cyrilzakka/clinical-trials huggingface dataset:
To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing

To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at screening following spot urinary collection for Cohort 2.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients

The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients

Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males.

This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)

Eligibility Criteria:
Inclusion Criteria:

* Male
* Written informed consent
* ASA 1-3
* No relevant allergies
* Body-mass index (BMI) 20-35
* Age 16-85
* Non-urgent surgery of planned duration 0.25-4 hrs

Exclusion Criteria:

* Inability of patient/parent to understand or consent for the trial
* Neck pathology
* Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days)
* BMI \> 35
* Predicted or previously documented difficult airway
* Increased risk for Gastric Aspiration
* Current participation in another Clinical Study
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection.

ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth. However, ZDV has been given to very few premature babies, and the best dose to use has not yet been determined.

In the preliminary group of premature infants, those receiving q 6h dosing had an average trough concentration of 7.3 uM (18%). However, the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity. Due to the potential for altered ZDV pharmacokinetics and increased toxicity in this population, an evaluation of ZDV pharmacokinetics in premature infants is proposed.

Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life. Upon entry, ZDV will be administered every 12 hours intravenously or orally. The study will require 9 serum samples for ZDV assay collected over 30 days, some additional clinical laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection of routine clinical data.

Eligibility Criteria:
Inclusion Criteria

Your baby may be eligible for this study if he/she:

* Requires ZDV (as decided by your doctor) because you are HIV-positive.
* Is 1-5 days old and was born prematurely.

Exclusion Criteria

Your baby will not be eligible for this study if he/she:

* Is not expected to live 6 weeks because of severe illness.
* Is having problems with blood pressure or is not urinating enough.
Evaluating Auscul-X, a Touch Free Digital Stethoscope

Auscul-X a touch free digital stethoscope will permit physical distancing of healthcare providers while maintaining the ability to auscultate patients from a safe distance (over 10 feet away)

The Auscul-X System (AusculSciences Canada, Inc.), is novel, professional grade, touch free, multichannel, touch-free electronic stethoscope with disposable elements designed to protect HCPs from exposure to infection diseases by allowing them to auscultate patients from a safe distance (10 feet away). The sensors can stay in place and enable providers to listen on-demand to a patient's heart and lungs over an extended period of time. This practice of distancing in the workplace is a key CDC and PHAC recommendation to protect the frontline HCP from exposure risk to the highly contagious COVID- 19 virus and other communicable diseases. The Auscul-X not only has the potential to better protect HCPs from infection, but also eliminates the potential transmission of pathogens through the use of conventional stethoscopes. In addition, the Auscul-X allows multiple HCPs to listen to the patient's heart and lung sounds simultaneously

Eligibility Criteria:
Inclusion Criteria:

* \>/=18 years old
* Admitted to ICCU and CSICU at UOHI

Exclusion Criteria:

* Age \< 18 years old
* Medically Unstable
* Chest wall deformity or wounds in adhesive application areas
* Unwillingness or inability to provide Informed Consent or to comply with protocol
Measurements of Myocardial Relaxation Time by MRI During Respiration

Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.

This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.

The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.

The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.


Eligibility Criteria:
Inclusion Criteria:

* To have had a heart transplant, whenever
* To have an MRI scan of heart with measurement of T2 relaxation time (whatever the reason for examination)
* Major
* To be aware and cooperative
* Affiliation to social security plan
* To have given written consent after having received oral and written, clear and intelligible information

Exclusion Criteria:

* All contraindications to MRI (implantable defibrillator, cochlear implant, neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis installed since less than 4 weeks, osteosynthesis materials installed since less than 6 weeks...)
* Instable hemodynamic status, acute respiratory failure, uncertain general status or necessity of continuous monitoring incompatible with MRI examination
* Minors or being under juridical protection or absence of social security
* Refusal or impossibility of informed consent of patient
The NOR-SWITCH Study

The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
2. Male or non-pregnant, non-nursing female
3. \>18 years of age at screening
4. Stable treatment with innovator infliximab (Remicade) during the last 6 months
5. Subject capable of understanding and signing an informed consent form
6. Provision of written informed consent

Exclusion Criteria:

1. Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases
2. Change of major co-medication during the last 2 months prior to randomization:

   RA, SpA and PsA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease.

   UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication which according to the investigator would interfere with the stability of the disease Psoriasis: Initiation of synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease
3. Inadequate birth control, pregnancy, and/or breastfeeding
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
5. Change in treatment with innovator infliximab (Remicade) during the last 6 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects

The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.


Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent before any assessment is performed
* Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments
* ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits
* Weighs at least 50 kg
* Is able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms

This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, ≥18 years of age
* Positive stool culture for at least one of these three organisms: VRE, ESBLE or CRE
* Be willing and able to give informed consent
* If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in phase and willing to remain consistent throughout the study
* If subject is female: subject is surgically sterile or post-menopausal (12 months with no menses without an alternate medical cause); or if subject is a female of childbearing potential, must have a negative urine pregnancy test at Screening, must not be lactating, and must agree to abstain from sexual activity or agree to use one highly effective method of contraception for the duration of the study

Exclusion Criteria:

* Planned escalation of immunosuppression
* Neutropenia (≤500 absolute neutrophil count per μL)
* Allogenic stem cell transplant recipients with ongoing gastrointestinal disease
* Rapidly progressive or terminal illness
* Hemodynamic instability, or any other significant systemic, unstable or untreated disease
* Currently receiving or anticipated to require systemic (oral or IV anti-infective) or gut-directed antibacterial therapy
* Recent history of the following conditions requiring medical attention: known or suspected gastrointestinal (GI) infection (e.g., viral or bacterial gastroenteritis) or inflammatory bowel disease
* Major intra-abdominal surgery related to the bowel within the 3 months prior to Run-In
* Receiving total parenteral nutrition
* Contraindications, sensitivity, or known allergy to the use of the study product or its components
* Individuals who, in the opinion of the Investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures (e.g., planned procedures)
Neurocognitive Performance During Space Flight. Validation of a Test Battery

The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Persons with prior serious injuries to their head
* Persons who take any medication or drugs influencing their central nervous system or cognitive performance
* Pregnant women
Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of normal tension glaucoma.
* Indicated for filtration surgery using Ex-PRESS®.
* Understand and provide Informed Consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women who are pregnant, lactating, or planning to be pregnant during the study period.
* Diagnosis of angle closure glaucoma or secondary glaucoma.
* History of glaucoma surgery.
* Ophthalmologic surgery within the past 6 months.
* Difficulty with applanation tonometry measurement.
* Corneal dystrophy.
* Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
* Severe blepharitis or dry eye.
* History of metal allergy.
* Other protocol-defined exclusion criteria may apply.
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint

Various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. However, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. Failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies.

Due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/2025.
2. Patients aged between 12 and 35 years at the time of the surgical intervention.
3. Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
4. Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
5. Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Exclusion Criteria:

1. Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;
2. Patients who are no longer reachable;
3. Women of childbearing age who cannot exclude pregnancy;
4. Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Eligibility Criteria:
Patients will be studied if a disorder of the immune system is suspected.
Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2

To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* confirmed infection with SARS-CoV-2 (except for the controls)

Exclusion Criteria:

* n/a
Neurofeedback Training of Metacognition in Subjects With Alcohol Use Disorder. Disorder Induces Neural Modifications: an Event-related Potentials Study

Addressing cognitive deficits in alcohol use disorder (AUD) supports recovery. Impaired metacognitive functioning in AUD causes compromised recognition of the interoceptive state leading to the maintenance of alcohol abuse despite negative consequences. By promoting greater self-awareness and self-regulation, neurofeedback training is of high relevance in metacognition remediation to support abstinence.

The main objective of the present study is to validate neurofeedback as a complementary clinical tool to overcome metacognitive deficits that represent a significant factor in the maintenance of harmful consumption behavior and relapse phenomena in AUD.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years old undergoing a 3- to 4-week detoxification treatment program at the Alcohol Unit of CHU Brugmann hospital (Brussels, BELGIUM), who have been diagnosed with severe AUD (alcohol use disorder) according to the DSM-V-TR.

Exclusion Criteria:

* history of neurological disorders
* other serious medical conditions
* neuroleptic treatment are excluded.