cyrilzakka/clinical-trials huggingface dataset:
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system with microbubble resonators. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-80 years old
* Histologically confirmed glioblastoma
* Planned for Carboplatin monotherapy
* Be willing and able to provided written informed consent/asent
* Tumor progression after first line chemo radiation
* Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
* Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
* Able to communicate verbally

Exclusion Criteria:

* Acute intracranial hemorrhage
* Ferrous metallic implanted objects in the skull or brain
* Prior toxicity with carboplatin chemotherapy
* Women who are pregnant or breastfeeding
* Cerebellar spinal cord or brain stem tumor
* Known active Hepatitis B or Hepatitis C or HIV
* Significant depression not adequately controlled
* Has previously received anti-VEGF or anti-VEGF agents like Avastin
* Cardiac disease or unstable hemodynamics
* Severe hypertension
* History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
* Active drug or alcohol use disorder
* Known sensitivity to gadolinium-based contrast agents
* Known sensitivity or contraindications to ultrasound contrast agent or perflutren
* Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices
* Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
* Severely impaired renal function
* Right to left or bi-directional cardiac shunt
* Cranial or systemic infection requiring antibiotics
* Known additional malignancy that is progression or require active treatment
Impact of Hand Osteoarthritis on Arterial Stiffness

Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
* Patients with radiographic hand OA defined according to the Kellgren
* Lawrence criteria (≥ 2).
* Steady dose of statins for at least one month.
* Subject affiliated to a social security scheme
* Written informed consent

Exclusion Criteria:

* Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
* History of arterial hypertension treated and / or uncontrolled (SBP \> 140 mmHg and DBP (diastolic blood pressure) \> 90 mmHg)
* Diabetes (fasting blood glucose \> 7 mmol/L)
* Obesity (BMI \> 35 kg/m²)
* Chronic renal failure defined by a glomerular filtration rate \<60 ml/min/1,73m ².
* Patient with uncontrolled cardiovascular disease or a personal history of cardiovascular events (myocardial infarction and angina, occlusive arterial disease, stroke)
* Pregnant or breastfeeding, or premenopausal and not taking an effective contraception
Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords. Indeed, the anatomy of the thyroid and its close location with the recurrent laryngeal nerve (responsible for the vocal cord movement) involves a possible lesion or inflammation of the nerve during the surgical procedure. This complication is common, affecting around 10% of thyroid or parathyroid patients following surgery. This complication can be reversible, with a speech therapy or a specific endoscopic treatment by an otolaryngologist.

Currently, a postoperative screening is performed by nasofibroscopy in the recovery room to directly visualize vocal cord mobility. This examination may be painful or badly tolerated by some patients.

Recent studies have highlighted the performance of ultrasound in this diagnosis. The protocol for these studies included an ultrasound distant of the intervention, while it is known that vocal cord paralysis may have earlier consequences.

In this study, the investigators would like to evaluate diagnostic performances of vocal cords ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

The main limitation of vocal cord ultrasound is mainly related to surgery. Surgery creates anatomical rearrangements, so the secondary objective of this study will be to test whether the preoperative visualization is predictive of a good postoperative visualization.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Scheduled surgery of total or partial thyroidectomy or parathyroidectomy
* Patient been informed and given his/her written consent to participate
* Patient affiliated to a social security scheme

Exclusion Criteria:

- Patient under tutorship or curatorship
Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies

This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.

This is a Phase I, open-label study consisting of a dose escalation phase in advanced solid malignancies to determine the maximum tolerated dose (MTD) of oral administration of MLN0128 in 1 or more dosing schedules, combined with paclitaxel on Days 1, 8 and 15 of each cycle, followed by an expansion phase for further safety and preliminary efficacy.

Once the MTD is determined for each of the dosing schedules evaluated, a dose and schedule will be selected for the expansion phase, which may enroll participants into 2 arms in parallel:

* Arm A will consist of HER2- unknown cancer participants receiving MLN0128+paclitaxel
* Arm B will consist of HER2+ cancer participants receiving MLN0128+paclitaxel plus weekly trastuzumab

Eligibility Criteria:
Inclusion Criteria:

* Voluntary written consent
* Locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ability to swallow oral medications
* For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 30 days following the last study drug administration
* Male participants must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration
* Clinical laboratory values as specified in the protocol
* For expansion phase (Arm A) - HER2-/unknown participants will be enrolled
* For expansion phase (Arm B) - HER2+ cancer participants will be enrolled

Exclusion Criteria:

* Diagnosis of primary brain tumor
* Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug
* Known impaired cardiac function or clinically significant cardiac disease
* Known treatment with systemic corticosteroid within one week prior to the first administration of study drug
* Diabetes mellitus
* Human immunodeficiency virus (HIV) infection
* Known active cardiovascular disease condition as specified in protocol
* Pregnancy (positive serum or urine pregnancy test) or breast feeding
* Malabsorption due to prior gastrointestinal (GI) surgery, GI disease
* Other clinically significant co-morbidities

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.

Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.

Eligibility Criteria:
Inclusion Criteria:

* Must be 4 years of age or older

  * Must have an active head lice infestation of at least 10 lice and viable nits
  * Agree not used any other pediculicides or medicated products during the study
  * Agree not to use a nit comb during the study
  * Must have a single place of residence

Exclusion Criteria:

* Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit

  * Used topical medication of any kind on the hair for a period of 48 hours prior to visit
  * Individuals receiving systemic, topical drugs or medications which may interfere with the study results
  * Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products
  * Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation
  * Females who are pregnant or nursing
Empiric Calcium in Massive Transfusion

Calcium helps blood to clot and thereby stop bleeding. Trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. The purpose of this study is to see if giving intravenous calcium immediately to patients who require large volume blood transfusion will decrease transfusion requirements, vasopressor use and mortality in bleeding trauma patients.

Advancements in the area of transfusion and blood product administration have occurred with the use of viscoelastic assays and whole blood. However, as we resuscitate trauma patients with blood products, hypocalcemia is an inadvertent side-effect. Citrate within stored blood binds calcium, causing patients to have hypocalcemia. In addition, outside of transfusion related hypocalcemia there is an independent trauma/inflammation related mechanism for hypocalcemia in the trauma patient. Furthermore, Calcium is a critical component of the coagulation cascade, and therefore a highly important component of hemostatic resuscitation. Hall et al found that patients receiving 13 or more units of PRBCs had a much higher prevalence of severe hypocalcemia and at least one ionized calcium \<1.0mmol/L. Kronstedt el al reported an association between hypocalcemia and mortality in trauma patients receiving massive transfusion. Despite evidence that hypocalcemia occurs with transfusion, and evidence that hypocalcemia in patients with hemorrhagic shock may be associated with increased mortality, there are no randomized controlled trials evaluating the administration of calcium in trauma resuscitation. Currently, the Joint Trauma System revised guidelines for damage control resuscitation from 2019 recommend administering 1g of calcium after the first unit of blood transfusion, and an additional 1g after no more than 4 units of blood administration. However, these recommendations are based on small cohort studies or retrospective studies. The purpose of this study is to evaluate the efficacy of early empiric intravenous calcium administration on transfusion requirements, vasopressor use and mortality in hemorrhaging trauma patients with initiation of a massive transfusion.

All trauma patients in which massive transfusion is initiated within 6 hours of arrival will be enrolled. Two study arms will be created, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. All critical trauma activations will get a baseline ionized calcium as part of their initial labs.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients receiving massive transfusion protocol

Exclusion Criteria:

* Pregnancy
* Prisoners
* Known history of hypercalcemia
* Active hyperparathyroidism
* Hemophilia
CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01

In cooperation with the molecular tumor board of the University Hospital Tübingen (UKT), a prospective collection of blood samples during the course of therapy is planned. It is a pilot study in which the technical feasibility of the approach (Highly Sensitive Next-Generation Sequencing (NGS) methods) initially should to be evaluated and further developed.

In this study, we would like to use and further develop Highly Sensitive Next-Generation Sequencing (NGS) methods. For this purpose, circulating cell-free nucleic acids (cell free desoxyribonucleic acid (cfDNA) or cell free ribonucleic acid (cfRNA)) are first isolated from the blood plasma. The circulating tumor desoxyribonucleic acid (ctDNA) and circulating tumor ribonucleic acid (ctRNA) fractions contained therein arise from the tumor tissue and can provide information about the existing tumor burden and the original tissue of the tumor. Somatic Single Nucleotide Variants (SNVs) and insertions and deletions (indels) serve as biomarkers within the ctDNA and ctRNA. The ctDNA also contains epigenetic information in the form of DNA methylation, which shows a characteristic pattern for each tissue. Informative regions of the genome can be specifically enriched using personalized or fixed NGS panels. In this way, an ultra-deep sequencing of defined regions can be carried out and even the smallest concentrations of ctDNA and ctRNA in liquid biopsies can be detected.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Advanced tumor disease
* Ability to consent
* Existence of a declaration of consent signed by the patient and physician (informed consent for study participation and Comprehensive Cancer Center (CCC) biobank
* Existence or planned implementation of tumor-normal sequencing (usually carried out in a diagnostic context upon presentation at the Molecular Tumor Board (MTB)

Exclusion Criteria:

- No therapy recommendation by MTB
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion Criteria:

* serious medical conditions
* allergies to vaccine components, including but not limited to egg/chicken products
* reduced immune function
* recent use of immunosuppressive therapy
* recent use of influenza vaccine
Does Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care

Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations.

In Ontario, audit and feedback (A\&F) is routinely offered to primary care providers from a variety of sources. Ontario Health - an agency created by the Government of Ontario - provides A\&F via email to physicians who voluntarily sign up for their "MyPractice" reports. These are multi-topic reports with aggregated (physician-level) data. As of November 2021, the MyPractice reports for family physicians will include data on antibiotic prescribing. To date, less than half of Ontario family physicians have signed up for the MyPractice reports from Ontario Health.

For this study, the investigators will conduct a trial to investigate the effect of adding viral prescription pad resources to family physician A\&F received through a MyPractice: Primary Care report. This evaluation provides an opportunity to determine if the addition of this resource to an A\&F intervention increases changes to antibiotic prescribing.

This study will examine ways to optimize the effects of A\&F for antibiotic prescribing in primary care. This study will aim to determine if emphasis (or not) on the use of a viral prescription pad developed by Choosing Wisely Canada (CWC) can help physicians act upon the feedback from their MyPractice report to reduce their antibiotic prescribing.

Antibiotic prescribing feedback within the multi-topic MyPractice: Primary Care report will be sent to family physicians who signed up for this program from Ontario Health. This report includes a link to the Choosing Wisely viral prescription pad. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive additional emphasis on the use of the viral prescription pad and will also have a paper copy of the prescription pad mailed to their practice.

One month after the initial intervention, participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. Intervention participants will also be invited to take part in a process evaluation interview.

Eligibility Criteria:
Inclusion Criteria:

* Family physicians who sign up for the MyPractice reports by September 2021

Exclusion Criteria:

* Family physicians who did not sign up for the MyPractice reports by September 2021
Dynamic Gait Analysis in Children With Mucopolysaccharidosis Type IVa

Mucopolysaccharidosis Type IVa (MPS IVa, Morquio Disease) is a rare inherited lysosomal storage disorder caused by deficiency of the enzyme galactose-6-sulfatase.

Children with this disease accumulate a chemical called keratan sulphate, which stops their skeletons developing properly. They are very short in stature and many of their joints are unstable. Children with MPS IVa walk in a different way to other people due to a combination of lax ligaments and skeletal problems such as knock-knees.

Human walking involves the coordinated movements of all four limbs. As we walk, the arms swing oppositely to the legs. This movement pattern is very different in children with MPS IVa. This change seems to involve the whole musculoskeletal system and depends on the severity of the disease.

Recent studies in children with MPS IVa describing walking pattern have concentrated solely on the lower or upper limb respectively, and have not looked at the interaction of the upper and lower limbs during walking.

To our knowledge, the mechanics of walking in children with MPS IVa has not been investigated using a dynamic gait analysis tool (using cameras, sensors and electrodes to track the movements of different parts of the body during walking) and we aim to characterise this in a small number of children with MPS IVa and also examine the effects of splinting the wrist upon the walking pattern to see if this simple intervention makes it easier or more difficult for children with MPS IVa to walk.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MPS IVa (documented history of reduced leucocyte GALNS enzyme activity relative to the normal range of the laboratory performing the assay AND/OR molecular analysis showing two pathogenic mutations in the GALNS gene)
* Willing and able to provide written assent and parent/legal guardian able to provide written informed consent after the nature of the study has been explained and prior to any research-related procedures
* Between 6 and 18 years of age inclusive
* Willing to perform all study procedures as far as physically possible

Exclusion Criteria:

* Inability to comply with Gait Analysis protocol (e.g. nonambulant)
* Recent orthopaedic surgery that investigator deems might impact on Gait Analysis
* Use of any investigational product or investigational medical device other than BMN110 within 30 days prior to recruitment, or requirement for any investigational agent other than BMN110 prior to completion of all scheduled study assessments
* Concurrent disease or condition that would interfere with study participation or safety
* Any condition that, in the view of the Principal or Subinvestigators, places the subject at high risk of not completing the study procedures
Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.

The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.

Eligibility Criteria:
Inclusion Criteria:

* Parent vessel diameter stenosis \> 75%
* Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
* The reference diameter of both branches more than 2.3 mm by visual estimation

Exclusion Criteria:

* Cardiogenic shock
* ST-elevation myocardial infarction within 48 hours of symptom onset
* Left ventricular dysfunction (echocardiographic left ventricular ejection fraction \< 25%)
* Graft vessels
* Patients who have to receive clopidogrel due to other conditions
* Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
* Hypersensitivity to clopidogrel or aspirin
* Expectant survival less than 1 year
* Women who plan to become pregnant
* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.