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NCT ID: NCT03745287 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease

Start date: November 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.

NCT ID: NCT03745222 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

RATIONALE001
Start date: May 22, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

NCT ID: NCT03745053 Completed - Clinical trials for Coronary Artery Disease

XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

XLIMIT
Start date: February 5, 2019
Phase: N/A
Study type: Interventional

The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

NCT ID: NCT03744858 Active, not recruiting - Inflammation Clinical Trials

The Role of Pyroptosis in Chronic Venous Disease

PYROCVD
Start date: November 12, 2018
Phase:
Study type: Observational

Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.

NCT ID: NCT03744468 Recruiting - Clinical trials for Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2

Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors

Start date: November 13, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of BGB-A425 and/or LBL-007 with tislelizumab.

NCT ID: NCT03744143 Completed - Endometriosis Clinical Trials

Surgical Eradication of Deep Infiltrating Endometriosis of the Vagina

ENDO-VAG-r
Start date: January 3, 2019
Phase: N/A
Study type: Interventional

Multicentric retrospective study about the comparison of two different techniques of vaginal breach suturing after eradication surgery for deep infiltrating endometriosis and the surgical approaches (laparoscopic or vaginal) in terms of surgical, clinical and functional outcomes.

NCT ID: NCT03743870 Recruiting - Clinical trials for Cesarean Section Complications

Spinal Anesthesia in Caesarean Section

Start date: June 1, 2018
Phase:
Study type: Observational

Spinal anesthesia is a safe technique, widely used and tested in the gynecological field, so as to be considered the first choice technique in cesarean section, which allows to quickly obtain a valid sensor and motor block. Bupivacaine is one of the most widely used drug for obtaining spinal anesthesia in pregnant women undergoing caesarean section. Bupivacaine is a local anesthetic available as a racemic mixture of its two enantiomers, the R (+)- dextrobupivacaine and the S (-) - levobupivacaine, whose clinical use is widely validated. Racemic bupivacaine is available as a simple or hyperbaric solution, the latter being the most commonly used for spinal anesthesia. Levobupivacaine, which is the pure levorotatory enantiomer of racemic bupivacaine, is a slightly hypobaric solution compared to liquor and has shown less heart and nerve toxicity, probably due to its ability to bind proteins more rapidly, and a greater selectivity towards the sensory component compared to Bupivacaine, presents action and effects better predictable. Its baricity would also offer the advantage of providing a less sensitive block to the position. Hypotension is one of the most common complications of spinal anesthesia and is particularly relevant in caesarean section because, in addition to the adverse effects on the parturient, it can have repercussions on the fetus through a reduction of placental perfusion. Some studies have showed a similar incidence of hypotension in patients treated with bupivacaine compared to those treated with levobupivacaine, while others assert an equivalence between the two drugs. In most studies, however, a significantly lower incidence of hypotension and a greater hemodynamic stability were reported in pregnant patients undergoing spinal anesthesia by caesarean section with levobupivacaine. Being both hyperbaric bupivacaine and levobupivacaine routinely used at the "G. Rodolico" Universitary Hospital of Catania for the spinal anesthesia of pregnant women undergoing caesarean section and being their use decided exclusively at discretion of the treating anesthesiologist, in the light of the discrepant data in the literature about the incidence of hypotension with the two drugs, the main objective of this observational study is to evaluate the hemodynamic effects mediated by levobupivacaine on pregnant women subjected to elective cesarean section and to compare them with those mediated by hyperbaric bupivacaine in an historical court of pregnant women subjected to caesarean section in the period between April 2017 and April 2018. The hemodynamic parameters will be monitored in real time with a non-invasive hemodynamic monitoring system (EV1000® platform + Clearsight® system - Edwards LifeSciences), routinely used in the "G. Rodolico" Universitary Hospital of Catania, allowing to obtain greater accuracy and veracity of the results compared to previous studies conducted on such anesthetics.

NCT ID: NCT03743480 Recruiting - Clinical trials for Hematologic Neoplasms

Early Palliative Care and Hematological Cancer Patients

EPC-EMA1
Start date: November 21, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to pilot and evaluate a new integration model between a Specialised Palliative Care (SPC) intervention and standard hematological care in an Italian hospital. This is a feasibility mix-methods study, where a sample of advanced hematological patients are randomised to receive integrated hematological care and a SPC intervention or standard hematological care throughout the course of the predictive last active treatment.

NCT ID: NCT03743467 Recruiting - Parkinson Disease Clinical Trials

Study on the Visual Condition in Parkinson's Disease

Start date: November 5, 2018
Phase:
Study type: Observational

Non motor symptoms and signs in Parkinson's disease (PD) also include a series of visual deficits; deepening these aspects could be useful for a better management of symptoms, to standardize a specific protocol for the issues related to vision and also to understand how these aspects are important for the understanding of the mechanisms underlying the PD.

NCT ID: NCT03743246 Completed - Clinical trials for Lymphoma, Non-Hodgkin

A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)

Start date: October 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, [DLBCL, BL, or PMBCL]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.