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NCT ID: NCT03616470 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

Start date: October 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

NCT ID: NCT03614260 Active, not recruiting - Hypertension Clinical Trials

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

RADIANCE-II
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

NCT ID: NCT03613246 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population

FOLLOW
Start date: February 20, 2019
Phase:
Study type: Observational

The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.

NCT ID: NCT03612869 Active, not recruiting - Clinical trials for Mucopolysaccharidosis Type IIIA

Study of AAVrh10-h.SGSH Gene Therapy in Patients With Mucopolysaccharidosis Type IIIA (MPS IIIA)

AAVance
Start date: December 17, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients.

NCT ID: NCT03611517 Recruiting - Cervical Cancer Clinical Trials

Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer

SPARC
Start date: August 7, 2018
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and written information). Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n= 110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are eligible for participation if they: have been diagnosed with either cervical, endometrial, or vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain their sexual activity on the short or long term. The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT. The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life, psychological distress, and relationship dissatisfaction. Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.

NCT ID: NCT03610724 Completed - Clinical trials for Non-Hodgkin Lymphoma

Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients

BIANCA
Start date: February 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia. For pediatric patients who have r/r B-NHL including Burkitt Lymphoma and Burkitt Leukemia, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

NCT ID: NCT03610360 Completed - Mesothelioma Clinical Trials

DENdritic Cell Immunotherapy for Mesothelioma

DENIM
Start date: June 21, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.

NCT ID: NCT03610035 Completed - Amyloidosis Clinical Trials

A Study of NPT189 in Healthy Subjects

Start date: July 24, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189 in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of NPT189.

NCT ID: NCT03609944 Recruiting - Pancreatitis Clinical Trials

SpHincterotomy for Acute Recurrent Pancreatitis

SHARP
Start date: September 27, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.

NCT ID: NCT03609775 Completed - Healthy Clinical Trials

A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

Start date: August 28, 2018
Phase: Phase 1
Study type: Interventional

A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects