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NCT ID: NCT03505801 Active, not recruiting - Atrial Fibrillation Clinical Trials

Confirm Rx Insertable Cardiac Monitor SMART Registry

Start date: April 24, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.

NCT ID: NCT03504397 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Spotlight
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

NCT ID: NCT03503773 Active, not recruiting - Hypertension Clinical Trials

The TARGET BP OFF-MED Trial

Start date: September 24, 2018
Phase: Phase 2
Study type: Interventional

To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.

NCT ID: NCT03502668 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

Start date: July 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.

NCT ID: NCT03499236 Active, not recruiting - Heart Failure Clinical Trials

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

RELIEVE-HF
Start date: September 19, 2018
Phase: N/A
Study type: Interventional

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

NCT ID: NCT03496038 Active, not recruiting - Clinical trials for Edentulous; Alveolar Process, Atrophy

Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with "the golden standard" DBBM, after trans-crestal sinus floor elevation.

NCT ID: NCT03495700 Active, not recruiting - Clinical trials for Edentulous; Alveolar Process, Atrophy

Lateral Sinus Floor Elevation in Implant Therapy.

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration. The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.

NCT ID: NCT03493685 Active, not recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

DUPLEX
Start date: April 17, 2018
Phase: Phase 3
Study type: Interventional

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

NCT ID: NCT03492177 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Start date: July 23, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

NCT ID: NCT03487900 Active, not recruiting - CD Clinical Trials

Is the Endoscopic Remission Evaluation, Using the CREDO 1 Index / Score in CD Patients in Clinical Remission at Baseline, Predictive of Sustained Clinical Remission Using a 2-year Follow up

CREDO2
Start date: March 13, 2018
Phase: N/A
Study type: Interventional

The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation, the predictive value of this remission evaluation needs to be tested in different settings to valorise its usefulness in clinical practice and in clinical trials. CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2 years. The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening period to include a patient is two weeks. Patients will be followed up to week 104.