cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.

The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.


Eligibility Criteria:
Inclusion Criteria:

* CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.

Exclusion Criteria:

* Infection
* High grade spinal stenosis
* Contraindications to MRI
* Dementia
A Study to Evaluate the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus ICE Regimen in Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed First-line Standard Chemotherapy

This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.

randomized, double-blind, two arms , multicenter

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Histopathologically confirmed cHL
3. Failed first-line standard combination chemotherapy
4. One measurable lesion (Lugano 2014)
5. Eastern Cooperative Oncology Group (ECOG) of 0-1
6. Male or female aged ≥18 years
7. Patients must have adequate organ and bone marrow function

Exclusion Criteria:

1. Patients must not have known central nervous system (CNS) involvement
2. Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
3. Patients may not simultaneously participate in another interventional clinical study
4. Patients may not receive any other investigational agents within 4 weeks of study registration
5. Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
6. Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period)
7. Patients with known immunodeficiency are ineligible
8. Patients with known active TB (Bacillus tuberculosis) are ineligible
9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
10. Patients must not be pregnant or breastfeeding
Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration

The etiology of non-healing ulcers depends on both systemic and local factors. The introduction of advanced dressing, negative wound therapy and compression therapy have undoubtedly improved clinical outcomes. The principal aim of study was to demonstrate the efficacy of skin micrografts in the treatment of skin substance loss.

The principal aim of study was to evaluate the efficacy of skin micro-grafts obtained with the system of mechanical disintegration in the reconstruction of skin substance loss in the limbs.

The primary endpoint consists in evaluating, through a specific evaluation scale, the Wound Bed Score (WBS) for skin substance loss at Time 0 (T0) and 30 days after the procedure (T30) and to evaluate the increase of this score in this time frame set at 50%. The evaluation will be carried out in double blind.

The secondary endpoints instead consist in the evaluation of the Wound Surface Area Assessment to be carried out at T0 and T30.

In the evaluation of the quality of the resulting scars, through the Vancouver Scale (VS), 90 (T90) and 180 days (T180) after treatment and to evaluate the reduction of this score by 15%; on the other in the evaluation of the progress of the Visual Analogic Scale (VAS) administered to the patient at T0, 30, 90, 180.

The purpose of this minimally invasive treatment is to improve the quality of life of those affected by these injuries, avoiding the use of prolonged advanced medications and / or more invasive surgical procedures, thus speeding up healing and favoring the clinical outcome of patients.

No chemical reagents or enzymes are used for the method. There is therefore no tissue manipulation, in full compliance with the European directive 23/2004.

Eligibility Criteria:
Inclusion Criteria:

* Full-thickness skin loss from a minimum size of 3x3 cm (9cm2) to a maximum size of 5x5 cm (25cm2);
* Loss of substance caused by abrasive-contusive traumas (loss of full-thickness skin substance) or by thermal burn (deep degree II), present for at least 15 days;
* Absence of clinical signs of infection assessed by two culture swabs performed at T0 (pre and post debridement);
* Pre-operative inflammatory index (VES, PCR) and b-hcg negative;
* Absence of exposure of osteo-cartilaginous structures, of noble structures (major arterial vessels, major nerve trunks, tendons without paratenon);
* Specific written informed consent

Exclusion Criteria:

* Smoking patients (≥ 10 cigarettes / day);
* Patients with type I or type II diabetes mellitus:
* Patients suffering vascular trophic ulcers;
* Patients with loss of substance at the level of the fingers and toes;
* Patients with loss of substance of the foot and the yarrow region;
* Patients with oncological pathologies in progress or in remission;
* Patients in therapy with immunosuppressive and corticosteroid drugs, anticoagulants, antiplatelet agents;
* Patients with autoimmune diseases including connectivitis;
* Patients with congenital, acquired and metabolic immunodeficiencies;
* Pregnant patients (ascertained with β-HCG) and breastfeeding.
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma

The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Mantle cell lymphoma
* Previous treatment for mantle cell lymphoma
* Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens.
* Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day)
* Adequate organ function

Exclusion Criteria:

* Inability to swallow tablets
* Must not have significant heart problems
Description of Respiratory Mechanics in Patients With SARS-CoV-2 Associated ARDS

The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

The investigators perform an observational prospective study in patients admitted to medical ICU in Angers University hospital with a confirmed COVID 19 pneumonia and who require invasive ventilation on endotracheal tube. Participants receive initially deep sedation and neuromuscular blockers for 24 hours and are ventilated in volume-controlled mode with a tidal volume of 6 mL/kg of predicted body weight, a constant inspiratory flow of 60 L/minute and a respiratory rate adjusted to maintain pH above 7.35 when possible. A PEEP decremental trial from 15 to 5 cmH2O was performed (15 minutes by step).

Esophageal pressure monitoring and electrical impedance tomography (EIT) are collected if available. Arterial blood gases and respiratory mechanics are measured at the end of each step.

The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 is used to define highly recruiter patients.

By the end of the recording time, a low-flow (5 L/min) inflation from PEEP 5 cmH2O (tidal volume = 6ml/kg PBW) is then performed after a prolonged expiration to identify a potential airway closure and the corresponding airway opening pressure (AOP).

Investigators perform these measurements at day 1, day 5 and day 10 from ICU admission if participants still require controlled ventilation.

The investigators also collect clinical data about each participant (past medical history, ICU discharge, hospital discharge, date of death, ventilator acquired pneumonia, thromboembolic event, use of NO, use of ECMO or renal replacement therapy).

Eligibility Criteria:
Inclusion Criteria:

* ARDS criteria according to Berlin classification criteria
* Invasive mechanical ventilation on endotracheal tube
* SARS Cov-2 infection

Exclusion Criteria:

* pneumothorax
Application of 3D MR Neurogram for Intraparotid Facial Nerves Evaluation

Parotid neoplasm consists of a wide range of benign and malignant lesions, and parotidectomy has been the mainstay for management of these neoplasms. Within the parotid gland there are branches of the intra-parotid facial nerves, which are tiny in calibre and are prone to injury to injury during operation. It has been reported in recent retrospective view that the incidence of temporary and permanent facial nerve injury were 9.2% and 5.2% respectively, the risk of which increased with old age, malignant tumour and revision surgery. Traditional the incidental of facial nerve injury is reduced by intra-operative facial nerve monitoring and surgical magnification, while imaging has limited role in aiding this purpose. However with advancement in MRI technique high resolution three-dimensional sequences (i.e. neurogram sequences) are available for better visualization of branches of facial nerves. The investigators would therefore aim to demonstrate additional efficacy of these techniques and also to compare with conventional 3D post-contrast anatomical imaging studies in the localization and visualization of the facial nerve branches in patients with tumour. With better pre-operative imaging, the investigators hope to reduce the chance of facial nerve injury in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with parotid tumour diagnosed on other imaging modalities (such as ultrasonography or computed tomography), with or without cytological diagnosis from fine needle aspiration, will be recruited from the ear, nose and throat specialty clinic.

Exclusion Criteria:

* Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)
* Patient who are contraindicated to MRI contrast agents (such as advanced renal failure or previous severe allergic reaction)
* Patients who cannot cooperate for MRI scanning.
* Patients show are unable to provide informed consent.
Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

Previous studies have shown that expectant management of preeclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. In this study, we evaluate the use of Esomeprazole alone or with Sildenafil Citrate for the treatment of singleton pregnancies complicated by preeclampsia. We hypothesized that the potential increase in uteroplacental and fetoplacental blood flow with the use of Esomeprazole alone or with Sildenafil Citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes.

The etiology and pathophysiology of preeclampsia have not been clearly established; impaired immunologic adaptation and genetic incompatibility seem to be involved in deficient trophoblastic implantation. Placental hypoxia and endothelial dysfunction may lead to preeclampsia through an exacerbated systemic inflammatory reaction. Increased placental expression and secretion of soluble fms-like tyrosine kinase 1 appear to play a central role in the pathogenesis of preeclampsia. The soluble fms-like tyrosine kinase 1 antagonizes the proangiogenic biologic activity of circulating vascular endothelial growth factor and placental growth factor, leading to a failure of nitric oxide signaling to smooth muscle The investigators will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
* The patient will be managed with an expectant management
* Give written informed consent

Exclusion Criteria:

* Multiple pregnancies.
* Previous hypersensitivity reaction esomeprazole or sildenafil citrate
* Contraindications to the use of esomeprazole or sildenafil citrate
* The patient is unable or unwilling to give consent
* An established fetal compromise that necessitates delivery
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria

* Eligible for percutaneous coronary intervention (PCI)
* Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
* Documented LVEF ≥25% within the last 6 weeks.
* Eligible for coronary artery bypass graft surgery (CABG)

Exclusion Criteria:

General Exclusion Criteria: -

* Known sensitivity to paclitaxel or polymeric matrices.
* Planned treatment with any other PCI device in the target vessel(s).
* MI within 72 hours prior to the index procedure
* Patient is in cardiogenic shock
* Cerebrovascular Accident (CVA) within the past 6 months
* Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
* Contraindication to ASA or to ticlopidine
* Thrombocytopenia
* Active GI bleeding within past three months
* Known allergy to cobalt chromium
* Any prior true anaphylactic reaction to contrast agents
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease

Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).

This study is a prospective, randomized, controlled study, follow the principle of PICOST design, specific as follows: Participants (the list) : preliminary clinical diagnosis of coronary atherosclerotic heart disease, heart failure. Intervention (Intervention) : conventional drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months Intervention. Comparator(control): conventional drug therapy + traditional cardiac rehabilitation therapy. The traditional cardiac rehabilitation therapy referred to domestic and international guidelines and consensus, and used 1 week-3 months of treatment intervention according to the actual situation of patients. Outcome (the end) : the primary end point: D_SPECT examination, were followed up for 6 months to evaluate myocardial perfusion imaging is reduce ischemic area. The secondary end point: 1) the blood biochemical examination and myocardial necrosis markers, etc.; 2) the cardiopulmonary exercise testing: maximum kilograms oxygen uptake and anaerobic threshold when the maximum kilograms oxygen uptake; 3) the major adverse cardiovascular events: cardioascular death, non-fatal myocardial infarction, unplanned coronary artery reconstruction, stroke, heart failure and angina associated hospitalized again; 4) patients family rehabilitation treatment adherence

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 85 years old
* Female subjects no pregnancy
* The main admission diagnosis of ischemic heart disease (coronary heart disease, myocardial infarction, ischemic heart failure, etc.)
* The need for cardiac rehabilitation treatment

Exclusion Criteria:

* acute respiratory distress syndrome (ARDS);
* acute episode of COPD;
* uncontrolled pulmonary infection;
* acute heart failure; acute pulmonary embolism;
* acute myocarditis/pericarditis;
* severe arrhythmia (degree II or III atrioventricular block, atrial flutter, or atrial fibrillation);
* sternotomy, rib fracture, thoracic deformity, or other neurological diseases that may affect respiratory muscles
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years.
* paroxysmal atrial fibrillation
* failure of at least one AAD
* others

Exclusion Criteria:

* overall good health as established by multiple criteria
Functional Resistance Training to Improve Knee Function After ACL Reconstruction

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.

Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.

Eligibility Criteria:
Inclusion Criteria:

* aged 14-40 years
* suffered an acute, complete ACL rupture
* willingness to participate in testing and follow-up as outlined in the protocol
* English-speaking

Exclusion Criteria:

* inability to provide written informed consent
* female subjects who are pregnant or are planning to become pregnant
* previous ACL injury
* previous surgery to either knee
* bony fracture accompanying ACL injury
* patients who experienced a knee dislocation;
* patients who are contraindicated for transcranial magnetic stimulation (e.g., metal implants in head, unexplained recurrent headaches, history of seizures, epileptogenic drugs, active psychiatric illness, etc.).
Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.

Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.

This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* caucasian women \<70 years, in physiological postmenopausal status for at least 2 years;
* women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness);
* signed informed consent; willing and able to comply with study procedures

Exclusion Criteria:

* childbearing potential women;
* ascertained or presumptive hypersensitivity to the formulation ingredients;
* therapy with systemic or vaginal oestrogens within 6 months from the inclusion;
* current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion);
* previous episodes of vaginal bleeding or spotting in the last 6 months;
* vaginal prolapse and any other disease that could interfere with the study conduction and participation
Effects of Providing Preprint Preoperative Anesthetic Risk Information

Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group


Eligibility Criteria:
Inclusion Criteria:

* Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
* Low to moderate risk surgery

Exclusion Criteria:

* Patient's refusal
* Patients scheduled for cardiovascular surgery and neurosurgery
* Patients with consciousness change following surgery
* Emergency case
* CNS or psychological diseases