cyrilzakka/clinical-trials huggingface dataset:
Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (\~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset
* Native coronary artery disease with \>70% diameter stenosis (no prior stent implant, no prior brachytherapy)
* Vessel size in between 2.5 and 3.75 mm
* Signed patient informed consent

Exclusion Criteria:

* Lesions in coronary artery bypass grafts
* Significant left main disease
* Killip class IV
* Reecent major bleeding (6 months)
* Renal failure with creatinine value \> 2.5 mg/dl
* Allergy to aspirin and or clopidogrel/ticlopidine
* Patient in anticoagulant therapy
* IMA due to a stent thrombosis
* No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels \[≥ 3.75 mm in diameter\])
Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels

This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.

After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.

All patients and volunteers will be assigned to groups (arms) after being tried:

(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;

In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.

Eligibility Criteria:
Inclusion Criteria:

* More than 3 months after stroke;
* Ischemic or hemorrhagic stroke with upper limb motor impairment;

Exclusion Criteria:

* Any contraindication for application of transcranial magnetic stimulation;
* Peripheral lesions in the assessed upper limb;
* Score ≤ 18 at Folstein Mini Mental State Examination;
* Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
* Application of botulinum toxin in less than 6 months.
Pain During Vaccine Administration

Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.

In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.

This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 28-36 gestational week
* No congenital malformation
* follow up with a diagnosis of respiratory distress syndrome,
* receive oxygen support with a nasal cannula or tube,
* not receive mechanical ventilation support,
* no contraindications for hepatitis B vaccine administration,
* stable vital signs before vaccination,
* not receive analgesic sedation treatment
* whose parents give verbal and written consent to participate in the study.

Exclusion Criteria:

* Infants of parents who did not give informed voluntary consent will not be included in the study.
* Decreased oxygen saturation levels
* Tachycardia just before the vaccine administration
* Invasive intervention in the right hand.
Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke

This research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke.

Stroke is among the leading causes of mortality and disability, worldwide. Muscle weakness and other complications associated with stroke can result in decreased quality of life and significant declines in the activities of daily living. Mirror therapy has been shown to have a moderate effect, facilitating the functional recovery among individuals who have experienced a stroke. A prototype for a computerized, mirror therapy device was developed and found to be feasible. Recently, the investigators published a critical review and an activation likelihood estimation (ALE) meta-analysis analysing the widespread reports of brain activity associated with mirror therapy. Observations using functional near-infrared spectroscopy (fNIRS) to evaluate a group of people with stroke (n = 14) and healthy volunteers (n = 18) revealed that performing complex tasks during the mirror therapy paradigm enhanced top-down motor facilitation in the ipsilesional/ipsilateral hemisphere relative to the moving limb. An important next step in this series of studies is to evaluate the training effects associated with the performance of complex tasks during mirror therapy among stroke patients, using the designed computerized mirror therapy device to deliver the enhanced mirror therapy training. The results of this study will help the investigators to understand the underlying mechanisms through which mirror therapy facilitates motor rehabilitation and will add to the body of literature describing the best, evidence-based practices for mirror therapy during stroke rehabilitation. The investigators propose a pilot study (n = 30) to test the methodological procedures and obtain preliminary results for a fully powered, randomized, controlled trial (RCT), combined with economic evaluation, to compare the therapeutic and cost-effectiveness between standard mirror therapy and enhanced (complex task and blurred image) mirror therapy.

Eligibility Criteria:
Inclusion Criteria:

* adults with stroke (40-75 years old), with normal or corrected-to-normal vision and hearing;
* post-stroke duration of ≥ 6 months, before the start of data collection;
* no severe deficits in memory, communication, or the ability to understand verbal instructions.

Exclusion Criteria:

* participants with recurrent stroke; and
* those who score \< 24 on the Mini-Mental State Examination (MMSE).
EffectS of CAnnabidiol in Patients: Evaluation

Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis, is used in many over-the-counter products in France. Some painful patients or patients suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are no data available for patients in algology and addictology, particularly with regard to the prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the use of a substance with a therapeutic purpose but outside a medical framework and without monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main objective of the study is therefore to assess the prevalence of CBD users in algology and addictology departments. Secondary objectives are to characterize the use of CBD as well as the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive substances use or current drug treatments and the drug liking of CBD.

Physicians from algology and addictology departments will propose the study to all patients who meet the inclusion criteria during a medical consultation (in hospitalization or ambulatory care). If the patient agrees to participate, the non-opposition will be collected and the physician will complete a short form with sociodemographic data, medical history and contact details of the patient.

The form will be transmitted securely to the research staff that will perform a unique research evaluation face to face (when the patient is still hospitalized and available) or by phone (when the patient is not available during hospitalization or no longer hospitalized or in case of ambulatory care). The research evaluation includes data about the frequency and the duration of the use of all substances (CBD included) in the last 12 months and the frequency of current drug treatments. For patients with CBD use in the last 12 months, additional data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD.

A descriptive analysis will be carried out. The CBD user group and the CBD non-user group will be compared on all the variables collected. A multivariate analysis will be carried out in order to identify factors associated to CBD use in algology and addictology patients.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Patients for whom hospital specialists in algology or addictology have been requested (for hospitalized or ambulatory cares) during the inclusion period.
* Giving oral non opposition to participate.

Exclusion Criteria:

* Adults under guardianship or curator
* Patients unable to respond to the research evaluation (cerebral function disorder, difficulty to understand, read or write French language).
Cardiovascular Protective Effect of Spironolactone in Hemodialysis

The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.

Cardiovascular complications are common in dialysis patients and comprise up to 50% of deaths in end-stage renal disease population. Hypertension and left ventricle hypertrophy occur in more than 70% of patients undergoing long-term hemodialysis therapy, and both contributes to mortality and morbidity.Recent clinical trials in chronic heart failure and post miocardial infarct heart failure patients have demonstrated a beneficial effect of a mineralocorticoid receptor blocker spironolactone, in adittion to standard therapy (RALES AND EPHESUS studies). The aim of the present study is to evaluate spironolactone treatment in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

chronic hemodialysys (\> 3 months) anuria (diuresis \<200 mL/day) -

Exclusion Criteria:

Liver failure Insulin dependent diabetes Treatment with adrenergic beta blockers or agonists Treatment with converting-enzime blocker or angiotensin receptor antagonists Cancer

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Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

The purpose of this study is to examine biological pathways of altered blood vessel function resulting from breathing airborne particulate. Blood artery function in healthy men will be measured after particulate exposure either on placebo or on an asthma medication that stops production of an inflammatory biological agent. Lung and blood profiles will be obtained before and after exposure to exhaust fumes. We believe that the inflammatory agent produced by the lungs from breathing these particles causes abnormal artery function.

Hourly ice resurfacing by gas and propane fueled machines creates high levels of ultrafine and fine particulate matter (PM1) in indoor ice rinks. PM1 exposure may disrupt the normal nitric oxide (NO)/endothelin (ET)-1 vasodilation system and promote atherosclerosis, and/or increase the risk of an acute cardiac event. Our specific aims are 1) to determine whether impaired endothelial-mediated vasodilation and forearm muscle tissue reoxygenation rate and blood volume change (to reactive hyperemia following artery occlusion) is associated with combustion-derived PM1 exposure, and 2) To characterize a PM1 induced mechanism of endothelial dysfunction which occurs via a leukotriene (LT)-associated, airway generated tumor necrosis factor-alpha (TNF-a) mediated pathway. Healthy low PM1 exposed males will be evaluated for endothelial dysfunction before and after artery occlusion using high resolution ultrasound and near-infrared spectroscopy (NIRS), before and after moderate exercise in blinded high and low \[PM1\]. Endothelial dysfunction among chronically PM¬1 exposed ice rink athletes will be determined to evaluate the feasibility of using this population as a model in future studies. TNF-a, IL-8, LTB4, LTC4, LTD4, LTE4, ET-1, NO, and differential cell counts will be measured in sputum and serum. \[PM1\] will be monitored and exposure levels will be typical of indoor ice rinks. LT involvement will be assessed in vivo by double-blind pharmacological manipulation during PM1 exposure during light exercise. Results will demonstrate whether endothelial-mediated vasodilation and muscle hemodynamics are influenced by PM1 exposure, and will elucidate an LT initiated TNF-a mediated pathway in ET-1 upregulation. Our results should provide information for understanding the effects of PM1 exposure on the atherosclerotic process and cardiovascular risk, and give insight to novel treatment and diagnostic modalities.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* between 18 and 30 years of age
* participant in endurance sport

Exclusion Criteria:

* history of blood clotting
* history of coagulation problems
* History of spontaneous pneumothorax
AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
* Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
* Subjects agree to wear compression therapy daily in combination with the trial dressing.

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product.
* Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
* Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
* Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
* Subjects who have participated in a clinical study within the past 3 months.
* Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).
Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

PRIMARY OBJECTIVES:

(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18

OUTLINE:

Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

After completion of study, participants are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
* Educational component: men over the age of 18
* Screening component: men over age 40

Exclusion Criteria:

* Known personal history of prostate cancer
* Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.

This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)

Part 1:

Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio

Part 2:

Approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). A total of 24-36 subjects may be randomized in the 3 dose groups.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥18 years of age.
* Subjects on hemodialysis for at least 12 weeks before screening
* Subjects on a stable dose of Erythrocyte Stimulating Agents product to maintain Hemoglobin (Hb) for at least 6 weeks prior to screening.
* 3 consecutive pre-dialysis Hb concentrations with a mean ≥10 to ≤ 12 g/dL (≥100 to ≤120 g/L) at screening and one pre-dialysis Hb concentration ≥8 to \< 10 g/dL (≥ 80 to \< 100 g/L) before randomization.
* Adequate iron status defined as serum transferrin saturation ≥ 20% before randomization.

Exclusion Criteria:

* Non renal causes of anemia.
* Subjects on peritoneal dialysis.
* Systemic hematological disease
* High sensitivity C-reactive protein \>50mg/L at screening.
* Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values \> 2 times the upper limit of normal (ULN) at screening.
* Uncontrolled diabetes mellitus (HbA1c \> 9) at screening.
* Uncontrolled hypertension.
* Red Blood Count (RBC) transfusions within 8 weeks prior to screening.
* Active serious infection or history of recurrent serious infection likely to recur during the study
* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product or to the iron products needed to normalize iron levels for subjects.
* Subjects that received treatment with another investigational drug or device within 28 days prior to Day 1
* Pregnant or lactating females.