TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00368277

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aliskiren
Description: Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ramipril
Description: Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrochlorothiazide
Description: Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrochlorothiazide
Description: Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine
Description: Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amlodipine
Description: Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
Study: NCT02241603

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Weight loss
Description: Obese Veterans will undergo dietary education for weight loss or weight maintenance
Study: NCT01484821

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: ARFI
Description: Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: ARFI
Description: Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ARFI
Description: Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
Study: NCT01852513

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: QNASL

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo nasal spray
Study: NCT00748163

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel albumin-stabilized nanoparticle formulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib malate
Study: NCT04008888

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation
Description: Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2
Description: Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan Given IV
Description: conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m\^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan Given IV
Description: conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m\^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine Injection
Description: conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PI and dexamethasone as maintenance therapy
Description: Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PI and dexamethasone as maintenance therapy
Description: Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PI and dexamethasone as maintenance therapy
Description: Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PI+IMids+Dexamethasone as Consolidated Chemotherapy
Description: Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11\&12 of each 21-day.
Study: NCT03853395

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Tests for drug levels and anti-drug antibodies
Description: Measurement of drug levels and anti-drug antibodies will be undertaken using commercially available enzyme-linked immunosorbent assays (ELISAs) and/or radioimmunoassays

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Tests for drug levels and anti-drug antibodies
Description: Measurement of drug levels and anti-drug antibodies will be undertaken using commercially available enzyme-linked immunosorbent assays (ELISAs) and/or radioimmunoassays
Study: NCT04221945

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: IV infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for pembrolizumab
Description: IV infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: IV infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: IV infusion

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: External Beam Radiotherapy (EBRT)
Description: Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: External Beam Radiotherapy (EBRT)
Description: Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Brachytherapy
Description: Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Brachytherapy
Description: Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Study: NCT01660607

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CD34+ Hematopoietic Progenitor Cells (HSPC)
Description: Purified CD34+ hematopoietic progenitor cells used in transplantation.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CD34+ Hematopoietic Progenitor Cells (HSPC)
Description: Purified CD34+ hematopoietic progenitor cells used in transplantation.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CD34+ Hematopoietic Progenitor Cells (HSPC)
Description: Purified CD34+ hematopoietic progenitor cells used in transplantation.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Regulatory T-Cells (Treg)
Description: Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Regulatory T-Cells (Treg)
Description: Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Regulatory T-Cells (Treg)
Description: Highly purified CD4+CD25+CD127-FoxP3+ regulatory T cells to reduce graft-versus-host disease.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Conventional T-Cells (Tcon)
Description: Conventional CD3+ T cells used for immune reconstitution and graft enhancement.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Conventional T-Cells (Tcon)
Description: Conventional CD3+ T cells used for immune reconstitution and graft enhancement.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Conventional T-Cells (Tcon)
Description: Conventional CD3+ T cells used for immune reconstitution and graft enhancement.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Myeloablative Conditioning Regimen
Description: Chemotherapy or total body irradiation used before hematopoietic cell transplantation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Myeloablative Conditioning Regimen
Description: Chemotherapy or total body irradiation used before hematopoietic cell transplantation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Myeloablative Conditioning Regimen
Description: Chemotherapy or total body irradiation used before hematopoietic cell transplantation.
Study: NCT01368523

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nilotinib
Study: NCT04531332

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Continuous infusion Linezolid
Description: Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: intermittent dosing linezolid
Description: Linezolid 600 mg intravenous twice daily
Study: NCT03300440

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Probiotics and vitamin B7
Description: Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form (7,5 x 109 CFU) Bacteria strains: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactobacillus acidophilus W22 Lactobacillus casei W56 Lactobacillus paracasei W20 Lactobacillus plantarum W62 Lactobacillus salivarius W24 Lactococcus lactis W19 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo and vitamin B7
Description: Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes
Study: NCT01463800

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Structured exercise training
Description: 12 weeks low level ambulatory structured exercise training
Study: NCT02996890

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MV-ZIKA
Description: MV-Zika vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MV-ZIKA
Description: MV-Zika vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MV-ZIKA
Description: MV-Zika vaccine

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: physiological saline

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: physiological saline
Study: NCT03665181

Intervention type: OTHER
Intervention: use or non-use of dose modulator and bismuth mask
Description: For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

Intervention type: OTHER
Intervention: use or non-use of dose modulator and bismuth mask
Description: For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

Intervention type: OTHER
Intervention: use or non-use of dose modulator and bismuth mask
Description: For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

Intervention type: OTHER
Intervention: use or non-use of dose modulator and bismuth mask
Description: For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask
Study: NCT02106065

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Education and Skill-Building Rehabilitation (ESBR)
Description: ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Education and Skill-Building Rehabilitation (ESBR)
Description: ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Supplemental Education Materials
Description: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Study: NCT03696381

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Real tRNS
Description: The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. During the first 20 minutes of each cognitive training session, patients will receive bi-frontal and bi-parietal tRNS. It has a start and end ramp of two seconds in each case to avoid the slight unpleasant sensation that occurs in the first moments of the introduction of direct current DC.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Sham tRNS
Description: The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. We will apply a sham tRNS for the first 20 minutes of each cognitive training session. The subjects will receive sham tRNS and will perform the same type of cognitive training as the rest of patients and will receive the same type of adverse reaction questionnaire. Subjects receiving simulated stimulation will receive the same type of ramps at the beginning and end of the session to ensure triple-blind maintenance .
Study: NCT00836836

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Modified Atkins diet
Description: Modified Atkins Diet administration~1. Carbohydrates intake will be restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)~2. Fats (e.g. cream, butter, oils, ghee) encouraged.~3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.~4. Clear carbohydrate-fluids not restricted.~5. Calcium and multivitamin supplementation will be provided.
Study: NCT01801670

Intervention type: PROCEDURE
Intervention: Biopsy
Description: Two 6 mm skin punch biopsies (one from pruritic skin and from involved non pruritic skin).

Intervention type: PROCEDURE
Intervention: Blood
Description: Peripheral blood (10 mls) to be drawn and used for cytokine analysis.
Study: NCT01107236

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IW-6118
Description: Single dose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Matching Placebo
Description: Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naproxen Sodium
Description: Single dose
Study: NCT02149303

Intervention type: DRUG
Intervention: Dabigatran 75 mg
Description: PO BID

Intervention type: DRUG
Intervention: Dabigatran 150 mg
Description: PO BID
Study: NCT00090038

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rituximab
Description: Dose, schedule,and duration specified in protocol
Study: NCT02207309

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pazopanib

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (for Pazopanib)
Study: NCT04324008

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Constic
Description: Flowable resin composite

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: G-ænial Universal Flo
Description: Flowable resin composite

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tetric N-Flow (self-etch)
Description: Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tetric N-Flow (etch&rinse)
Description: Tetric N-Flow (Tetric N-Bond Universal, etch\&rinse mode)
Study: NCT01660607

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Myeloablative Conditioning Regimen
Description: Chemotherapy or total body irradiation used before hematopoietic cell transplantation.
Study: NCT01462110

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 19416-154-1
Description: 0.15% ethyl lauroyl arginate HCl-containing mouthrinse

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: W002194-0221P
Description: 5% hydroalcohol mouthrinse
Study: NCT02454751

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fentanyl
Description: One time dose of 50mcg of fentanyl administered intranasally
Study: NCT04200547

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Immunomonitoring-based follow-up
Description: Post-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured:~* If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study.~* If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard follow-up
Description: Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI \> 220 together with an increase of 70 points) and biological relapse (CRP \> 10mg/mL and fecal calprotectin \> 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week.
Study: NCT01712139

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan and Hydrochlorothiazide

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Avalide
Study: NCT03112486

Intervention type: PROCEDURE
Intervention: blood draw
Description: Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL).

Intervention type: PROCEDURE
Intervention: blood draw
Description: Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL).
Study: NCT00656175

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: raltegravir
Description: raltegravir

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: raltegravir
Description: raltegravir
Study: NCT02360787

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Energy restriction

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Energy restriction

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Almonds (15% kcal/day)
Study: NCT02980406

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: FODMAP
Description: Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: FODMAP
Description: Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: FODMAP
Description: Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Glucose (control)
Description: Glucose is not a FODMAP.
Study: NCT01537848

Intervention type: PROCEDURE
Intervention: EUS guided transmural drainage
Description: Puncture of the collection is done under EUS guidance using a linear echoendoscope (FG-3830UT, Pentax or Olympus GF-UCT140/180 or forward viewing scope (Olympus)) with a 19G echoTip needle or a cystotome (Cook Medical Inc.). Then a 0.035 guidewire is inserted in the collection and the hole is enlarged with a cystotome (Cook Medical) or a 6.5F diathermic sleeve (Endoflex) and sometimes if needed a 6-8mm CRE balloon (Boston Scientific) before stenting with one or two double pigtail plastic stents (Cook Endoscopy, Endoflex). A nasocystic drain was also put whenever needed. If only a single stent could be placed in the first attempt, a subsequent procedure is scheduled for insertion of additional stents after dilation of the tract. There isn't any specific drug given during the procedure.
Study: NCT02130388

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Zinc

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Zinc
Study: NCT03135509

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CC-220
Description: CC-220 gelatin capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CC-220
Description: CC-220 gelatin capsules
Study: NCT02118779

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioural change intervention
Description: The intervention is cognitive behaviour therapy (CBT). The CBT consists of six different modules. All patients will start with individual goal setting and psycho-education about the role of cognitive-behavioural variables in the disabilities patients' experience. The patient formulates his or her treatment goals in concrete terms and later on in the therapy the goals are realised step by step by the patient. The treatment is tailored to the patient's problems: which of the six modules a patient will receive is dependent on the scores on measures that have been collected at baseline assessment. Based on our previous experience with modular interventions we expect that most patients will receive less than four modules.
Study: NCT04536805

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy)
Description: Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5 x 6 Gy day 0 to day 10

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation Therapy (SBRT) 36 Gy
Description: Stereotactic Body Radiation Therapy (SBRT): Dose escalation 6 x 6 Gy day 0 to day 12

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation Therapy (SBRT) 25 Gy
Description: Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5x 5 Gy day 0 to day 10