cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a New System for Heart Rate and SpO2 Measurement.

Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or over.
* Patient affiliated to a social security scheme.
* Having received complete information on the organization of the research.
* Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
* Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
* Patient having carried out a preliminary clinical examination.

Exclusion Criteria:

* Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
* Person with tremors at the time of clinical examination (Parkinson, spasms...)
* People who cannot present the palms of both hands (amputation).
* Woman of childbearing age who does not have effective contraception.
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0-1.
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
* Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
* No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
* Adequate hematologic and organ function
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

Exclusion Criteria:

* Known central nervous system (CNS) disease.
* Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
* A history of bleeding, any serious bleeding events.
* Uncontrolled pleural effusion, pericardial effusion.
* Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
* History of interstitial pneumonitis.
* Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc.
* Prior allogeneic stem cell or solid organ transplantation.
* History of autoimmune disease
* Active hepatitis B or hepatitis C
* Pregnancy or lactation.
* Peripheral neuropathy grade ≥2.
* Participants with poor blood pressure control;
* Myocardial infarction incident within 6 months prior to randomisation;
* Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
* Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
Noninvasive Ventilation in Acute Myocardial Infarction

Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major cause of mortality and morbidity in the world. The myocardial ischemia is often the precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive pressure has been used as a therapeutic modality.

Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory and hemodynamic variables in patients with myocardial infarction.

Materials and methods: ten patients with acute myocardial infarction, with Killip I classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will be registered and electrocardiogram signals will be recorded for posterior analyses of HRV. Data will be collected before, during and after positive pressure ventilation.

Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed by Tukey test.

The patients will be recruited in Bonsucesso Federal Hospital with diagnosis of myocardial infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after the event.

Participation in the study protocol will be done according to eligibility criteria:

The study will be a randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with CPAP and Bilevel.

CPAP will be applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O. Bilevel will be applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.

Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction with Killip I classification, hemodynamic stability, between 24 and 72 hours post event;
* agreement to participate in the study, according written informed consent;
* 45 to 80 years old age.

Exclusion Criteria:

* unstable angina;
* systolic blood pressure \< 80 mmHg;
* patients who presented ST elevation \> 2 mm or with second-degree atrioventricular block;
* presence of pacemaker.
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy

To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values.

To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-75 years (inclusive)
* Patients with high-grade subarachnoid hemorrhage (WFNS 4-5)
* Decreased level of consciousness with the need for intracranial pressure monitoring
* Successful exclusion of the ruptured aneurysm with clipping or coiling
* Women of childbearing potential must have a negative serum pregnancy test
* Written informed consent obtained by a legal representative

Exclusion Criteria:

* Significant kidney and/or liver disease
* Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure \> NYHA II)
* Cerebrospinal fluid infection or signs of meningoencephalitis
* Acute respiratory distress syndrome (ARDS), pulmonary edema
* Preexisting coagulation disorder
* Patients with current alcohol or drug abusus or dependence
* Patients with a history of hypersensitivity against indocyanine green or sodium iodine
* Patients with thyroid disease causing hyperthyroidism
* Breast-feeding women
* Patients committed to an institution based on official directive or court order
Low Density Lipoprotein (LDL) Cholesterol Metabolism in Impaired Glucose Tolerance

Impaired glucose tolerance is associated with an increased risk of developing cardiovascular disease and atherosclerosis for reasons not yet totally understood. Previous studies evaluated the kinetics of plasma LDL and a faster removal rate of free cholesterol in normolipidemic patients with diagnosed arterial coronary disease and deposits of this cholesterol on the blood vessel walls. This disassociation of the cholesterol may suggest a new mechanism for not only the genesis but for the progression of arterial coronary disease. The objective of this research was to study the plasma kinetics of free cholesterol and cholesterol ester in impaired glucose tolerance patient, asymptomatic for coronary artery disease (CAD), to elucidate mechanisms involved in atherogenesis in these patients.

Along with hyperglycemia, the presence of obesity and dyslipidemia, risk factors associated with the natural onset of diabetes mellitus type 2, could possibly explain the high susceptibility of the glucose intolerance to cardiovascular disease. Dyslipidemia commonly linked to glucose intolerance is characterized by hypertriglyceridemia, low HDL-C and in spite of the LDL-C being apparently normal or slightly elevated, there is presence of small dense LDL. Formulated in the laboratory, an artificial lipid nanoemulsion marked with both 14C-cholesterol ester and 3H-cholesterol with lipid composition similar to LDL allows study the plasma kinetics of the two forms of cholesterol (free and esterified. The nanoemulsion mimics the natural LDL, but is prepared without protein. In contact with the bloodstream, the nanoemulsion acquires apolipoproteins, apo E preferentially, allowing it to be recognized and removed from plasma by LDL receptor. The application of this nanoemulsion was shown to be technically safe, appropriate and simple to be used in humans in order to understand the role of dyslipidemia in the atherogenic process.

Eligibility Criteria:
Inclusion Criteria:

* total cholesterol \< 6mmol/L
* LDL-C \< 4mmol/L
* triacylglycerides \< 2.2mmol/L
* with normal blood pressure or hypertension until 130/85 mmHg

Exclusion Criteria:

* presence of previous cardiovascular disease: macrovascular, peripheral arterial disease and cerebral stroke.
* presence of chronic disease: chronic renal failure (creatinin \>30 ug/mg), hepatic failure, asthma, chronic obstructive pulmonary disease, inflammatory disease, oncology and thyropathy compensated.
* use of drugs: statins, fibrates, glucocorticoids and metformin
Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Male or female with sickle cell disease
* Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months
* Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo

Exclusion Criteria:

* Calculated creatinine clearance less than 60 mL/min
* Current active dental problems
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants)
* History of cirrhosis or chronic symptomatic liver disease; acute liver disease
* History of aspirin-induced asthma
* History of allergy to zoledronic acid or similar chemical-entities
* Pregnant or nursing
* No prior bisphosphonate use
* Receipt of an investigational drug within 30 days
Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers

The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.

This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group, stratified by parity. No changes to in-person care will occur.

Mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum.

Mothers in the control group will receive no content messages.

Mothers will be recruited both antenatally and postnatally through social media and study posters. All recruitment and participant engagement will occur remotely via text message. Women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. If determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will only receive reminder texts to complete the follow-up surveys. Both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum.

The investigators aim to recruitment 140 participants in total, 70 per group.

Eligibility Criteria:
Inclusion Criteria:

To enroll antenatally, participants must:

* be at least 37 weeks pregnant
* have daily access to a mobile phone with text message capabilities
* are over 18 years of age
* speak and read English
* live in Nova Scotia, Canada.

To enroll postnatally, participants must:

* have an infant under 10 days of age
* have daily access to a mobile phone with text message capabilities
* are over 18 years of age
* speak and read English
* live in Nova Scotia, Canada.

Exclusion Criteria:

* newborn die or are expected to die prior to leaving the hospital
* they have no access to mobile phone, either personal or shared
* unwilling to receive text messages
* decline or withdraw to participate
* participated in Phase I of this project.
Eliglustat on Gaucher Disease Type IIIB

Evaluation of the safety in the combination usage of Cerdelga and Cerezyme in type III Gaucher disease patients and the efficacy on soft tissue diseases.

* This is a 3-year study and the enrollment time of this study is 24 months.
* The participants have to receive the investigational agent:Cerdelga.(Cerdelga have 21 mg、42 mg and 84 mg capsule.)
* The participants have to go back to the hospital and receive the investigational agent and take the Gaucher related biomarkers test before receiving Cerdelga, and 2 weeks, 1, 3, 6, 12, 18 and 24 months after receiving Cerdelga.
* The participants have to inform if any adverse events happened.
* The investigators will follow up by phone if adverse events happened in the participants after one months start the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Gaucher disease patients diagnosed by low B-glucocerebrosidase deficiency and GBA mutation .
* The participant is at least 6 years old at time of enrollment.
* Under stable Cerezyme dosage for at least for 3 months.
* Presence of lymphadenopathy.
* Patient (and/or their parent/legal guardian) is willing to participate and able to provide signed informed consent.

Exclusion Criteria:

* The participant is CYP2D6 ultra-rapid metabolizer.
* The participant had received substrate reduction therapy for Gaucher disease within 3 months of enrollment.
* The participant had any clinically significant disease other than GD, including cardiovascular (especially arrhythmia), renal, liver, pulmonary, endocrinopathy, hypokalemia, or hypomagnesemia that may confound the study result.
* The participant is pregnant or lactating.
* The participant is known to be allergy to Cerdelga.
* The participant use drugs that will strongly inhibit CYP2D6 or CYP3A activity .
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants
* less than or equal to 32 weeks of gestational age
* appropriate for gestational age
* enterally fed with infant formula
Effect of Rheumatic Heart Disease on Maternal and Fetal Outcomes

It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females between corrected and uncorrected rheumatic valve lesions

Heart disease is one of the most important medical complications during pregnancy as it is one of the common, indirect obstetric causes of maternal death. Approximately 1% of pregnancies are complicated by cardiac disease .

Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a chronic acquired heart disorder resulting from acute rheumatic fever. In developing countries, RHD continues to be a major cause of cardiac morbidity and mortality especially among young adult females In pregnancies complicated with cardiac disorders, maternal and perinatal mortality and morbidity depend on the type of disorder, the functional status of the patient and the complications associated with the pregnancy.

Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease, remains the most common acquired valvular lesion in pregnant women and the most common cause of maternal death from cardiac causes .

Although mortality is not high in women, the rate of fetal morbidity rises with the severity of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area \<1.5 CM2).

In the second and third trimesters, when maternal blood volume and cardiac output peak, heart failure may occur in pregnant women with moderate or severe mitral stenosis, even in previously asymptomatic women .

The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%, fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).

The advancement in cardiology and obstetrics has provided major improvements in the management of pregnant patients with cardiac disorders. Now we are facing more women with previous history of surgical correction of rheumatic heart disease.

Vaginal delivery is considered In women with mild mitral stenosis, and in patients with moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class III-IV symptoms, or who have pulmonary hypertension despite medical therapy.

Therapeutic options for in women with rheumatic heart disease include both medical and surgical alternatives, as well as catheter-based interventions The choice dependent on the degree of valvular affection and patient symptoms. There are few studies that compare the Maternal and fetal outcomes in women with rheumatic heart disease between patient with corrected and uncorrected valve lesions

Eligibility Criteria:
Inclusion Criteria:

* pregnant females with rheumatic heart disease

Exclusion Criteria:

* other heart diseases ( cardiomyopathy , myocardial infarction ...etc.
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.

Objectives:

The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.

Primary Aim:

To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.

Secondary Aims:

a) To identify and phenotype "non-responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP).

Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care.

Methods:

All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions.

Study Design: Single center, randomized pre-post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).

Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.

Eligibility Criteria:
* Inclusion Criteria:
* Female patient 18 years of age or older
* diagnosis of Interstitial Cystitis/Painful Bladder Syndrome, scoring 6 points or higher on O'Leary Sant Questionnaire
* Exclusion Criteria:

Active pelvic or bladder infection within past 2 weeks

* contraindications to medications or intervention therapeutics
* inability to speak or read English
* pelvic floor interventional procedure including bladder instillations 4 weeks prior to study recruitment
* meets criteria for diagnostic laparoscopy
* internal referral (to reduce severity bias)

Note: patients are not excluded for currently taking any medication on the treatment list.

Patients can be treated for UTI during the study period.