cyrilzakka/clinical-trials huggingface dataset:
SEDVasc (RaDiCo Cohort) (RaDiCo-SEDVasc)

The goal of this observational study is to describe the natural course of vascular Ehlers-Danlos syndrome, in particular the order of appearance of different types of complications (arterial, digestive, pulmonary and uterine).


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfil all of the following criteria:

* Patients (adults and children) with genetically-proven vEDS (presence of a pathogenic mutation at the COL3A1 gene);
* Patients (or his/her legal guardian) who does not oppose to his/her personal data collection.

There are no exclusion criteria for this study.
Absorptive Clearance in the Cystic Fibrosis Airway

The objective of this overall project is to develop a new aerosol-based technique for quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that abnormal absorption of ions from the airways causes excessive absorption of liquid, resulting in an airway surface liquid layer that is dehydrated and difficult to clear. Here we are measuring the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis patients and healthy controls. We hypothesize that the molecule will absorb more quickly in cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption is related to liquid absorption in the airways.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis subjects and healthy controls
* Age ≥ 18 years
* Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects)
* Clinically stable as determined by the investigator (pulmonologist)

Exclusion Criteria:

* Reactive airways disease
* Tobacco smokers (regular smoking within 6 months of enrollment)
* Positive urine pregnancy test on the day of testing
* FEV1p value of \< 50%
* SaO2 \< 92%, or if they require supplemental oxygen.
* Subjects performing other radioisotope studies within the last 2 weeks will be excluded.
* Healthy subjects with any history of lung disease will be excluded.
* Women currently breastfeeding
* Subjects not willing to stop treatments with inhaled hypertonic saline for 48 hours in advance of the study.
Peripheral for Quantify Strength of Children Functional During the Pinch Movement

This study has developed a peripheral to quantify the functional strength of children without motor change during the movement of grip and pinch. It was possible to know the exact values of these strengths, the range of motion that was made, and also if the grip strength was maintained during all the arc of motion.

Since childhood, it has been necessary to produce sufficient force to grip and pinch, for performing daily tasks independently; therefore, measurements of these forces end up being useful markers to evaluate the performance and the physical development of the child. It was developed a peripheral containing three devices and instrumented for analyzing the force applied during execution of the cylindrical grip movement, pinch pulp-side and pinch pulp-pulp in different situations of the daily life of the volunteer. The data acquisition interface was developed in a software for data recording. For the peripheral functionality tests, thirty volunteers of both genders were selected. They were also students of the Sports Secretary, with no motor abnormalities, between seven and ten years old.

Eligibility Criteria:
Inclusion Criteria:

* change Absence of skeletal muscle in the upper limbs
* neurological disorder Absence
* Informed Consent signed by the responsible
* with preserved cognitive.
* consent form signed by the volunteer

Exclusion Criteria:

* Having less than 7 years old
* Having more than 10 years old
* To present some compromise skeletal muscle in the upper limbs
* not take part in the research
QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced squamous NSCLC
* Measurable disease as defined per modified RECIST criteria
* ECOG performance status of 0 or 1
* ≥18 years old
* Adequate glycemic function, for subjects with known diabetes

Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)

Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years and 80 years of age.
2. The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
3. The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion Criteria:

1. Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
2. Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
3. The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
4. History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
5. Severe or malignant hypertension (= sitting SBP \> 180 mmHg and/or sitting DBP \> 105 mmHg)
6. The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
7. The patients who might die of other disease than cardiac disease during the trial.
Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.

In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and ACT measurements.

The primary objective of this study is to determine whether relative to patients with conventional management, those managed with the HMS Plus have improved thrombin generation after CPB.

The secondary objective is to determine if patients in the HMS Plus group have reduced blood loss in the first 24 hours following surgery compared with patients in the conventional group.

Cardiopulmonary bypass (CPB) allows cardiac surgery to be performed on a motionless, bloodless heart while maintaining circulation to the rest of the body. Anticoagulation with heparin prevents the body's clotting system from being activated when blood comes into contact with the walls of the bypass circuit. The amount of heparin given to achieve this effect is determined on a weight-based dosing and monitored with a point-of-care monitor called ACT (activated clotting time). However, there remains a high level of variability in the concentration of heparin in the blood and the ACT is affected by hypothermia and dilution of the blood, both of which commonly occur during CPB for cardiac surgery.

The Hemostasis Management System (HMS Plus) offers an alternative way of dosing and monitoring heparin by aiming to achieve a pre-determined heparin concentration throughout CPB, rather than being determined by the ACT. It also aims to determine the dose of protamine, the drug used to reverse heparin at the end CPB, required based on residual heparin concentration rather than on a 1:1 ratio of the total dose of heparin given which is the common current practice. The benefits of using this system are proposed to be more effective anticoagulation during CPB meaning less of the body's reserves of clotting factors are consumed. This could mean potentially less bleeding and decrease requirement of blood products following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo non-emergent coronary artery bypass grafting, valve repair or replacement (with or without ascending aortic replacement) or a combination of these procedures requiring the use of CPB

Exclusion Criteria:

* Less than 18 years old
* Planned use of deep hypothermic circulatory arrest
* Cases where use of brief circulatory arrest anticipated
* Highly complex cases (LVAD, Heart Transplant, Complex congenital)
* Significant liver dysfunction (liver enzymes \> 2-fold higher than upper limit of normal
* Pre-existing coagulopathy (INR \>1.5, PTT \>45 seconds, fibrinogen \< 1.0g/L, platelet count \<100x109/L)
* Use of long acting oral anticoagulants
* Patients on heparin infusions pre-operatively
* Major hemoglobinopathies, thalassemia or iron storage diseases
* Previous diagnosis of HIT
* Lack of informed consent
Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations

In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking.

The investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.


Eligibility Criteria:
Inclusion Criteria:

* patients of all ages
* patients that had undergone a modified Furlow palatoplasty
* patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary)

Exclusion Criteria:

* patients not eligible according to the abovementioned criteria
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)

The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.


Eligibility Criteria:
Inclusion Criteria:

* Woman of at least (\>=) 18 but not older than (\<= )40 years of age at the time of screening;
* Good physical and mental health;
* Regular cycles with a usual length between 24 and 35 days;
* Body mass index \>= 18 and \<= 35 kg/m\^2;
* Willing to give informed consent in writing.

Exclusion Criteria:

* Contraindications:

  * known or suspected pregnancy;
  * active venous thromboembolic disorder (e.g. deep vein thrombosis,

pulmonary embolism);

* presence or history of severe hepatic disease as long as liver function values have not returned to normal;
* malignancy or pre-malignancy, if sex-steroid-influenced;
* undiagnosed vaginal bleeding;
* hypersensitivity to any of the components of Radiopaque Implant.

  * Hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg;
  * A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss;
  * Present use or use during 2 months prior to the start of Radiopaque Implant of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort;
  * Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant
Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

Racial and ethnic disparities in obstetric anesthesia care remains persistent despite studies documenting its existence and calling for action. The goal of this study is to share disparity data with underserved minority groups being admitted to the labor and delivery unit for obstetric care, to reduce mistrust and misconceptions regarding obstetric anesthesia care, and to bridge the cultural gap between patient beliefs and safe anesthetic care and to empower patients through transparency and provide them with the information necessary to make informed decisions about their care, to improve health literacy, and to ultimately improve patient outcomes and satisfaction.

Patients admitted to Labor and Delivery Unit at MSH will self-identify race/ethnicity as part of the standard admission process (Documented in EPIC). Patients who elect for epidural placement for labor epidural analgesia will be approached by an Anesthesia Team Member to be enrolled in a minimal risk study. Participants who self-identify as a racial/ethnic underserved group (as defined by the NIH) will be randomized to receive routine care with a disparities discussion or routine care alone (in a Block Randomization format). Self-identified white participants will receive routine care and serve as a secondary comparison group. The disparities discussion will be performed following epidural placement when the patient is comfortable. During the postpartum period at patient follow-up (within 24hrs postpartum), an 18-point questionnaire evaluating outcomes and patient satisfaction will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital.
* Patients of age 18 or greater with a singleton fetus of at least 37 weeks of gestation that present in spontaneous labor, for induction of labor, or augmentation of labor.
* Patients in the first stage of labor and who have consented for placement of a labor epidural.

Exclusion Criteria:

* Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion,
* Patients who present with a coagulopathy or on anticoagulation medications that exclude them from receiving labor epidural analgesia,
* Patients who do not consent to labor epidural placement, or if they are on a mid-wife service.
* Patients that are converted to a cesarean delivery following trial of labor
Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial

The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors. Participants will complete three sessions over a seven-day period in a laboratory setting.

It is hypothesized that the combination of aerobic exercise and relaxation training could have additive effects on fatigue and related cognitive outcomes. Therefore, this study is designed to test the effects of exercise plus relaxation relative to aerobic exercise alone and relaxation training alone, over the course of three sessions within a seven day period. Participants will complete baseline and post-testing before and after the week of training, as well as pre- and post-testing at each session.

Participants will be randomized to one of three conditions:

1. Aerobic Exercise Only Condition (AERO) Participants randomized to the AERO condition will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate aerobic cycling on a stationary bike (50-70% age-predicted heart rate max). Each AERO session will end with a 20-minute quiet rest period.
2. Relaxation Only Condition (RELAX) Participants in the RELAX condition will complete three separate 20-minute sessions of relaxation training using a commercial neurofeedback device (headset \& smartphone app). Each RELAX session will end with a 20-minute quiet rest period.
3. Aerobic Exercise and Relaxation Training - Intervention Condition (COMBINED) Participants randomized to the COMBINED condition will complete three separate sessions comprised of 20 minutes of AERO exercise followed by 20 minutes of RELAX training.

All participants, regardless of condition will complete brief questionnaires assessing in-the-moment fatigue and affect, before and after each randomly assigned activity session. A larger survey and battery of cognitive tests will be completed at the beginning of the first appointment and at the conclusion of the third appointment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* previously diagnosed with breast cancer (ductal carcinoma in situ or stages I-IV)
* completed at least one cycle of chemotherapy treatment within the last 5 years
* must have reliable access to the internet
* must report at least one complaint concerning physical function, fatigue, memory, planning, thinking, negative mood, depressive symptoms, or anxiety
* must be capable of engaging in sustained stationary cycling at a moderate intensity

Exclusion Criteria:

* deaf in both ears
* unable to comfortably wear a pair of ear-bud headphones
* color-blind or do not have vision of at least 20/40 with the aid of contacts or glasses
* history or diagnosis of epilepsy
Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope

The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists physicians in the evaluation and management of patients with syncope.

Syncope is one of the more common presentations to the Emergency Department, representing between 1.2-1.5% of all evaluated patients and up to 6% of admissions. Due to an often broad and overlapping differential diagnosis, syncope represents a disease entity that often requires extensive workup. This typically involves laboratory tests, EKGs, x-rays, computed tomography, or other studies that are costly, time-consuming, and, in the case of diagnostic imaging, frequently involves ionizing radiation. Yet, despite extensive testing, an exact diagnosis is not made in up to 50% of cases.

Cardiac causes of syncope include myocardial infarction, pericardial effusion, volume depletion, arrhythmia, among other entities, many of which are life threatening. Echocardiography (cardiac ultrasound) has been used for inpatient syncope evaluations for several decades. In the Emergency Department, echocardiography is currently being used at the point-of-care (POC) in a limited and focused approach to a variety of conditions. However, POC ultrasound has never been systematically evaluated as a diagnostic or prognostic tool specifically for syncope in the Emergency Department. We aim to determine if an ultrasound-based protocol is effective as an adjunct in the evaluation of syncope. Our research study will examine the utility of POC ultrasound in the diagnosis, imaging and laboratory utilization, and prognosis of syncope in the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older presenting to the ED with acute syncope (defined as transient loss of consciousness) or near syncope (sensation of impending but not actual loss of consciousness) as a reason for ED visit.

Exclusion Criteria:

* persistent altered mental status
* alcohol or illicit drug-related loss of consciousness
* definite seizure, and transient loss of consciousness caused by head trauma.