cyrilzakka/clinical-trials huggingface dataset:
Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable, as judged on the basis of history and concurrent diseases
* Subject understands procedure of the protocol and is willing to comply with the protocol

Exclusion Criteria:

* Scheduled to receive another vaccine during the study
* Received influenza HA vaccine within 180 days prior to screening
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures
* History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
* Confirmed diagnosis of influenza within 84 days prior to screening test
* Body temperature of ≥37.5°C on Day 1 (before vaccination)
* Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody
Restoring Mobility: Roles of Percutaneous Consolidation for Pelvic Ring Bone Lesions

Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions.


Eligibility Criteria:
Inclusion :

- Individuals with cancer who underwent percutaneous screw fixation or cementoplasty either for prophylactic consolidation or treatment of pathologic fractures in pelvic ring tumors.

Exclusion criteria :

* minors
* incompetent adults
* refused to participate in the study
* pregnant women
FAZA PET IMAGING IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

In renal cell carcinoma (RCC) patients, lymph node metastases detection and treatment are the most critical issues in daily clinical decision-making. Indeed, conversely to other oncological settings, a) nodal status imaging, b) sentinel node technique and c) standard lymphadenectomy have been demonstrated inadequate in the staging and management of RCC patients. A novel, accurate, standardized imaging technique is urgently needed in RCC setting to detect macro and micro nodal invasion, to identify those patients who are at higher risk of having nodal metastases, to accurately plan the best management. Recent studies suggested combining 18F-FAZA PET with CT scanning in the detection of cancer-induced hypoxia.The investigators propose to test 18F-FAZA PET-CT in detecting nodal metastases to improve the management of RCC patients.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years with diagnosis of RCC;
* patients candidates to radical nephrectomy and extended lymphadenectomy
* clinical T4 cancers or renal masses with evidence of lymphadenopathies at preoperative CT scan or larger tumor (max diameter\>10 cm)
* performance status 0-1;
* expected survival time of at least 3 months;
* recovery from toxic effects of any previous treatment;
* serum biochemical and haematological measurements within healthy parameters.
* Female patients of childbearing age were requested to have a negative pregnancy test
* ability to understand and understand informed consent
* acceptance and signature of informed consent

Exclusion Criteria:

* other medical conditions that might limit the amount of antibody to be administered;
* New York Heart Association Class III/IV cardiac disease;
* pregnancy and breastfeeding
* eGFR\<30;
* women of child-bearing age who do not agree to use contraceptives to avoid pregnancy;
* history of autoimmune hepatitis;
* allergy to iodine;
* unavailability or immunological and clinical follow-up assessments;
* participation in another clinical trial involving an investigational agent within 4 weeks of study enrolment
Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS

Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective.

Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program, higher than 18 years, under antiretroviral therapy with CD4+ ≥ 350/mm3. Research Ethical Committee of the institution approved the study and the participants sign the informed consent and informed. All subjects underwent an exercise program in conformity to American College of Sports Medicine, 3 times per week during 40 minutes. Were evaluated the quality of life (QoL) with the Quality of Life - HAT - QoL and the sleep quality (SQ) with the Pittsburg questionnaire. The subjects were evaluated before the start of exercise program and in three times: short-term (2 to 4 months), medium-term (between 5 and 17 months) and long-term (between 18 to 25 months).

Eligibility Criteria:
Inclusion Criteria:

* Must have age ≥ 18 years old;
* diagnosis of HIV/AIDS;
* use of antiretroviral therapy;
* Must have lymphocyte T CD4+ cell count ≥ 350 cel/mm3
* Must have physical fitness by the assistant physician.

Exclusion Criteria:

* pregnancy;
* severe hearing deficiency.
Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison

The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice.

This is a single center, prospective, non-blinded clinical investigation enrolling consecutive patients with coronary lesion candidate for FFR assessment. The study aim to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1, n=30). In addition, The investigators will compare (group 2, n=15) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice. The clinical investigation will be conducted in the Centre Hospitalier de l'Université de Montréal (CHUM). No clinical follow-up is requested after the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Single de novo coronary lesion or in-stent restenosis lesion with an operator assessed reference diameter ≥2.0 mm requiring FFR measurement based on the operator's clinical judgment

Exclusion Criteria:

* Patients with ST-segment-elevation myocardial infarction (STEMI), culprit lesion of non-ST-segment-elevation myocardial infarction (NSTEMI), New York Heart Association class IV heart failure, suspected or visible thrombus, dissection or excessive calcification or tortuosity in the target vessel, or a stenosis in a bypass graft will be excluded.
REDUCE LAP-HF III Corvia Protocol 1701

This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.


Eligibility Criteria:
This is a post market registry so no criteria requirements (only recommendations).
Effect of Standard Laryngoscopy Versus Video-laryngoscopy

The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated:

1. Conventional intubation with hyperangulated videolaryngoscope (control group),
2. Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope,
3. Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.

Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management.

The investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective surgery requiring oral tracheal intubation;
* ≥18 years of age;
* simplified Arné score ≥11;
* Written informed consent will be obtained from every participant.

Exclusion Criteria:

* ≤18 years of age
* interincisor distance at maximal mouth opening ≤2 cm;
* planned awake fiberoptic intubation because patients are patients considered to be high-risk for difficult intubation or difficult mask ventilation (e.g. with neck tumours, complete cervical arthrodesis; neck circumference \>50 cm);
* patients at risk of gastric aspiration
* planned nasal intubation.
Racial Differences in Yoga-Induced Responses

The purpose of this study is to 1) determine whether racial differences are evident in resting arterial stiffness and ambulatory blood pressure between African Americans and Caucasians 2) compare heart rate, blood pressure and cytokine production responses to exercise (yoga) between African Americans and Caucasians; 3) compare isokinetic muscular strength between racial groups; and 4) determine if correlations exist between these measures.


Eligibility Criteria:
Inclusion Criteria:

* Men between the ages of 18 and 39 (25 African American and 25 Caucasian) that are not professional or collegiate athletes
* Must exercise at least 3 days per week and have no more than 1 month of yoga practice.

Exclusion Criteria:

* Having stage 2 hypertension (\>130 mmHg for systolic / \>90 mmHg for diastolic) or higher or having taken BP medications within the 3 months prior to testing
* Infection within the previous 4 weeks
* Known renal disease
* Prior myocardial infarction
* Known coronary artery disease
* Personal history of stroke
* Heart failure
* Cardiac arrhythmias
* Chronic obstructive pulmonary disease
* Recent chest pain or dyspnea
* Orthopedic limitations that preclude the execution of yoga postures
* Current insulin dependence
* Chronic inflammatory conditions
* Blindness or deafness as participants will need to follow a yoga DVD in order to complete the session
* Having practiced yoga for more than 1 month
* Having parents of mixed racial backgrounds (i.e. both parents must be Caucasian or African American)
* Not being African American or Caucasian
* Being a professional or collegiate athlete
* Being insulin-dependent
Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who give written consent to participate in the study and for the transfer of material for cellular and molecular studies.
* Understand the purpose of the study and to be available to perform the procedures written in the protocol.
* Any child of 1 day old to 18 years old, admitted to the Paediatric Intensive Care Unit due to severe acute heart failure of any etiology.

Exclusion Criteria:

All patients who

* express their wish of not to participate in the protocol
* have hypertrophic or restrictive cardiomyopathy
* have aortic Stenosis
* have a known allergy to any drug used in the study
* it is not possible to prescribe the study medication because it is contraindicated according to the Summary of the Product Characteristic or according to the criteria of the physician responsible for patient
* are pregnant
Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day period. "Radiolabelled" means that the test drug has a radioactive component to help us track the drug. The safety and tolerability of the test drug will also be assessed.


Eligibility Criteria:
Inclusion criteria:

* Healthy males, aged 30-55 years inclusive.
* Body weight more or equal to 50kg with a BMI (body mass index) between 18.5-29.9kg/m2 inclusive.
* Healthy as based on a medical evaluation consisting of medical history, physical examination, lab tests on blood and urine and cardiovascular monitoring.

LH, FSH and testosterone hormones must be within normal reference range.

Exclusion criteria:

* Positive urine drug screen or alcohol breath test at screening visit.
* Average weekly alcohol intake of more than 21 units or average daily intake of more than 3 units.
* Grapefruit or grapefruit juice intake 7 days before dosing and until the last blood sample is taken.
* Any subject who is not prepared to eat standard meals in the clinic or is a vegetarian.
* Participated in a clinical trial for a new drug within 30 days or 5 half-lives or twice the duration of that drugs effect before the dosing day for this study.
* Exposure to 4 new drugs in clinical trials within the last 12 months before dosing in this study.
* Use of any medications (prescribed or non-prescribed including vitamins and herbal supplements) within 7 days before dosing in this study.
* Participation in this study would result in the subject donating more than 500ml in a 56 day period.
* Regular use of tobacco or nicotine-containing products within 6 months of screening.
* Unwillingness to abstain from sexual intercourse with pregnant or lactating women from dosing until 84 days after.
* Unwillingness to use contraception and have female partner use contraception if she could become pregnant for 84 days after dosing.
* Unwillingness to abstain from strenuous physical activity for 48 hours before screening and in the 72 hours before and 48 hours after the treatment period.
* Administration of radiolabelled substances or exposure to significant radiation (eg serial X-rays or CT scans, barium meal etc)within the past 12 months from screening.
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written and dated informed consent
* BMI between 19 and 30 kg/m2
* Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

* History of any clinically significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Laboratory blood sample result showing elevated liver enzymes (ASAT, ALAT) and muscle enzymes (CK).
99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy

An open-label, single center study with 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.

none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age;
2. Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;
3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;
4. In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;
5. Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient;
6. Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression;
7. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 109/L
   * Hemoglobin: \> 80 g/L
   * Platelets: \> 50.0 x 109/L
   * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
8. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination;
9. Subject is capable to undergo the diagnostic investigations to be performed in the study;
10. Informed consent

Exclusion Criteria:

1. Second, non-breast malignancy
2. Active current autoimmune disease or history of autoimmune disease
3. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
4. Administration of other investigational medicinal product within 30 days of screening
5. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.

The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.

The secondary objectives are:

* To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,
* To explore the contribution of the adaptive immune response in the persistent activation of the immune response,
* To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,
* To establish a correlation between the pathology and the physio-pathology of TBI.


Eligibility Criteria:
Inclusion Criteria:

1. patient ≥ 18 years old at the time of inclusion
2. Written and informed consent obtained from the family / proxy
3. Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission
4. Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization
5. Absence of contraindications to perform an MRI
6. Patient affiliated to a social security scheme (free State medical aid excluded)

Exclusion Criteria:

1. Patient under protection of the law (guardianship or tutorship)
2. TBI of ballistic origin
3. Pregnant woman
4. Pre-existing cerebral disease that can bias the MRI scan evaluation
5. Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)
6. Patient with severe impairment of vital and / or life-threatening function with disability prior TBI
7. Neurological antecedent susceptible to interfere with clinical evolution at one year
8. Severe cardiogenic shock
9. Severe respiratory impairment
10. Extra-brain injuries involving immediate life-threatening
11. Hemoglobin level below 9g / dL
Study of Clinical Outcomes of Thyroid Cancer

The Italian Thyroid Cancer Observatory (ITCO) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation.

Little information is available on current practices in the treatment of thyroid cancer: a web-based thyroid cancer database was created to collect real-life data. The participants' network include tertiary referral centers operating at the national level, as well as smaller hospital-based units with local or regional recruitment areas.

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed thyroid cancer
* clinical follow-up including serum thyroglobulin (Tg) assays, circulating Tg antibodies, and high-resolution gray-scale and color Doppler US of the thyroid bed and cervical lymph node compartments. Additional imaging studies and/or fine-needle aspiration biopsy for cytology are ordered at the examiner's discretion in accordance with evidence-based guidelines
* entire follow-up at a participating clinical center.

Exclusion Criteria:

* patients referred to the recruiting centers ≥12 months from the primary treatment