cyrilzakka/clinical-trials huggingface dataset:
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB

International multicenter, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the rate of ischemic and bleeding adverse events of a single antiplatelet regimen (SAPT) since the time of PCI with latest generation DCB in elderly or HBR population with stable or unstable coronary syndromes.

The purpose of PICCOLETO IV study is to observe and evaluate the efficacy and safety of a single antiplatelet therapy (SAPT) after successful DCB angioplasty with Essential Pro (Drug-coated balloon (iVascular) in native coronary artery disease in vessels with diameter \>=2.0 and \<=4.0 mm as compared to the routine dual antiplatelet therapy (DAPT). Patients with stable or unstable coronary syndromes will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* successful PCI with solo-DCB just performed, in 1, 2 or 3 coronary vessels;
* stable or unstable coronary syndromes;
* de novo coronary lesions in vessels with diameter \>=2.0 and \<=4.0 mm (visual estimation);
* informed consent to participate in the study;
* at least one of the following criteria: \>=75 y.o.; high bleeding risk (ARC criteria)

Exclusion Criteria:

* stent implantation during index or recent (\<6 months) procedure;
* patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, contrast media, which cannot be adequately pre-medicated;
* patients participating in another clinical study; - pregnancy at the time of hospitalization;
* ST-elevation myocardial infarction;
* life expectancy \<12 months;
* left ventricular ejection fraction \<30%;
* visible thrombus at lesion site;
* target lesion/vessel with any of the following characteristics:

  * severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);
  * left main stem stenosis \>50%;
  * target lesion is in the left main stem;
  * chronic total occlusion with anticipated necessity of retrograde approach;
  * lesion is in a bypass graft.
Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy.

The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis and neuromodulation. This technique enables treatment of the tendinopathies. To analyze the effectiveness of therapeutic percutaneou electrolysis and neuromodulation in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: percutaneou electrolysis and neuromodulation associated with eccentric exercises or conventional treatment of Physiotherapy with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols.
* Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus.

Exclusion Criteria:

* Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder.
* Individuals have received the proposed treatment in one month´s period previously.
* Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
* Pregnant women can not receive this treatment intervention.
NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels

In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use, control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake restriction, smoking cessation.

Correcting anaemia in these patients may prevent impairment of renal function. International guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct an interventional randomized trial to evaluate the potential benefit of an haemoglobin level of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a Cockcroft's creatinine clearance of 25 - 60 ml/min.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes. Age between 18 and 80 years, male or female. Cockcroft's clearance between 25 and 60 ml / min. Haemoglobin level superior to 100 g/L and strictly inferior to 130 g/L

Exclusion Criteria:

Malignancy Solid organ transplant Acute pathology in the two months before inclusion date Myocardial infarction, stroke, pulmonary embolism in the six months before inclusion date Contra-indication to martial treatment or EPO treatment Present inclusion in another clinical study Patient who cannot answer questions of SF36 questionnaire
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)

Every year, thousands of patients worldwide with drug resistant focal epilepsy (DRE) undergo resective brain surgery with the aim of achieving seizure freedom.

Despite technical advances over the last 50 years, the success rate of epilepsy surgery in terms of seizure freedom has not greatly improved, remaining overall at around 50%. Depending on features of individual cases, presurgical evaluation includes a first phase of non-invasive data including video-EEG recordings, magnetoencephalography, structural and functional neuroimaging and neuropsychological evaluation. If these investigations do not allow adequate localization of likely region of seizure organization in the brain (the epileptogenic zone, EZ), then a second invasive phase using intracerebral EEG recording may be necessary (stereoelectroencephalography, SEEG). Interpretation of SEEG remains difficult in many cases, in particular since seizure onset is often characterized by discharges that very rapidly involve several distinct brain regions.

No reliable measuring instrument currently exists to combine the various prognostic factors for a given patient. This leads to great uncertainty on an individual scale in predicting the effects of surgery. The mapping of epileptic networks in patients with DRE is an innovative scientifically-validated and clinically-tested method to significantly improve accuracy of SEEG and presurgical interpretation and guide surgical strategies in patients with DRE. Therefore, the investigators developed the Virtual Epilepsy Patient software. Retrospective study already demonstrated the pertinence of this approach in improving the anatomical mapping of epileptogenic networks. Now, the investigators aim to prospectively demonstrate the role of VEP during presurgical evaluation of DRE patients


Eligibility Criteria:
Inclusion Criteria:

* Patient or pediatric patient suffering from drug-resistant focal epilepsy.
* Standardized presurgical evaluation including medical history, scalp video-EEG, 3T MRI (DTI and rsMRI), FDG-PET, Neuropsychological tests.
* Inpatient in one of the participating centers for recording seizure during long term SEEG-monitoring.

Exclusion Criteria:

* Epilepsy surgery performed without the requirement of SEEG or contra-indication to epilepsy surgery.
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients

In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.

Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.

Insertion success rate and oropharyngeal leak pressure were also measured.


Eligibility Criteria:
Inclusion Criteria:

* ASA I/II
* female
* age 19-65 years

Exclusion Criteria:

* \< 19 years
* had a known or predicted difficult airway
* a body mass index \> 35 kg m-2, or
* were at risk of aspiration
Deep Core Muscles and Biopsychosocial in Asymptomatic Adults and NSCLBP

The goal of this observational study is to (1) investigate age effects on core muscles, sensorimotor system, psychosocial factors in asymptomatic adults across years of age; (2) explore the differences in biopsychosocial factors between asymptomatic adults and people with non-specific chronic low back pain (NSCLBP); (3) study the correlations between biopsychosocial factors in people with NSCLBP.

The main questions it aims to answer :

1. Are the core muscles, lumbar propriocpetion, and psychological measures altered as age increases?
2. Do the core muscles, lumbar propriocpetion, functional performance, psychological measures, disability, and quality of life affected by NSCLBP?
3. following (2), if so, are there correlations between the measured biopsychosocial factors, disability, and quality of life in people with NSCLBP?

Researchers will compare between people with NSCLBP and age-matched asymptomatic participants across years of age to see if the effect of age and effect of NSCLBP existed in biopsychosocial factors.

Participants will

1. be observed by ultrasound image at the low back and abdominal areas to collect parameters related to trunk deep core muscles, such as changes in muscle thickness from resting state to contraction;
2. ungergo MRI examination to acquire image of deep core muscles;
3. perform lumbar repositioning test which quantifies the lumbar proprioception;
4. perform Timed Up-and-Go Test and Five-Times Sit-to-Stand test, which are used as a measurement of physically functional performance;
5. fill out the psychosocial questionnaires including: Patient-Reported Outcomes Measurement Information System Short Form Depression 4a and Anxiety 4a, Pittsburgh Sleep Quality Index, Pain Catastrophizing Scale, Fear-Avoidance Belief Questionnaire, Oswestry Disability Index, and Heath Survey Short Form-36.


Eligibility Criteria:
Inclusion Criteria:

* aged above 20 years old
* Non-specific chronic low back defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain.

Exclusion Criteria:

* history of surgery at the low back or lower extremity
* neurological symptoms, such as numbness or tingling
* not able to walk or stand independently
* cancer
* systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus
* in pregnancy
Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI

This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.

PRIMARY OBJECTIVES:

I. To determine how surgical treatment is influenced by the three imaging arms.

II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).

SECONDARY OBJECTIVES:

I. In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).

II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms.

OUTLINE: Patients are assigned to 1 of 3 treatment groups.

GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.

GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.

GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.

All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.

Eligibility Criteria:
Inclusion Criteria:

* Competent to provide informed consent
* Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy
* Eligible for breast conserving surgery followed by radiation therapy

Exclusion Criteria:

* Women with surgical excisional biopsy that diagnosed the breast cancer
* Women with clinical or mammographic findings where breast conserving surgery is not an option
* Women that clinically or mammographically have breast cancers that are fixed to skin
* Women receiving neoadjuvant chemotherapy prior to surgery
* Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)
Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients

The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.

The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.

We hypothesize that salt intake will affect OA blood flow.

We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Heart Attack or Stroke within the last 6 months
* Pregnant or lactating females
Evaluation of Circulating Osteogenic Factors in Trauma Patients

Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster than in other patients. However, such patients are also occasionally prone to bone formation in soft tissues such as muscle. This process is called heterotopic ossification and tends to occur around joints. Patients with heterotopic ossification often suffer from complications such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of movement can also interfere with function and the quality of life of patients already experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene become difficult and even impossible, which worsens the loss of autonomy.

Previous research has suggested that an osteoinductive factor (which has the capacity to induce the formation of bone) may be released into the bloodstream following a head or spinal cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged muscle. The investigators would like to find out whether the levels of BMP-9 and/or its receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that occur at the same time as serious orthopaedic traumas.

The main goal of the investigators study is thus to determine whether BMP-9 levels increase in the serum of trauma patients.


Eligibility Criteria:
Inclusion Criteria:

* cranial trauma with Glasgow =\< 8
* spinal trauma with ASIA A, B, C
* high-velocity fracture of femur, tibia, pelvis

Exclusion Criteria:

* brain dead
* pathological fractures (cancer, osteoporosis)
* blood transfusion received
* pregnancy
"Evaluation of Postural Control in Children With Increased Femoral Anteversion"

The relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. To our knowledge there is no study to evaluate postural control in children with increased femoral anteversion by computerized posturography. We aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).

Femoral anteversion is defined as the angle formed by the femoral condyles plane (bicondylar plane) and a plane passing through the center of the neck and femoral head. Toe-in-gait pattern may be due to foot deformity (metatarsus adductus) and / or abnormal transverse alignment of long bones (tibial torsion and / or increased femoral anteversion). Transverse plane deviations are frequently seen in infants and usually improve with typical physiological growth mechanisms. Persistent transverse plan disorder may lead to gait dysfunction. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. To our knowledge the relationship between increased femoral anteversion and postural control in healthy children has not been studied in the current literature. Postural control in children with increased femoral anteversion was evaluated by computerized posturography. In this study, we aimed to evaluate postural control in children with increased femoral anteversion using computerized dynamic posturography (Biodex Balance System).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as bilateral increased femoral anteversion
* No history of neurological, psychiatric diseases
* Lack of intellectual disability to prevent evaluation and treatment participation
* No participation in any physiotherapy program in the last six months
* Written permission from the parents for participate in the study

Exclusion Criteria:

* History of surgery or BoNT-A for lower extremities
* Leg length discrepancy
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older
* Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) \> or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers with a smoking history of more than 10 pack-years
* Body mass index (BMI) between 18 and 33 kg/m2
* Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria:

* Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis
* Total blood eosinophil count \>/=600/mm3.
* Thoracotomy with pulmonary resection
* Regular use of daytime oxygen therapy
* Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program
* Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
* Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
* Acute pulmonary exacerbation
* Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
* Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones
* Oral beta-adrenergics, beta blockers
* Long acting anti-cholinergics within 2 weeks prior to pre-study examination
* Inhaled or oral steroids
* Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
* Antihistamines, antileukotrienes prescribed for asthma
* oral cromolyn sodium or oral nedocromil sodium
Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis

Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.

Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.

Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.

Eligibility Criteria:
Inclusion Criteria:

* Deep endometriosis
* Surgical treatment
* Single surgeon

Exclusion Criteria:

* Lost to follow-up
* unwillingness to answer the interview