18
Sex: MALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men with clinically-localized or biochemically recurrent prostate cancer planned for curative-intent external beam radiation therapy with concomitant ADT for a duration of at least 6 months

Brief summary: To determine the feasibility of using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen- deprivation therapy with external beam radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Either clinically localized prostate cancer or biochemically-recurrent prostate cancer patients who are planned for at least 6 months ADT with a GnRH agonist and curative-intent radiation therapy per their oncologic providers.
* Over 50 years of age. Calculated 10-year Framingham General Cardiovascular Risk Score of ≥10% at the time of planned initiation of ADT.
* Patients must be able to read and understand English.
* Participants must sign the informed consent form.

Exclusion Criteria:

* Prior treatment with GnRH agonist therapy.
* History of active asthma or other reactive airway disease.
* Ischemic cardiac event (myocardial infarction, unstable angina) within the preceding 6 months.

Primary outcomes:
measure: number of subjects who successfully complete Rb-82 myocardial PET Imaging assessments
timeFrame: 12-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Vivek Narayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415787: Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
Official title: Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor DNA
Metastatic Prostate Cancer
Keywords: Prostate cancer
ctDNA
HR genes
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 40
Sex: MALE
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: Patients with metastatic prostate cancer

Brief summary: Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.

Detailed description: The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.

Eligibility criteria: Inclusion criteria

* Age \> 18 years
* Metastatic prostate cancer
* Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2)
* Free, informed and signed consent for research

Non inclusion criteria

* Refusal of blood and urine collection
* Patient cognitively incapable of signing consent to participate in this study
* Patient under guardianship or curatorship

Primary outcomes:
measure: Circulating plasma tumour DNA
timeFrame: Baseline
measure: Circulating urine tumour DNA
timeFrame: Baseline
measure: FFPE tissue
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Matthias Tallegas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04759287: Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation
Official title: Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation in Patients With Predicted Difficult Airway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Mask Ventilation
Difficult Intubation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly assigned into two equal groups using computer-generated randomization technique. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
Primary purpose: DIAGNOSTIC

Brief summary: C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

Detailed description: C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation.

Eligibility criteria: Inclusion Criteria:

* patients with BMI ≥ 30 kg/m2,
* presence of any predictors of difficult intubation;
* Mallampati score \> =3;
* inter-incisor distance \< 3 cm;
* thyromental distance \< 6 cm;
* neck extension \< 80°from neck flexion;
* cervical spine instability;
* history of difficult endotracheal intubation or difficult mask ventilation

Exclusion Criteria:

* patients have increased risk of pulmonary aspiration;
* have significant medical diseases in term of cardiac, respiratory, hepatic, renal,

Primary outcomes:
measure: the time required for a wake intubation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: rehab Abd Elaziz
Study officials:
affiliation: Alexandria University
name: rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04748887: Oxidative Stress Markers in COPD
Official title: Chronic Obstructive Pulmonary Disease in Non Smokers:Role of Oxidative Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Role of Oxidative Stress in COPD
Keywords: COPD , oxidative stress, Superoxide Dismutase
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control

Brief summary: Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Many of the pathogenetic pathways involved in COPD and its development tend to be driven by oxidative stress.


Eligibility criteria: Inclusion Criteria:

* 1-Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control

Exclusion Criteria:

* Patients of:

  1. Acute exacerbation, at the time of the study, of COPD.
  2. Any obvious abnormal lung parenchymal lesions.
  3. Lung cancer.
  4. Congestive heart failure.
  5. current smokers
  6. Drugs e.g anti-inflammatory , steroids ,analgesics, insulin , antineoplastic, antipsychotic drugs in the previous 2 weeks before the study.

Primary outcomes:
measure: oxidative stress markers in non smokers COPD compared to healthy control
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Egypt
facility: Minia University Hospital
state: Minia
Study officials:
affiliation: MD chest diseases
name: zainab H Saeed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02640287: Expression of Ku70/XRCC6 in Waldenström's Macroglobulinemia
Official title: Expression of Ku70/XRCC6 and Others NHEJ Components in Waldenström's Macroglobulinemia in Comparison With Others B-cell Lymphoproliferative Disorders and Normal B Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waldenström Macroglobulinemia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (L265P MYD88) has recently been described. Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group showed that MW had a specific proteomic profile, and one of the differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .

The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal B cells.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years, affiliated to the social regimen
* Written consent collected

MW group :

* Patient with a diagnosis of MW according to WHO criteria (based on the results of serum protein electrophoresis, bone marrow analysis with immunophenotyping, cytogenetic analysis and mutation L265P MyD88)

Other SLP :

* Patient with diagnosis of Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma or Multiple Myeloma

Healthy volunteers :

* volunteers without blood disorders

Exclusion Criteria:

* Women of childbearing age who do not have an effective means of contraception
* Pregnant or nursing
* Demonstration of a kappa or lambda monotype on B lymphocytes
* healthy volunteer with B-cell malignancy

Primary outcomes:
measure: Measure of ratio Ku70/XRCC6
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT02884687: Impact of Antimicrobial Stewardship in Hospital: Eight Years Review (BONANTIBIO)
Official title: Impact of Antimicrobial Stewardship in Hospital: Eight Years Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Good Use of Antibiotics
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 18
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: All antibiotics delivery

Brief summary: The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Detailed description: The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. CHRMT is a 2000-bed hospital in which 160 000 short hospitalizations are performed. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Eligibility criteria: Inclusion Criteria:

* indication of antibiotics

Exclusion Criteria:

* Non Applicable

Primary outcomes:
measure: Evolution of the antibiotics use in the hospital compared with the efficacy indicators
timeFrame: 2007 to 2014
Secondary outcomes:
measure: Antibiotics consumption
timeFrame: 2007 to 2014
measure: Bacterial resistance
timeFrame: 2007 to 2014
measure: Composite index of the appropriate use of the antibiotics
timeFrame: 2007 to 2014
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz-Thionville
name: Gregory RONDELOT, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06763887: Evaluation of Immunogenicity of COVID-19 Vaccine in Chinese Population
Official title: Evaluation of Immunogenicity of COVID-19 Vaccine in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People infected with COVID-19

Brief summary: The purpose of this study is to evaluate the immunogenicity and immune protection of COVID-19, especially the recently prevalent strains, against the background of current immunization in Chinese population


Eligibility criteria: Inclusion Criteria:

1. He was infected with COVID-19 from November to December 2022;
2. Have not been infected with COVID-19 (the subject said that he was not infected and signed the informed consent form);
3. Those who agree and sign the informed consent form.

Exclusion Criteria:

1. Missing or incomplete questionnaires that affect research results;
2. Individuals with combined dysfunction of important organs such as the heart, liver, and lungs;
3. Mental and behavioral abnormalities;
4. Intellectual disability;
5. Under 18 years old or over 75 years old;
6. Low understanding and communication skills.

Primary outcomes:
measure: PBMC
timeFrame: About two and a half years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shaanxi
Study officials:
References: