TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02473601

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mivacurium Chloride
Description: Anesthesia induction:~Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes.~Anesthesia maintenance:~Two groups of sevoflurance 1%\~8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40 \~ 60. PetCO2 was 30 \~ 35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane.

Intervention type: DRUG
Group type: OTHER
Intervention: Mivacurium Chloride
Description: Anesthesia induction:~Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes.~Anesthesia maintenance:~Two groups of sevoflurance 1%\~8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40 \~ 60. PetCO2 was 30 \~ 35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane.
Study: NCT02212977

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Octylcyanoacrylate
Description: Skin incision closure with topic skin adhesive Octylcyanoacrylate

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Suture
Description: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Study: NCT06447896

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000)
Description: Cardiovascular autonomic reflex tests (CARTs) and heart rate variability analysis (HRV) are conducted with Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000). CARTs include five standardized tests, which are heart rate response to lying-to-standing, Valsalva maneuver, deep breathing, and blood pressure response to lying-to-standing and sustained isometric handgrip. These series of movements act as standardized stimuli to trigger hemodynamic changes in the body, altering vagal and sympathetic activity through mechanisms such as the baroreflex, thereby producing changes in heart rate and blood pressure. The sensor-monitoring interactive design of the device ensures the standardization of these maneuvers.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Conventional method of CARTs
Description: Conventional method are conduced using blood pressure kit with manual sphygmomanometer and ECG machine. Conventional method and the investigated device are used simultaneously to record electrocardiograms. Conventional blood pressure taking are carried out in sequence with the investigated device. CARTs results from the conventional method are used as control.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Ambulatory holter station Model i12 plus
Description: Model i12 plus (manufactured by RENCARE) is an ambulatory holter station, which was approved by the Center for Medical Device Evaluation (CMDE), China National Medical Products Association (NMPA). It can analyze electrocardiogram and generate HRV indices, which include SDNN, RMSSD, NN50, pNN50, triangular index, average RR, deceleration capacity (DC), deceleration runs (DRs), VLF, LF, HF, LF/HF, and total power. Model i12 plus is used to analyzed the same ECG signals as the investigated device.
Study: NCT01119222

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gabapentin
Description: Capsule, single 1200mg dose

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Diphenhydramine
Description: Tablet, single 50mg dose

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Morphine
Description: IV, single 10mg dose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
Study: NCT04077606

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ceramo-metallic crown prepartion
Description: tooth will be prepared to receive ceramo-metallic crowns

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ceramo-metallic crown prepartion
Description: tooth will be prepared to receive ceramo-metallic crowns

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: full anatomical monolithic zirconia crown
Description: tooth will be prepared to receive monolithic zirconia crowns

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: full anatomical monolithic zirconia crown
Description: tooth will be prepared to receive monolithic zirconia crowns
Study: NCT04063020

Intervention type: BEHAVIORAL
Intervention: Psychological monitoring
Description: Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.~* Before the first surgery (about 1 month before) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)~* Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person~* After the second surgery (15 months later the first surgery) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
Study: NCT03952650

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyrimethamine
Description: Pyrimethamine has been FDA approved for acute treatment and chemoprophylaxis of malaria due to susceptible strains of plasmodia.~Pyrimethamine has been shown to possess both liver and blood stage activity. In this study, we plan to use a higher dose of pyrimethamine, 75 mg orally for either one or two days each month. The pilot arms will receive either a total of 1 daily dose or 2 daily doses. The main arms will receive a total of 3 daily doses or a total of 6 doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Coartem
Description: Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Coartem
Description: Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Coartem
Description: Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.
Study: NCT01507389

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Single dose of 0.75 mg injected subcutaneously (under the skin)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Single dose of 0.75 mg injected subcutaneously (under the skin)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Single dose of 0.75 mg injected subcutaneously (under the skin)
Study: NCT03952650

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Coartem
Description: Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Coartem
Description: Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.
Study: NCT01507389

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Single dose of 0.75 mg injected subcutaneously (under the skin)
Study: NCT05045599

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
Description: Community engagement to improve awareness, and use of family planning products and services

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
Description: Community engagement to improve awareness, and use of family planning products and services
Study: NCT04220281

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol
Description: propofol infusion during surgery

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nitroglycerin
Description: nitroglycerin infusion during surgery
Study: NCT03904186

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: QUIT
Description: QUIT is a transdiagnostic Cognitive Behavioral Therapy-based smoking cessation protocol designed to address distress intolerance, anxiety sensitivity, and anhedonia in people living with HIV who smoke. QUIT is delivered in 9 60-minute individual weekly sessions over a 10-week period. Sessions are active, with treatment components practiced within and outside of the session. Participants will also receive the transdermal nicotine patch for 8 weeks, starting when they attempt to quit smoking during week 7 of the study.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Time-Matched Control (TM)
Description: Participants will receive a standard smoking cessation treatment, based on the clinical practice guidelines from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence. Treatment will be delivered in nine, 60-minute sessions over a ten-week period. The treatment is based on a treatment protocol developed and used previously by Dr. Zvolensky. Because clinical guidelines recommend that all smokers attempting to quit smoking receive pharmacotherapy, participants will also receive the transdermal nicotine patch for 8 weeks.
Study: NCT01436292

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5% human albumin solution (HAS)
Description: Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level:~≥ 30 gr/L: albumin will not be administered; 25 - 29.9 gr/L: 25 g of 5% HAS; 20 - 24.9 gr/L: 50 g 5% HAS; 15 - 19.9 gr/L: 75 g of 5% HAS; 10 - 14.9 gr/L: 100 g of 5% HAS; \< 10 gr/L: 150 g of 5% HAS.
Study: NCT02828085

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Nasal swab
Description: Nasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR
Study: NCT00288340

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: functional magnetic resonance imaging
Study: NCT00058370

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lomustine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: adjuvant therapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: iodine I 131 monoclonal antibody 3F8

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Study: NCT02203682

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxycycline hyclate
Description: Tab. Doxycycline 50 mg PO per day for 12 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Tablet placebo for 12 weeks
Study: NCT02127268

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Thymosin-α1
Description: with Thymosin-α1 1.6mg twice a week
Study: NCT00972647

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Laser beam guidance
Description: Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging
Study: NCT01142089

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).
Study: NCT04282928

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Human umbilical cord mesenchymal stem cells
Description: Definitive Human umbilical cord mesenchymal stem cells selected by immunomodulatory assay through coculture with BV2 cell

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Routine treatment
Description: According toInfluenza diagnosis and treatment plan (2019 version)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Routine treatment
Description: According toInfluenza diagnosis and treatment plan (2019 version)
Study: NCT00441740

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vinorelbine
Description: Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Study: NCT00519532

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rotigotine
Description: Rotigotine transdermal patches:~10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)~Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h
Study: NCT03703531

Intervention type: PROCEDURE
Intervention: Cardiopulmonary resuscitation
Description: CPR performed because of out-of-hospital cardiac arrest
Study: NCT00532259

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CT-011
Description: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Study: NCT00555945

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Gamma3 intramedullary nail (Stryker)
Description: The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Sliding Hip Screw
Description: The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
Study: NCT02663570

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melatonin
Study: NCT03701087

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin D
Description: 2800 IU daily till 26 weeks of pregnancy

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vitamin D
Description: 2800 IU daily till 26 weeks of pregnancy
Study: NCT00884000

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Genotropin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zomacton
Study: NCT01750281

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selumetinib 75 mg
Description: Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selumetinib 75 mg
Description: Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel 75 mg/m2
Description: Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel 75 mg/m2
Description: Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel 60 mg/m2
Description: Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Three placebo capsules will be administered orally uninterrupted twice daily.
Study: NCT01142089

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rifamycin SV MMX
Description: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).
Study: NCT01490398

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin
Description: After baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is \> 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year.
Study: NCT02915328

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Filterwire EZ™

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Filterwire EZ™

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MO.MA Ultra

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MO.MA Ultra

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Stent Roadsaver®

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Stent Roadsaver®

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Carotid Wallstent

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Carotid Wallstent
Study: NCT03175848

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Chemotherapy,radiotherapy
Description: Pelvic,pelvic-inguinal,or extended field radiotherapy：Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.
Study: NCT04891601

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: polypropelene mesh
Description: compare use mesh alone or combined mesh and darn repair

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: polypropelene mesh
Description: compare use mesh alone or combined mesh and darn repair
Study: NCT00404443

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Acupuncture
Description: Placebo-needles 17 will be used for those randomized to receive sham-acupuncture, which will be connected to the electrical current generator for the same duration and at the same acupuncture points without any current passing through, and intermittent non-specific manual twirling will also be applied. Patients are discouraged to communicate with each other before and after the treatment sessions to minimize bias.
Study: NCT02904564

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MMP with 5-FU
Description: MMP with 5-FU using tattoo device

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: MMP with Saline infusion
Description: MMP with saline infusion using tattoo device
Study: NCT02200107

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: self management education
Study: NCT00467883

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liposomal Amphotericin B
Description: high dosage
Study: NCT01742923

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Complex tailored intervention

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Usual care
Study: NCT02001350

Intervention type: OTHER
Intervention: Ultrasonography
Study: NCT03071432

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Paced breathing at 6, 10 and 15 breaths per minute

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Paced breathing at 6, 10 and 15 breaths per minute

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Paced breathing at 6, 10 and 15 breaths per minute
Study: NCT01652196

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: aflibercept
Description: 4 mg/kg as a 1-hour IV(intervenous) infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxaliplatin
Description: 85 mg/m2 IV infused over 2 hours
Study: NCT03197818

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CHF 5993 100/6/12.5 µg
Description: Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 160 µg budesonide + 4.5 µg formoterol fumarate
Description: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg
Study: NCT03059979

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.