Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).

Patients will receive the same dose of placebo.

Reperfusion Injury, Myocardial

Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min.
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).

melatonin (Helsinn Chemical Co, Biasca, Switzerland)

The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).

Placebos

PLA General Hospital

Effects of Melatonin on Reperfusion Injury

Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

The salvage index measured by cardiac magnetic resonance

The final infarct size measured by cardiac magnetic resonance

recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.

Chen Wei Ren, MD

doctor

Chinese PLA General Hospital

Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

patients undergoin transcatheter aortic valve implantation

patient undergoing diagnostic coronary angiography

Transcatheter Aortic Valve Implantation Prosnosis and Complications

patients will be asked for a venous blood sample

venous blood withdrawl

Tel Aviv Medical Center

Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement

Tryptase Levels as a Marker of Mast Cell Activity and the Prognostic Implication in Patients Post Transcatheter Aortic Valve Replacement

Post procedural complications - major stroke, acute kidney injury, paravalvular regurgitation, permanent pacemaker implantation, coronary artery obstruction, heart block, vascular injury, pericardial hemorrhage

Only the principle investigator will have access to IPD

Tel-Aviv Sourasky Medical Center

45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

NonHodgkin Lymphoma

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Standard Arm

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Experimental Arm

Tata Memorial Center

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.

From the time of randomization till relapse or progression or death due to any cause or death due to disease.
Assessment by physiological parameter

From the time of randomization till the disease is controlled at the site of radiation.
Assessment by physiological parameter.

From the time of randomization to death due to any cause /death due to disease. assessment by physiological parameter

Jayant Sastri Goda

Associate Professor

Tata Memorial Hospital

subcutaneous Granulocyte - Colony Stimulating Factor ( on top of optimal standard of care) and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Patients will be receive optimal standard of care and Myocardial Contrast Echocardiography with intravenous infusion of sulphur hexafluoride.

Anterior Myocardial Infarction

Heart Failure

rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously

rhu G-CSF

optimal standard of care

Myocardial Contrast Echocardiography with sulphur hexafluoride.

Myocardial Contrast Echocardiography

Fondazione Policlinico Universitario Agostino Gemelli

RIGENERA 2.0 Trial

RIGENERA 2.0 (Recupero Dall'Infarto Miocardico Con G-CSF E Nuovi Esempi di Rigenerazione Avanzata) Project: "The Combined Effect of Subcutaneous Granulocyte - Colony Stimulating Factor and Myocardial Contrast Echocardiography With Intravenous Infusion of Sulphur Hexafluoride on Post-infarction Left Ventricular Function"

Left ventricular ejection fraction (LVEF) at 6 months assessed by Cardiac Magnetic Resonance and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by Cardiac Magnetic Resonance at 6 months and centrally reviewed

Left ventricular ejection fraction (LVEF) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-diastolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Left ventricular end-systolic volume (LVEDV) assessed by 2D Echocardiography at 6 months and centrally reviewed

Clinical Major adverse cardio-cerebrovascular events (death, myocardial infarction, stroke and rehospitalization due to heart failure) at 1 year

Antonio Maria Leone, MD

MD, PhD

Catholic University of the Sacred Heart

The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.

Ofatumumab

Sex: Female, Male

Region of Enrollment

OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients.
A CR is defined as:
Disappearance of all disease.
If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative
If the nodal masses were Variably or PET negative; they must regress to normal.
No palpable liver or spleen
Palpable nodal masses are no longer palpable
Negative bone marrow biopsy
A PR is defined as:
Regression of measurable disease and no new sites of disease.
> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required.
No increase in the size of the liver or spleen

Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.

Overall Response (OR)

OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1
SD is defined as:
Failure to attain CR/PR or Progressive Disease (PD)
PET remains positive.
PD is defined as:
Any new lesion > 1.5 cm in longest axis
An increase 50% or more of previously involved sites from nadir
50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is > 1 cm in shortest axis
PET remains positive if it was positive before therapy.

The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.

lactate dehydrogenase/infarkt

Effects of Melatonin on Reperfusion Injury

Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.

RIGENERA 2.0 Trial

Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas

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