cyrilzakka/clinical-trials huggingface dataset:
EASYTRAK 4 Steerable LV Lead

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

Eligibility Criteria:
Inclusion Criteria:

* Must receive a commercially available Guidant CRT-P or CRT-D device
* Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
* Geographically stable residents who are available for follow-up

Exclusion Criteria:

* Have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate
* Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
* Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
* Currently requiring dialysis
* Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
* Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
* Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
* Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
* Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
* Have a mechanical tricuspid heart valve
* Women who are pregnant or plan to become pregnant Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony. Myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (CD). It has been proven that exposure to oxytocin during labor results in a decrease in myometrial contractions.

Dexmedetomidine is a drug which has been used in obstetric practice due to its desirable effects such as decreasing pain, reduced elevation in blood pressure and heart rate, sedation, and diminished anesthetic requirement. It has been used as an adjunct during spinal or epidural anesthesia during CD and even during general anesthesia for some obstetric surgeries.

The use of dexmedetomidine has been continuously rising due to its favorable effects. Its use as an adjunct in general anesthesia for obstetrical surgeries has been shown to have promising advantages. During this pandemic, dexmedetomidine has been utilized largely as a sedative in critically ill and intubated patients. This does not exclude critically ill pregnant patients who may also need to deliver urgently. Thus, it is important to investigate its effect on uterine contractility on this particular group of patients.

The investigators hypothesize that dexmedetomidine causes a dose-dependent increase in contractility of the pregnant human myometrium, both spontaneous and oxytocin-induced.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients scheduled for elective CD under regional anesthesia at 37-41 weeks of gestational age will be included in this study.
* Only patients for primary CD or repeat CD (1x) will be included in this study since excessive uterine scarring from multiple CD may affect the contractility of myometrial sample.

Exclusion Criteria:

* patient refusal
* emergency CD
* general anesthesia
* placenta accreta spectrum disorder
* any condition predisposing the patient to uterine atony (e.g. polyhydramnios, multiple gestation)
* patients taking medications affecting myometrial contractions(labetalol, magnesium etc.).
Peripheral Metabolic Effects of Ghrelin

The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.


Eligibility Criteria:
Inclusion Criteria:

1. BMI \< 27 kg/m2
2. Written informed consent
3. Non-smoker

Exclusion Criteria:

1. Any disease including epilepsy
2. Any use of medications (excl. paracetamol)
3. Present or previous malignancy
4. Alcohol dependency
5. Allergy to any trial medication
Influence of Square-stepping Exercise on Brain Activation, Cognitive Function and Physical Performance in Frail Elders With MCI

This study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.

Background:

Both frailty and MCI exert negative impact on motor and cognitive function, which increase the risks of fall and adverse health condition. SSE has been proved to be an effective intervention for motor and cognitive function in older adults. However, the underlying mechanisms of SSE still remain undetermined for its possible effects. This study aims to elucidate the possible mechanisms of SSE in frail elders with MCI.

Methods:

This is a cross-sectional study. The inclusion criteria are: (1) age between 65 and 90 years old, (2) the presence of at least 1 characteristic of the Fried frailty criteria, (3) with mini-mental state examination (MMSE) score≧24 and Montreal Cognitive Assessment (MoCA) score \<26 (MCI criteria), and (4) ability to walk independently for 1 min without assistive devices. The exclusion criteria are: (1) central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury), and (2) any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study. Brain activity during SSE and usual walking, SSE performance, physical performance, and cognitive function are measured. The purpose of this study is to elucidate the possible mechanisms of SSE by examining brain activation differences between SSE patterns and usual walking, as well as the relationship between brain activity and SSE performance, between cognitive function and SSE performance, and between physical performance and SSE performance in frail elders with MCI.

Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 90 years old
* Presence of at least 1 characteristic of the Fried frailty criteria
* Mini-mental state examination score equal to or more than 24
* Montreal Cognitive Assessment score less than 26
* Ability to walk independently for 1 min without assistive devices

Exclusion Criteria:

* Central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury)
* Any unstable physical condition, psychiatric disorder, and other neurological disorder or diagnosed with learning disability which may affect participating this study
Combination Chemotherapy With Pazopanib in Children and Adolescents With Relapsed/Refractory Solid Tumors

The purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with Pazopanib in pediatric patients with relapsed/refractory solid tumor


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory/relapsed solid tumor (Stable or progressive disease after 1st-line treatment or relapse)
* Patients previously enrolled to "Genomic diagnosis of pediatric tumors by NGS (IRB No. SMC 2015-11-053)"

Exclusion Criteria:

* Patients who had high-dose chemotherapy and autologous stem cell transplantation previously
* Patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (ULN), ejection fraction \<40%, significant arrhythmia or conduction disturbance)
* Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
* Patients with active bleeding
* Patients who are taking strong CYP3A4 inhibitors, QTc-prolonging drugs, antithrombotic agents, or anti-platelet agents
* Pregnant or nursing women
* Patients who can not swallow the pill
An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses

This study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("AKs") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with fluorouracil cream to the face.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

INCLUSION CRITERIA:

* Patients must give written informed consent;
* Patients must have at least 5 visible and/or palpable AKs on the posterior scalp, ears, neck, lips, arms and/or hands (across all other body sites) and an additional 5 visible and/or palpable AKs on the face (including anterior scalp, if applicable);
* Female patients must be post-menopausal for at least one year, or have had a hysterectomy, or have had a tubal ligation, or use oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first application of test medication
* Patients must be compliant and willing to return to the study site for designated follow-up visits.

EXCLUSION CRITERIA:

* Pregnant or lactating females;
* Patients with a current skin condition on the face, scalp, ears, neck, lips, arms and/or hands that could confound the study, including basal cell and squamous cell carcinomas;
* Patients with a known allergy to any ingredients of the test drug formulations;
* Patients with known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency;
* Patients whose activities involve excessive or prolonged exposure to sunlight;
* Patients who use a tanning parlor;
* Patients treated with other topical agents for the treatment of actinic keratosis in the designated treatment area within 5 months prior to the start of the study are prohibited;
* Patients who have had liquid nitrogen treatment for AKs within 4 weeks prior to study start in the designated treatment area;
* History of drug or alcohol abuse.
Multimodal Connectome Study of Brain Tumor-operated Patients

In this pilot study, the investigators propose a multimodal evaluation of the brain connectivity of brain tumor patients, in order to better understand the effects induced by focal lesions on brain structure and function, as well as brain plasticity mechanisms that may occur in such condition. The investigators aim at drawing a multimodal brain connectivity map of focally brain-damaged patients, with a view to improve onco-functional neurosurgical practices.

Patients included in the present study will first perform the pre-operative MRI (dMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional acquisition at rest. Then, the investigators will record their cortico-cortical evoked potentials elicited by direct electrostimulation during the surgery, just before the tumor removal, following our usual protocol. Finally, all data (clinical, diffusion, electrical and functional connectivity) will be processed and correlated to each other.

Eligibility Criteria:
Inclusion Criteria:

* All patients with brain tumor for removal
* Age \> 18 years
* Informed patient consent
* Membership of social security scheme

Exclusion Criteria:

* Contraindication to MRI
* Any subject with vascular stent implanted less than 6 weeks prior to the exam;
* Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures;
* Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects;
* Presence of more than one brain tumor
* Refusal of patient participation
* Pregnant or nursing women. A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
* Person staying in a health or social establishment
* Person in emergency situation
* Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be conducted in a randomized double-blinded fashion. This dose-response study will be conducted as per the up-down sequential allocation method, modified by the Narayana rule, designed to cluster the results around the ED95.

Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. Phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.Hypotension will be defined as a SBP less than 80 % of the baseline value, in which case the treatment will be a failure. Hypertension will be defined as a SBP more than 120 % of baseline value. If a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.

Eligibility Criteria:
Inclusion Criteria:

* Elective CS under spinal anesthesia
* Normal singleton pregnancy beyond 36 weeks gestation
* ASA physical status I/II
* Weight 50-100 kg, height 150-180 cm
* Age over 18 years

Exclusion Criteria:

* Patient refusal
* Allergy or hypersensitivity to phenylephrine
* Preexisting or pregnancy-induced hypertension
* Cardiovascular or cerebrovascular disease
* Fetal abnormalities
* History of diabetes, excluding gestational diabetes
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.


Eligibility Criteria:
Inclusion Criteria:

* Adult women greater than or equal to (≥) 18 years of age
* Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I to IIIC, including inflammatory and multicentric/multifocal breast cancer, with tumor size ≥1 centimeter (cm) by ultrasound or ≥2 cm by palpation, centrally confirmed HER2-positive (immunohistochemical score \[IHC\] 3+ or in situ hybridization \[ISH\]-positive)
* At least 1 measurable lesion in breast or lymph nodes (≥1 cm by ultrasound or ≥2 cm by palpation), except for inflammatory carcinoma (T4d)
* Baseline left ventricular ejection fraction (LVEF) ≥55%
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Adequate organ function at Baseline

Exclusion Criteria:

* History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
* Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
* Metastatic disease
* Any prior therapy with anthracyclines
* Prior anti-HER2 therapy or biologic or immunotherapy
* Serious cardiac illness
* Pregnant or lactating women
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

* pregnancy
Study of ABSORB Stent in Acute Myocardial Infarction

The aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR), thrombosis of the device in patients who are undergoing angioplasty in myocardial infarction and in which bioabsorbable stent was implanted (BVS). Additionally, we will evaluate the acute recoil after implantation of bioabsorbable stents. A 24 months follow-up , by means of coronary angiography accompanied by QCA and assessment with intracoronary ultrasound (IVUS) and VH (virtual histology) is scheduled.

The drug -eluting stents (drug eluting stents , DES) are currently used routinely in the course of coronary angioplasty ( percutaneous coronary intervention , PCI ) and have significantly reduced the incidence of adverse events during follow-up in the medium and long term .

However, the persistence of the metal structure of these devices within the coronary artery over time adds no additional benefit but , on the contrary , it is potentially harmful because it may predispose to coronary thrombosis even after years of implantation, can alter the structure of the vessel for remodeling phenomena, can decrease a coronary vasomotion and reducing the possibilily of a future surgery. The recent development of new devices such as bioabsorbable vascular scaffold " BVS " release of antiproliferative drug ( everolimus ), could provide new clinical advantages especially in patients who are revascularized during acute myocardial infarction. These patients are at higher risk of MACE and stent thrombosis late .

The aim of our study is to evaluate the clinical outcomes conventional to 30 days and 1 year, such as cardiac death, myocardial infarction, target lesion revascularization(TLR ), target vessel revascularization (TVR ), thrombosis of the device in patients who undergo angioplasty in the course of acute coronary syndrome and in which it was implanted bioabsorbable stent ( BVS ). The acute recoil after implantation of bioresorbable vascular scaffold will also be assessed Finally, a follow-up of 24 months we will conduct, by means of coronary angiography accompanied by QCA and IVUS with VH .

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years with acute coronary syndrome (STEMI and NSTEMI) will be enrolled

Exclusion Criteria:

* patients with these characteristics will be excluded: cardiogenic shock (defined as systolic blood pressure less than 80 mmHg for more than 30 minutes or the need for compressors or intravenous-intraaortic balloon counterpulsation), history of bleeding diathesis, history of leukopenia , thrombocytopenia, or severe hepatic or renal dysfunction, a non-cardiac disease associated with a life expectancy of less than one year, participating in another study, or not able to give informed consent due to a prolonged resuscitation cardiopulmonary.
Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

The purpose of this study is to assess HbA1c reduction after supportive care by SMS among adolescents with poorly controlled type 1 diabetes.

In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with 60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text message is one of the strategies to enhance adherence. The main aim of this study is to assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial. This study is a prospective randomized monocentric trial. Sixty adolescents with type 1 diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The patients will receive one SMS before each injection of insulin.

Eligibility Criteria:
Inclusion Criteria:

* aged between 12 and 21 years old
* with type 1 diabetes for more than 6 months
* HbA1c at enrollment \> 8.5%
* non-opposition of one of the parents
* previous medical exam (art. L.1121-11 du CSP)
* Possible follow-up for 6 months
* social welfare coverage
* Adolescents with a mobile phone, able to receive short text message

Exclusion Criteria:

* aged less than 12 or higher than 21 years old
* with HbA1c at enrollment \< 8.5%
* pregnancy
* psychiatric disease
* do not understand french