cyrilzakka/clinical-trials huggingface dataset:
PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided a written informed consent
2. Subject \>/= 18 years.
3. Patient affiliated to social security
4. Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
5. Subject eligible for percutaneous coronary intervention AND undergoing a chronical oral anticoagulant treatment OR undergoing any semi-urgent invasive or non cardiac surgical planned intervention with major bleeding risks
6. Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
7. De Novo coronary lesions: \>/= 50% - \<100%
8. Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
9. Target lesion length \</= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
10. Reference diameters targeted vessels \>/=2.5mm and \</= 4.0 mm (visual estimation or QCA)

Exclusion Criteria:

1. Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
2. Subject with a life expectancy less than 1 year
3. Vulnerable subject, protected by law, unable to give his/her consent
4. Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
5. Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
6. Subject under chronical oral anti-coagulant treatment (optionnal indication)
7. Subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (DAPT) for at least 3 weeks
8. In stent restenotic lesion
9. Target lesion on vessels with nominal diameter \< 2.5 mm
10. Target lesion is located in or supplied by an arterial or venous bypass graft
11. Chronical Total occlusion (CTO)
12. Angioplasty indication for STEMI
13. Patient with signs of cardiogenic shock
14. Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
15. "Staged procedure" \> 8 days after the initial angioplasty
16. Documented left ventricular ejection fraction (LVEF) \</= 30%
17. Target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc...)
18. Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers

This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.


Eligibility Criteria:
Inclusion Criteria:

* Have given a written, informed consent
* Be willing and able to follow all instructions
* A negative urine pregnancy test if female of childbearing potential

Exclusion Criteria:

* Known sensitivities to study medication or its components
* Any signs of an active infection
* Use of disallowed products during the period indicated prior to the enrollment or during the study
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.

Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).

Eligibility Criteria:
Inclusion Criteria:

* Self-identification as a staff member or patient who has had breast cancer in a participating practice

Exclusion Criteria:

* Unable to speak, understand and/or read English
* Unable to provide informed consent
Regulatory BCells in Systemic Lupus Erythematosus

Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .

In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .

Eligibility Criteria:
Inclusion Criteria:

* Clinical and laboratory Diagnosis of Systemic Lupus disease.
* Must be adult.

Exclusion Criteria:

* Patients with clinical atherosclerotic vascular disease
* pregnancy.
Inert Gas Rebreathing in Ventilated Patients

Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 80 years
* mechanically ventilated patient
* existing PiCCO arterial line

Exclusion Criteria:

* FiO2 \> 60% (fraction of inspired oxygen)
* PEEP \> 10 mmHg (positive end-expiratory pressure)
* SO2 \< 90% (oxygen saturation )
* Systolic blood pressure \< 90 mmHg
* Heart rate \> 150 bpm
* APRV (airway pressure release ventilation)
* ICD (implantable cardioverter defibrillator) / pace maker
* \[ Anaesthetic Conserving Device (Anaconda) \]
Neuroscience Pain Education in Patients with Chronic Low Back Pain

The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Volunteered to participate in the study.
* Patients with 18-65 years
* Had low back pain for at least 6 months,
* Reported pain severity of 5 or greater according to the numeric pain rating scale
* Used pregabalin and gabapentin derivatives,

Exclusion Criteria:

* Previous spine or lower extremity surgery
* Severe osteoporosis
* Spondyloarthropathy
* Spondylolisthesis
* Lumbar stenosis
* Systemic inflammatory diseases
Get in Shape in the Team Research: Porukalla Kuntoon Tutkimus

It is well accepted that physical activity in the form of resistance training produces a wide variety of neuromuscular-skeletal and health benefits. It is recommended in Finland that older individuals (over 65yr) should perform resistance training twice per week.

Unfortunately, only approx. 5% of older individuals fulfill this recommendation. As Finnish society grows ever older, research should focus on the specific needs of this group and how to improve participation in physical activity, which may ultimately lead to modification of physical activity recommendations - resistance training recommendations are currently the same for young and older adults and do not include specific recommendations on the type of resistance training. However, these recommendations appear to have been developed for "best possible" improvements in maximum strength and muscle size.

Therefore, it is of great importance to identify the number of resistance training sessions per week required to induce improvements in physical fitness, metabolic and bone health status, and importantly the reasons for adherence to/drop-out of resistance training interventions (e.g. motivation to train) in a multi-discipline study. This knowledge would benefit policy makers to update current recommendations for resistance training and to devise strategies to advise realistic targets for resistance training in the older, particularly the less-educated, age group (e.g. TELI-strategy for 2020).

The present study will include a 12-month resistance training intervention with a 12-month follow-up period. Interviews and questionnaires will assess psychological/sociological data and will be collected from both drop-out subjects and those that complete the intervention. Neuromuscular performance and functional capacity will be tested using conventional methods, along with body composition, bone density, and blood tests for metabolic markers of health. Diet and other physical activity will be controlled throughout the intervention period. Measurements are to be performed every 3 months.

It is expected that 5 international peer-reviewed articles will be published in 2016-2017. The data will be presented at international and national conferences in 2015-2017. Finally, results of the entire research will be published in national peer-reviewed journals (e.g. The Age Institute's "Raportteja"). All subjects will be invited to attend an information meeting where group results will be presented and explained.


Eligibility Criteria:
Inclusion Criteria:

* BMI\<37
* Does not smoke
* Able to perform all tests and exercises
* Free from episodes during physical activity

Exclusion Criteria:

* BMI\>37
* Use of waling aids
* Previous testosterone-altering treatment, e.g. in cancer treatment or hypogonadism
* Serious cardiovascular disease that may lead to complications during exercise
* Use of pharmaceuticals that affect neuromuscular or endocrine systems
* Regular endurance training\>3hr per week
* Resistance training experience
Normal Values for Myocardial Left Atrial Strain

Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.


Eligibility Criteria:
Inclusion Criteria:

* No history of cardiopathy / pneumopathy.
* No history of hypertension or mellitus diabetes.

Exclusion Criteria:

* Pregnancy.
* Athletes.
* Body mass index \< 16 or =\> 30 kg/m2.
* Previous treatment with cardiotoxic chemotherapy.
* Dilated left ventricle (telediastolic diameter index \> 30 mm/m2).
* Interventricular septal thickness =\> 12 mm.
* Dilated left atria (volume =\> 31 ml/m2).
* Systolic pulmonary pressure =\> 35 mmHg.
* Moderate or severe valvulopathy.
* Incomplete or suboptimal left atrial visualization.
* Frame rate \< 50 fps.
The SUCCEED Trial of Secondary Stroke Prevention

The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.

Individuals randomized to the intervention arm will receive care from a team that consists of a care manager(CM) who is either a nurse practitioner (NP) or physician assistant (PA), supervised by the site PI, and a community health worker (CHW). The CM will follow care protocols developed by the research team. The CHW will serve as a liaison between the patient and the health care system, and mobilize resources and system support to reduce social isolation and improve stroke risk factor control self-management, through a series of workshops and home visits. Intervention participants will receive home blood pressure monitors. Subjects in either arm are eligible to receive their usual source of care. Five hundred participants who have had a stroke or TIA will be enrolled, randomized to the intervention or to usual care in a 1:1 ratio, and followed for 12 months. The impact of the intervention on systolic blood pressure is the primary study outcome; secondary outcomes are other stroke risk factors. Enrollment will occur at four sites in Los Angeles County, and the study sample is projected to include over 90% socioeconomically disadvantaged individuals from minority groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Los Angeles County+University of Southern California (LAC-USC), Rancho Los Amigos, Olive View-University of California, Los Angeles (UCLA), or Harbor-UCLA
* Transient ischemic attack (TIA), ischemic stroke or hemorrhagic stroke within the prior 90 days
* English, Spanish, Korean, Mandarin or Cantonese-speaking
* 40 years of age or older
* Capable of giving informed consent (no proxies will be used to obtain consent)
* Systolic blood pressure is 130 mm Hg or greater OR Systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is diagnosed/treated hypertension prior to the stroke or TIA

Exclusion Criteria:

* Younger than 40 years
* Systolic Blood Pressure less than 120 mm Hg OR systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is no known history of hypertension prior to the stroke or TIA
* Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
* Inability to comprehend the study because of communication or cognitive impairments
Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females

With the increase in life expectancy women spend more than one-third of their life time in post-menopausal state leading to osteoporosis in later stages. Therefore a decrease in temporal-spatial parameters of gait, high risk of fracture, imbalance in functional parameters, fear of fall and compromised health-related quality of life is observed among osteoporotic females. Several physical activities and balance training programs have been implemented globally but nationally no program has yet been designed catering gait balance and fear of fall altogether as a combined program. Therefore, the aim of this study was to determine the effectiveness of Osteoanabolic exercises on Temporal-Spatial gait parameters, Gait Stability Ratio (GSR) and Bone Mineral Density (BMD) among the osteoporotic females. Moreover, the effectiveness of these exercises was evaluated on dynamic balance using Timed Up and Go Test (TUG).

Furthermore, the impact on fear of fall was identified using Fall Efficacy ScaleInternational (FES-I).

A 3-arm Randomized Controlled Trial was conducted at the Department of Rehabilitation Sciences, Ziauddin Hospital using the envelope method. The participants were screened on the Physical Activity Readiness and You Questionnaire (PARQ \&YOU). Ninety-three osteoporotic females were randomly allocated into three groups; where; participant in group A' received aerobic training protocol, a participant in group B' resistance training and participant in group C' Osteoanabolic training. A Frequency Intensity Time Type (FITT) protocol according to the American College of Sports Medicine for aerobic and resistance training was incorporated whereas for Osteoanabolic group combination training protocol was used. Twelve weeks of training was conducted where pre and post readings were calculated using activPAL, TUG, FES-I and Peripheral DXA Scan.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal osteoporotic females aged in between 50-75 years
* Not participating in any exercise program for the past 3 months
* Independently ambulatory were included in the study

Exclusion Criteria:

• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy
Whole-Body MRI in Suspected Victims of Abusive Head Trauma

The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse

Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images

Procedures to be used: whole-body MRI images

Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.


Eligibility Criteria:
Inclusion Criteria:

* younger than 12 months
* admitted to the hospital
* getting an MRI for suspected abusive head trauma

Exclusion Criteria:

-
Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy (PEACE)

To determine whether the addition of angiotensin converting enzyme (ACE) inhibitor to standard therapy in patients with known coronary artery disease and preserved left ventricular function will prevent cardiovascular mortality and reduce the risk of myocardial infarction.

BACKGROUND:

Individuals with coronary artery disease are at heightened risk for major cardiovascular events. With current advances, a larger segment of our population is manifesting coronary artery disease at a more advanced age. The majority of these individuals have preserved left ventricular function. Prior studies with converting enzyme inhibitor (CEI) therapy in patients with depressed ejection fraction have demonstrated that their long-term administration leads to improved survival and reduced risk of myocardial infarction over and above conventional therapy. There is sufficient rationale and experience to indicate that these benefits will apply to the larger group of individuals with coronary artery disease and preserved left ventricular function and therefore have even broader public health implications. A definitive trial is needed to assess the capacity of CEI therapy to prevent mortality and reduce the risk of myocardial infarction in patients with coronary disease and preserved left ventricular function.

The initiative was proposed by the former Clinical Trials Branch staff and given concept clearance at the May 1994 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in October 1994.

DESIGN NARRATIVE:

A multicenter, randomized clinical trial. There are approximately 180 centers in the United States, Canada, Puerto Rico, and Italy. Patients are randomly assigned to treatment groups in which the addition of the angiotensin-converting enzyme (ACE) inhibitor trandolapril is compared to standard therapy. The primary endpoint includes a reduction in the incidence of cardiovascular death, nonfatal myocardial infarction, or the need for coronary revascularization (PTCA or CABG) in coronary artery disease patients with left ventricular ejection fraction of 40 percent or more. Secondary endpoints include the incidence of hospitalization for the management of either unstable angina, congestive heart failure, stroke, or cardiac arrhythmia. Recruitment started in November 1996 and ended in June 2000 with a minimum follow-up of five years.

Eligibility Criteria:
Men and women patients at least 50 years of age with coronary heart disease documented by angiography and a left ventricular ejection fraction of 40 percent or more.