cyrilzakka/clinical-trials huggingface dataset:
Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.

To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD).

Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing a clinically significant stenotic lesion during follow-up. They are at risk of myocardial infarction-related sudden death or congestive heart failure as young adults. Bypass surgery could be the reasonable strategy but the long-term patency of the graft remains unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the alternative. However, metallic stenting remains problematic in several aspects mainly due to the restriction of vessel expansive remodeling. The novel BVS has the potential to be free from the limitation due to scaffold degradation.

we will conduct a single-center, single-group prospective study with safety and imaging endpoints. A total of 10 KD children or young adults with indication of revascularization are enrolled, and BVS will be implanted for stenotic or occluded lesions. QCA and optical coherence tomography (OCT) are used to evaluate the baseline lumen area, plaque characteristics, and BVS expansion or eccentricity after deployment. At 12 months, scaffold restenosis is evaluated by multislice computed tomography. At 30 months, patients will receive follow-up by angiography and OCT to evaluate lumen area, neoplaque characteristics, and side branch conditions. Otherwise, the composite endpoint including cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation are assessed at 30 days, 6 and 9 months, and 1, 2, 3 years.

Eligibility Criteria:
Inclusion criteria:

1. In the single-group prospective study with safety and imaging endpoints, a total of 10 KD patients \< 18 years will be enrolled.
2. The diagnosis of KD was made based on clinical criteria for KD.

Exclusion criteria:

Patients presenting with an acute myocardial infarction or unstable arrhythmias, or those who has severe left ventricular dysfunction (ejection fraction less than 35%), intrastent restenotic lesions, lesions located in the left main coronary artery, and tight lesions which could not be well dilated even after rotational atherectomy are excluded. Those with chronic renal insufficiency (creatinine \>1.5 mg/dl) are also excluded due to the limitation of OCT (optical coherence tomography) use.
Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed


Eligibility Criteria:
Inclusion Criteria:

* wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
* Single level fracture
* Less than 50% of spinal canal compromised
* Mild kyphosis or scoliosis
* Cobb's angle ≤ 25˚
* with or without neurological deficit

Exclusion Criteria:

* patients with multiple level fractures
* patients with more than 50% spinal canal compromise
* patients who needed anterior approach to decompress the canal
* patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle \>25⁰
* patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
Everolimus in de Novo Heart Transplant Recipients

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.


Eligibility Criteria:
Inclusion criteria:

* Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation.
* Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

Exclusion criteria:

* Patients who are recipients of multiple solid organ transplants
* Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive;
* Presence of Donor/Recipients serological mismatch for Hepatitis B or C;
* Recipients of organ from donors positive for Hepatitis B-surface antigen;
* Panel Reactive Antibodies (cytotoxicity method) \> 30%.
* Other protocol-defined inclusion/exclusion criteria may apply
Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

Correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent Kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.


Eligibility Criteria:
Inclusion Criteria:

* Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection
* Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing
* May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation
* Have history or no history of lymphedema or have or not been treated for lymphedema;
* Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention.
* Women willing to come to the NYU Perlmutter Cancer Center for the research visit.

Exclusion Criteria:

* Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema;
* Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions;
* Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
* Must have had endoscopic/radiologic bowel evaluation within the past 10 years
* Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
* Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding

Exclusion Criteria:

* Serious underlying diseases, including psychiatric disorders
* Current history of conditions affecting bowel transit
* Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
* Clinically significant abnormal examination findings or laboratory tests
* Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
* Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
* Presence of a medical condition which could interfere with the interpretation of study data
* Significant use of nicotine or caffeine
Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Pulmonary Vein Stenosis

Prospective, single center, descriptive study in 14 infants/children with multivessel pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.

Group 1: Patients without additional structural heart disease and multivessel pulmonary vein stenosis.

Group 2: Patients with additional structural heart disease and multivessel pulmonary vein stenosis.

Patients identified at the time of presentation to their cardiologist will be asked to provide a urine sample for analysis. If blood is being drawn for other clinical tests, an extra vial of blood will be collected for measurement of bFGF, VEGF, angiopoietin 1\&2 and ephrin. At the time of blood draws, approximately 4 cc's of heparin blood will be obtained and processed as detailed below. Blood and/or urine samples will be coordinated through the data manager and will be performed only when blood is being obtained for other reasons. Initially, blood samples will be sent to Lab Control, spun down, and the plasma isolated. Plasma will be coded, then frozen at -200C in the research lab. Urine samples will be aliquoted into vials and stored at -20 until further analysis.

All patient information will be kept confidential. Individual results will not be provided to patients. Identifiers to patient information will be maintained. No identifying patient information will be used in publications that might result from these studies. Information to be collected by the data manager will include age, sex, date of diagnosis and interventions.

The specific aim is to assess angiogenic growth factor concentrations in urine and blood from patients with both congenital and acquired multivessel pulmonary vein stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis.
* There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins.
* Must give written informed consent according to institutional guidelines

Exclusion Criteria:

* Mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study

To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.


Eligibility Criteria:
Inclusion Criteria:

* Senile cataract
* Patient identified as a candidate for cataract surgery and IOL implantation
* Willing to sign informed consent document approved by the Ethical Committee
* Willing to complete all required tests and exams per this protocol

Exclusion Criteria:

* Amblyopia
* History or evidence of any ocular disease that may affect visual acuity
* Previous ocular surgery, including refraction surgery
* Ocular anomalies (e.g. microphthalmos, kerataconous)
* Subjects with greater than 1.0 D of corneal astigmatism
* Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone

A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone

Exclusion Criteria:

* Less than 30 degrees of volar angulation in the fracture
* rotational deformity
* pseudoclawing
* intra-articular involvement
* ad latus displacement more than one half of a bone width
* concomitant fractures or soft tissue damage
* admittance more than 14 days after injury
* non-compliant patient (language, drugs, tourist)
* patient who refuses to participate in the study
Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial

Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.

The calcaneocuboid joint is stable, even although multiple conditions might affect the joint, ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures such as triple arthrodesis and is less used as isolated fusion.\[1\],\[2\],\[3\] What the most effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may affect foot that cause pain ; and there are many methods for relieve that pain , one of these is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular , calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging. Fixation with a locking compression plate (LCP) may be easier to perform while achieving compression perpendicular to the fusion site. Investigators suppose that plate is more powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare the load to failure and the stiffness for each fixation method. \[4\],\[5\],\[6\] literature reveal that: More stability to the fusion site can be applied by using plate fixation. Rationale of the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare to plate fixation? \[7\]

Eligibility Criteria:
Inclusion Criteria:

all patients who will be operated by calcaneocuboid fusion for any indication age range 18-65 no paralytic patients

Exclusion Criteria:

* age \< 18 , \> 65 acute calcaneal fracture infection non union bone defect that need bone graft refusing to participate in the study neuropathic patients
Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)

The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program.

The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.

The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.

Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.

The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).


Eligibility Criteria:
Inclusion Criteria:

People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection

Exclusion Criteria:

none
Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy.

The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

Multicentric cross-sectional survey of patients seen in the context of a rheumatology consultation or hospitalization.

On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up to assess their compliance with biologic drugs, their vaccination coverage, their diet, the presence of a fibromyalgia syndrome or inflammatory bowel disease, intestinal disorders, regular physical activity and sedentary lifestyle, the frequency and mode of use of mobile applications and/or connected objects related to health, the presence of catastrophic thoughts and the presence of anxiety and depressive disorders. Medical data relevant to routine care will be collected.(Age, sex, weight, height, tobacco and alcohol use, disease characteristics, SpA treatment, comorbidities)

Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years old with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.
* French-speaking, without any understanding problems.

Exclusion Criteria:

* Patients under curatorship, guardianship or other legal protection
* Patients refusing to consent to participate in research
* Pregnant and breastfeeding women.
Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin on recurrent events in patients with established DM who is admitted for an ACS.


Eligibility Criteria:
Inclusion Criteria:

* • Men or women ≥40 years of age admitted with a clinical diagnosis of ACS. The diagnosis should be based on the combination of typical ischemic chest complaints and objective evidence of myocardial ischemia or myocardial necrosis as demonstrated by the electrocardiogram (ECG) or elevated cardiac markers, as follows:
* Typical ischemic chest pain, lasting 10 minutes or more, within the preceding 24 hours, AND either
* ECG changes indicative of myocardial ischemia within 24 hours after the onset of chest pain (ECG showing persistent or non-persistent ST-segment elevation \>1.0 mm in two or more contiguous leads or dynamic ST-segment depression \>1.0 mm in two or more contiguous leads) or
* Elevated biomarkers of myocardial necrosis within 24 hours after the onset of chest pain (i.e. CK-MB \>1 times the upper limit of normal of the local laboratory, or Troponin-T \>0.1 ng/ml.

  * A diagnosis of DM type II prior to the index ACS
  * Written informed consent

Exclusion Criteria:

* • Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).

  * Severely-impaired left ventricular function (ejection fraction \<30%) or end-stage congestive heart failure NYHA-class III or IV (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).
  * Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of \<30 ml/min/1.73m2, or renal dialysis.
  * Co-existent condition associated with a life-expectancy \<12 months, or otherwise unlikely to appear at all scheduled follow-up visits.
  * Known serious or hypersensitivity reactions to HMG-CoA reductase inhibitors.
  * Triglyceride (TG) level ≥500 mg/dL (5.65 mmol/L) at screening, because patients with very high triglyceride levels warrant treatment with agents that may increase the risk of side effects associated with statin drugs.
  * Active liver disease or hepatic dysfunction, as determined by alanine aminotransferase (ALT \[SGPT\]) \>3 x ULN or bilirubin levels \>1.5 x ULN at screening.
  * Myopathy.
  * Not using effective contraceptive methods.
  * Participation in any investigational drug study less than 30 days prior to enrolment.
Effectiveness of Hydroxychloroquine in Covid-19 Patients

To find the effectiveness of hydroxychloroquine alone and adjuvant with azithromycin in mild to severe Covide-19 pneumonia patients admitted to Coronavirus cell/ward of Ayub Teaching hospital, Abbottabad Pakistan. A single centered, single-blind randomized control trial study.

Coronavirus (SARS-nCoV-2) is a member family coronaviridae, order Nidovirales. It is single-stranded, positive sense enveloped RNA discovered in early 1960s. Coronavirus pandemic put a lot of lives at stake. By 19 March 2020, a total of 219238 confirmed cases with 8967 being dead and 85742 recovered cases have been reported. Worldwide, in 9 days, the confirmed death cases have been doubled. The average death rate of Covid-19 per day is approximately 88 patients as of the given date. Unlike, SARS-CoV and MERS-CoV, the disease progression and mortality rate of Covid-19 is startling. The pre-pathogenic course of novel Covid-19 is yet to be determined, so the risk factors, clinical picture and medical intervention too. Only supportive therapy is being practised. Yet many trials of antimalarial drug, chloroquine and quinolone is currently taking place worldwide. According to Cortegiani A, 23 ongoing trials from China have been registered. Clinical experience from recent Wuhan epidemic came up with promising results of chloroquine and hydroxychloroquine in Covid-19 positive patients. Some in-vitro studies suggest that these immunomodulant drugs can interfere with SARS-nCov-2 replication. These are federal drug authority approved medicine for malaria. Yet their effectiveness and safety in treating Covid-19 pneumonia is a question mark.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
* Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria:

* Covid-19 critically ill patients (NEWS-2 score \<7),
* Unable to take oral medication,
* Immunocompromised,
* Creatinine clearance (CCL) \< 30 ml/min,
* Aspartate transaminase (AST) or alanine transaminase (ALT) \> 5 times Upper limit of normal (ULN),
* d-dimer \> 2microgram per liter, or
* Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
* BMI less than 18
* Smoking history (one pack per day) for past six months