cyrilzakka/clinical-trials huggingface dataset:
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

The aim of this study is to determine the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System under induced hypoxia, in terms of accuracy.

The study population includes 30 healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 to 50 years of age.
* Subject able to receive and understand information related to the study and give written informed consent.
* Subject is a non-smoker or an ex-smoker (stopped smoking for at least 6 months).
* Subject demographics include a range of dark skin pigmentations, including at least 30% of the total pool, assessed by phototypes V and VI according to the Fitzpatrick scale (Questionnaire score between 28 and 40).
* Subject is healthy (assessed by a physical examination AND normal ECG AND absence of medical treatment except for the birth control pill).
* Subject authorizing the treatment of their personal data collected during the study (box checked in the consent form).
* Subject affiliated to the French social security system.

Exclusion Criteria:

* Subject with antecedent of allergies to adhesives or silicone or a skin disease that would preclude the use of an adhesive.
* Subject with an implantable device such as a pacemaker.
* Pregnant or lactating women (assessed by a negative ß-HCG test).
* Subject with a high-altitude stay during the previous 4 weeks (more than 1 week spent over 3,500 meters).
* Subject with Raynaud's syndrome.
* Subject in exclusion period (determined by a previous or a current study).
* Subject under guardianship or trusteeship.
* Subject under the protection of justice.
Myotonometer Intra- and Inter Examiner Reliability on Spinal Muscular Atrophy

The primary aim of the study was to measure the intra-rater and inter-rater reliability of MyotonPRO in measuring postural muscle tone and mechanical properties in individuals with spinal muscular atrophy (SMA). The secondary aim is to question the existence of a relationship between the functional levels of individuals with SMA and their muscle tone and biomechanical properties. It is assumed that the outputs to be obtained from this research will form the norm data for moyotonometer evaluation in children with SMA.

It seems to be important to examine peripheral changes in the pathogenesis of SMA. Although it shows that the target center in SMA is alpha motor neurons located in the anterior horn of the spinal cord, considering the interaction network of interneurons, cerebellum, neuromuscular junction, gamma-alpha motor neuron pool, descending and ascending pathways, and reflex arc, it has potential to be investigated in individuals with SMA. This suggests that it may have important consequences for peripheral mechanisms. It may be important to examine muscle mechanical properties to reveal any potential correlations between SMA types and disease progression. In addition, moyotonometer results can be a key evaluation method in examining treatment efficacy, diagnosis and disease course. However, in order for these activities to be observed with myotonometer, first of all, the reliability of its use in individuals with SMA should be questioned.

Eligibility Criteria:
Inclusion Criteria:

* Between 0-4 years old
* Diagnosed with spinal muscular atrophy (SMA)
* Children who continue their medical treatment at home and are not in intensive care
* Children of families who agreed to participate in the study and approved the informed consent form.

Exclusion Criteria:

* Children of families who disagreed to participate in the study
Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults

The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL) value of portions of white bread containing 5 g available carbohydrate measured in this study is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods will be measured to determine their glycemic impact.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-75 inclusive
* Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days
* Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
* Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria at screening
* Pregnant or lactating individuals
* Personal history of diabetes
* Major trauma or surgical event within 3 months of screening
* The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator
* Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines
* Known intolerance, sensitivity, or allergy to any ingredients in the study test meals. All allergens should be assumed to be a result of manufacturing practices.
* Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.


Eligibility Criteria:
Inclusion Criteria:

* Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
* Wears lenses at least 5 days per week and at least 12 hours per day.
* Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
* Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
* Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
* Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently sleeping in contact lenses for more than 6 consecutive nights.
* Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
* Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds

The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities
* Male or female age \>= 6 and \<= 65 years of age
* Total burn wounds measuring \<= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts
* The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA)
* Females of child-bearing potential with a negative urine or serum pregnancy test on admission
* Able and willing to comply with the procedures required by the protocol

Exclusion Criteria:

* Conductive electrical burns and chemical burns
* Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
* Circumferential burns are excluded as a test area
* 4th or 5th degree burns
* Test area with infection as determined clinically by the Investigator prior to surgery
* Venous or arterial vascular disorder directly affecting a designated test area
* Known immune deficiency disorder, either congenital or acquired
* Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: Medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
* Severe respiratory problems or concurrent head trauma at hospital admission
* Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
* Known or newly diagnosed diabetics requiring insulin
* Any other acute or chronic concurrent medical condition(s) that in the Investigator's opinion are a contraindication to skin grafting and study participation
* Known or suspected hypersensitivity to bovine protein
* Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).
Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter

A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

The PERFECT Study is a prospective, multi-center, single arm, post-market clinical follow-up study.

The objective of this post-market clinical follow-up study is to assess the performance of the EMBOVAC Aspiration Catheter in the treatment of acute ischemic stroke in a real-world clinical setting.

The study will also report on clot characteristics and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years old.
2. Subject experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery
3. A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research
4. EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion
5. Pre-stroke mRS ≤ 1
6. NIHSS ≤ 30
7. Informed Consent has been provided by the subject or the subject's legally authorized representative.

Exclusion Criteria

1. Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements
2. All patients with severe hypertension on presentation. All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy
3. Known cerebral vasculitis.
4. Known cancer with life expectancy less than 12 months.
5. Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion.
6. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
7. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
8. Evidence of dissection in the extra or intracranial cerebral arteries.
9. Occlusions in multiple vessels.
10. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
11. Currently participating in an investigational clinical trial that may confound study endpoints.
CfDNA in Hereditary And High-risk Malignancies 2

The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes. If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. The study will compare cancer detection rates between those receiving the new blood test and those receiving standard care, assess if the test leads to earlier cancer diagnosis, and evaluate its impact on patient outcomes. The study will also use questionnaires and interviews to understand how patients feel about the blood test, its incorporation into routine medical care, and perceptions of the medical value of test results. This research could lead to more effective and less invasive cancer screening for high-risk individuals.

Through the CHARM Consortium (www.charmconsortium.ca), we have shown that cell-free DNA (cfDNA) profiling can enable more frequent cancer surveillance from readily accessible blood collections. We are now conducting a prospective, multi-center, randomized control trial of cfDNA testing of 1,000 HCS carriers from across Canada to 1) compare cancer detection rates with and without cfDNA testing, 2) assess cancer stage shift and clinical impact reducing mortality and morbidity cancers, and 3) assess impact of access to cfDNA results on patients' quality of life and psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of hereditary breast and ovarian cancer (HBOC), Lynch Syndrome (LS), Neurofibromatosis type I (NF1), Li-Fraumeni Syndrome (LFS), PALB2, and Hereditary Diffuse Gastric Cancer (HDGC), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome).
* Patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol.
* All patients must have signed and dated an informed consent form for this study.

Exclusion Criteria:

* Patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. If a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection.
* Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.
* Patients undergoing investigations for a clinical suspicion of cancer.
* Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines

In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone


Eligibility Criteria:
Inclusion Criteria:

* History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated for fluid overload. Should have participated in the double-blind phase of the EMPHASIS-HF trial

Exclusion Criteria:

* Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2.
Curcumin as a Novel Treatment to Improve Cognitive Dysfunction in Schizophrenia

The investigators propose to test whether curcumin nanoparticles will improve behavioral measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who are already receiving a stable dose of antipsychotic.

The investigators will use a formulation of curcumin with high bioavailability that possesses a pharmacokinetic profile expected to exert biological effects. Specifically, 36 subjects will be enrolled in the double-blind randomized controlled trial. They will be randomized to curcumin or placebo for 8 weeks. At baseline, and 4 and 8 weeks, subjects will receive assessments of neurocognition (e.g., processing speed, attention and vigilance, working memory, learning, reasoning and problem solving), social cognition, EEG biomarkers (e.g., visual cortical plasticity and mismatch negativity), a serum marker of neurogenesis (BDNF levels), and clinical symptoms (positive and negative symptoms). At weeks 2 and 6 subjects will return for additional safety (e.g., vitals, side effects, akathisia) and medication adherence assessments. Improvement on the primary outcome measure (MATRICS Consensus Cognitive Battery), as well as secondary outcome measures, will be compared between participants randomized to placebo versus curcumin. The results of this study will establish whether curcumin is a viable adjunctive agent for future larger clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of schizophrenia
* age 18 - 65 years
* understand spoken English sufficiently to comprehend testing procedures
* corrected vision of at least 20/30
* currently prescribed an antipsychotic medication

Exclusion Criteria:

* clinically significant neurological disease determined by medical history (e.g., epilepsy)
* history of serious head injury (i.e., loss of consciousness \> 1 hr., no neuropsychological sequelae, no cognitive rehabilitation post head injury)
* sedatives or benzodiazepines within 12 hrs of testing
* any psychiatric hospitalization within 3 months prior to study participation
* behaviors suggesting any potential danger to self or others within 6 months prior to study participation
* antipsychotic dose change more than 50% over the 3 months prior to study participation
* acute medical problems or untreated chronic medical conditions within 3 months prior to study participation
Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients

Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.

Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.

The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) \<70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
* Aged 18-50 years.
* Scheduled for abdominal surgery.

Exclusion Criteria:

* Patients with Forced expiratory volume1/forced vital capacity\<7.
* Uncontrolled cardiac, respiratory, hepatic or renal diseases.
* Allergy to the study drug