TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02871674

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Good Night Project
Description: The behavioural interventions have been designed on the basis of three sources. Firstly, a systematic review conducted by the research team that examined the best evidence in the field in different countries. Secondly, a Delphi study, which aimed to identify behavioural interventions that can be used to manage sleep difficulties in Saudi Arabia in accordance with professionals' views and primary caregivers' needs, and which was also conducted by the research team. Thirdly, evidence-based practice resources that help in understanding and managing sleep difficulties will be translated into Arabic.
Study: NCT01816321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Corifollitropin alfa
Description: Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: recombinant FSH
Description: recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ganirelix
Description: Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ganirelix
Description: Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: hp HMG
Description: hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering
Study: NCT00920153

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bleomycin sulfate
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bleomycin sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABVD regimen
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABVD regimen
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carmustine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carmustine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carmustine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dacarbazine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dacarbazine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ifosfamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: melphalan
Description: Given IV
Study: NCT00547014

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Comparator: Cohort 1 Placebo
Description: Drug: placebo for cohort 1 as single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 52364 3 mg
Description: 3 mg capsule single dose administered orally as a single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo
Description: Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 52364 10 mg
Description: Drug: 52364 30 mg capsule as a single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 52364 30 mg
Description: Drug: 52364 30 mg capsule administered as a single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 52364 100 mg
Description: Drug 52364 100 mg capsule administered as a single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 52364 1 mg
Description: 1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose
Study: NCT00920153

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methylprednisolone
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methylprednisolone
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methylprednisolone
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mitoguazone
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vindesine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vindesine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vindesine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vinorelbine tartrate
Description: Given IV
Study: NCT00570284

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LBH589
Description: orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)
Study: NCT05102877

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Neuromuscular electrical stimulation
Description: Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.
Study: NCT00920153

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: allogeneic hematopoietic stem cell transplantation
Description: Patients undergo allogeneic stem cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: autologous hematopoietic stem cell transplantation
Description: Patients undergo autologous stem cell transplantation
Study: NCT01551966

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Wireless esophageal capsule endoscopy ( PillCam Eso2)
Description: This is a simple blind (blind for the lecture of the capsule endoscopy record) study to evaluate the diagnostic value of the capsule endoscopy for the detection and the control of esophageal varices, the feasibility, tolerance and safety of the capsule endoscopy compared to the conventional EGD under general sedation in children presenting with portal hypertension.~During one week, the patients will undergo two exams (capsule endoscopy and EGD under general sedation). The exams will be done by two different physicians.~For to asses the tolerance, after they completed both exams, the patients will be asked to answer a comfort score questionnaire.~In order to asses the safety of the capsule endoscopy, the patients will be followed for adverse events during 3 weeks after the completion of the capsule endoscopy.
Study: NCT02427841

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluorouracil
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Given IV

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Image Guided Radiation Therapy
Description: Undergo IG-IMRT

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-Modulated Radiation Therapy
Description: Undergo IG-IMRT

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nab-paclitaxel
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Conventional Surgery
Description: Undergo surgery
Study: NCT00747227

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: modified light transmission intraocular lens
Description: violet visible light blocking acrylic intraocular lens
Study: NCT03151382

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tandospirone Citrate
Description: Tandospirone, 30-60 mg/d

Intervention type: DRUG
Group type: OTHER
Intervention: Donepezil Hydrochloride
Description: Donepezil, 10 mg/d
Study: NCT00747227

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: monofocal acrylic intraocular lens
Description: conventional hydrophobic acrylic intraocular lens
Study: NCT02895204

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fermented Maillard reacted whey protein (F-MRP)
Description: 6g of powder containing 4.2g fermented maillard reacted whey protein
Study: NCT03151382

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Donepezil Hydrochloride
Description: Donepezil, 10 mg/d
Study: NCT03366857

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxygen 30 %
Description: The oxygen concentration will be set at 30%.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxygen 80 %
Description: The oxygen concentration will be set at 80%.
Study: NCT04238936

Intervention type: DIAGNOSTIC_TEST
Intervention: Serum amyloid A values
Description: Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Intervention type: DIAGNOSTIC_TEST
Intervention: Serum amyloid A values
Description: Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Intervention type: DIAGNOSTIC_TEST
Intervention: Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)
Description: Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.
Study: NCT01484080

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBF + Paclitaxel
Description: Priming Period:~Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel, on a continuous schedule for 14 days.~One week washout is planned before starting the treatment phase.~Treatment Phase:~Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 + BIBF 1120 recommended dose bid po days 1-21 q 21 days. (BIBF 1120 morning dose is skipped on the paclitaxel administration days).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 q 21 days. A total of 4 cycles will be administered in both arms.
Study: NCT01735318

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lisinopril Tablets 40 mg
Description: 40 mg tablet once a day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lisinopril
Description: 40 mg tablet once a day
Study: NCT01359930

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: matching placebo

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naltrexone and Bupropion SR
Description: 25mg bid/day (NX) 200mg bid/day (BUP)
Study: NCT03400527

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Participants will pedal on a stationary bicycle up to 25 minutes 2-3 times a week for 4 weeks at a self directed pace and intensity
Study: NCT02133430

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Bispectral index, as measured by a BIS processor
Description: Comparisons of incidence of postoperative delirium.
Study: NCT05438277

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone (MPA)
Description: injection into subacromial or glenohumeral space with MPA

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Triamcinolone Acetonide (TA)
Description: injection into subacromial or glenohumeral space with TA
Study: NCT04564911

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Flash Glucose Monitoring and Education
Description: Participants will wear the flash glucose monitoring system, and receive an education package on how to self-manage their glucose levels. They will use the flash glucose monitoring system continuously for 6 weeks. From week 6 to week 24, the frequency of use of flash glucose monitoring will be reduced to one sensor every 4 weeks. They will receive education at weeks 0, 2, 8 and 16. They will also wear a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: Capillary glucose monitoring and Education
Description: Participants will use a capillary glucose meter and receive an education package on how to self-manage their glucose levels. Participants will be encouraged to test their blood glucose levels at least twice a day, but preferably 4 times daily: pre-meal and bedtime blood glucose levels. They will receive education at weeks 0, 2, 8 and 16. They will wear a blinded sensor again after the last 2 weeks of the intervention period (week 24 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.
Study: NCT02979821

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Poziotinib
Description: A cycle of study treatment is defined as 28 days.
Study: NCT01047280

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Clarinol G-80 ® treatment
Description: dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Safflower oil
Description: 3.5 g/d of safflower oil

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: G-c9, t11
Description: 3.5 g/day of c9, t11 CLA
Study: NCT04936503

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Resting electrocardiogram
Description: An ECG at rest is performed for all participants at Day 0. A centralized reading is performed by one of the 6 expert cardiologists participating in the research.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Stress test
Description: In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a stress test is performed.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Cardiac echocardiography
Description: In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac echocardiography is performed.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Cardiac rhythm monitoring
Description: In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac rhythm monitoring is performed.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire
Description: To determine the rhythmic risk of athletes

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Injected Cardiac MRI
Description: High resolution MRIs is performed on 200 athletes :~* 100 athletes without rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)~* 100 athletes with rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood sampling for biobank
Description: For all athletes included at the D0 inclusion visit, a centralized COVID-19 serology is performed to search for biomarkers associated with the occurrence of myocardial fibrosis: analysis of genetic determinants in relation to cardiac damage.~For athletes who have performed MRI: Search for biomarkers associated with the occurrence of myocardial fibrosis: analyses of low-grade inflammation markers (cytokine assay and fibrosis markers).
Study: NCT02895204

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 6g of maltodextrin
Study: NCT01124383

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: General anesthesia
Description: For women in the general anesthesia group, general anesthesia is induced using midazolam 1-3 mg, sufentanil 0.15-0.25 mcg/kg and propofol 1-3 mg/kg. Rocuronium 0.6 mg/kg is allowed. Anesthesia is maintained with sevoflurane titrated to maintain a blood pressure within 20% of preoperative normal and, if needed, ephedrine can be used for this purpose. Patients are ventilated in a normocapnic range with a positive end-expiratory pressure of 3 to 5 mmHg.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Local anesthesia with sedation
Description: For women in the local anesthesia group a paracervical block is performed by the gynecologist using a total of 20 mL of 1% lidocaine intracervically at 2, 4, 7 and 10 o'clock positions and in the area of uterosacral ligaments. Once the block completed, the surgeon waits at least five minutes before performing cervical dilatation to allow for sufficient analgesia. Intravenous sedation consists of midazolam, sufentanil and propofol administered by the anesthesiologist in sufficient doses to maintain a spontaneous ventilation with a Ramsay score \< 4.
Study: NCT03683992

Intervention type: DEVICE
Intervention: Triathlon total knee system
Description: Implantable
Study: NCT01115127

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: melatonin
Description: 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: myo-inositol
Description: 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: melatonin plus myo-inositol
Description: 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
Study: NCT02260713

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: autologous bone marrow cell
Description: Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: autologous bone marrow cell
Description: Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.
Study: NCT00082875

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cilengitide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cilengitide
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT02120001

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ETT cleaning maneuver
Description: EndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions.~We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.
Study: NCT03969680

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Auotologous BMSCs plus autologous PRP
Description: 30 mL of bone marrow will be aspirated from the iliac crests of patients in case group. BMSCs will be isolated from bone marrow and cultured. Before injection, 30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Auotologous PRP
Description: 30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
Study: NCT04606186

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)
Description: Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo-lozenges (BioGaia)
Description: Placebo-lozenges (BioGaia)
Study: NCT00777738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BORTEZOMIB
Description: * Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push).~* For responding patients : up to 6 cycles~* For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days