TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02212483

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: First home intervention with advice
Description: A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: First home intervention without any advice
Description: A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Final home visit
Description: Final home visit at the end of the study after 12 months, with sampling and home audit.~For the intervention group, checking of the advice compliance. For the both comparative groups, delivery of advices.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Final home visit
Description: Final home visit at the end of the study after 12 months, with sampling and home audit.~For the intervention group, checking of the advice compliance. For the both comparative groups, delivery of advices.

Intervention type: OTHER
Group type: OTHER
Intervention: Final home visit
Description: Final home visit at the end of the study after 12 months, with sampling and home audit.~For the intervention group, checking of the advice compliance. For the both comparative groups, delivery of advices.
Study: NCT01284387

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ACC-001 (vanutide cridificar)
Description: Comparisons of 2 different doses of ACC-001 or placebo for 24 months

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ACC-001 (vanutide cridificar)
Description: Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Study: NCT03031574

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SUVN-D4010
Description: Tablets

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SUVN-D4010
Description: Tablets

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SUVN-D4010
Description: Tablets
Study: NCT04777669

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Noise Reduction
Description: In within subject design, listeners will have background noise removed by a noise reduction algorithm
Study: NCT04611737

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Interviewing
Description: Self-Determination Theory within motivational interviewing
Study: NCT03479593

Intervention type: DIAGNOSTIC_TEST
Intervention: CMR and OCT in NSTEMI patients with MVD
Description: Lesions \>50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography
Study: NCT01823640

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: placebo

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Human Rhinovirus strain 16 (HRV-16)
Description: 100 TCID50 dosis of HRV-16 will be inoculated on day 7 and / or day 0

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Human Rhinovirus strain 16 (HRV-16)
Description: 100 TCID50 dosis of HRV-16 will be inoculated on day 7 and / or day 0
Study: NCT00578318

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Motivational Interviewing Active
Description: Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational Interviewing Active
Description: Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
Study: NCT03556540

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: physical exercise
Description: Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: physical exercise
Description: Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.
Study: NCT03545321

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: MOON+
Description: MOON+ is an intervention to support the pharmacy and pharmacist to improve opioid safety and naloxone provision. Materials include educational trainings, materials for use with pharmacists, information for patients, and materials for standardizing overdose safety at the pharmacy
Study: NCT00475735

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK0249
Description: MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Concerta (methylphenidate)
Description: Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
Study: NCT03336073

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carfilzomib
Description: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carfilzomib
Description: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
Study: NCT02681445

Intervention type: DEVICE
Intervention: Breath Collection
Description: breath will be collected from patients in breath bag for analysis for observational study.

Intervention type: DEVICE
Intervention: Breath Collection
Description: breath will be collected from patients in breath bag for analysis for observational study.

Intervention type: DEVICE
Intervention: Breath Collection
Description: breath will be collected from patients in breath bag for analysis for observational study.
Study: NCT02503072

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Small lottery prizes based on adherence
Description: Clients coming for clinic visits have their MEMS data extracted, and if they show 95% adherence or higher are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Small lottery prizes based on timely clinic visits
Description: Clients coming for clinic visits have their patient booklet checked to confirm that they came on their scheduled day; if so, they are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.
Study: NCT02910570

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liraglutide 3 mg (Saxenda)
Description: Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks
Study: NCT02681445

Intervention type: DEVICE
Intervention: Breath Collection
Description: breath will be collected from patients in breath bag for analysis for observational study.

Intervention type: DEVICE
Intervention: Breath Collection
Description: breath will be collected from patients in breath bag for analysis for observational study.
Study: NCT02910570

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Liraglutide 3 mg placebo
Description: Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
Study: NCT04336462

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: oxyhydrogen
Description: Hydrogen-Oxygen Generator with Nebulizer Model: AMS-H-03 Gas production: 2.0 L/min, 2.5 L/min, and 3 L/min, three gears in total (in this study, the gas production of each machine is 3 L/min, two sets are connected and used together by three-way connection, and the total gas production is 6 L/min.) Manufacturer: Shanghai Asclepius Meditech Co., Ltd.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Oxygen
Description: oxygen inhaled,3 L/min . 6 hour a day.
Study: NCT02457832

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Adapted Tango Dancing
Description: Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms. Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics. Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music. Novel step elements will be introduced every class period. Those with PD will partner with an individual without PD. After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing. Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Adapted Tango Dancing
Description: Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms. Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics. Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music. Novel step elements will be introduced every class period. Those with PD will partner with an individual without PD. After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing. Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Behavioral Control (BC) Condition
Description: Group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.
Study: NCT02865759

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mindfetalness
Description: The pregnant woman is motivated to practice Mindfetalness verbally, by a brochure and at a website.
Study: NCT03106935

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Levothyroxine
Description: Levothyroxine is an orodispersible tablet.For the LT4 treatment group, 50μg LT4 (Merck Serono, Geneva,Switzerland) was administered every morning from the first day of diagnosed as subclinical hypothyroidism and continued up to the day of serum β-HCG measurement.If pregnancy was confirmed, levothyroxine dose need to increase 25-30% and adjusted according to the pregnancy specific reference range ( T1 0.1-2.5mIU/L,T2 0.2-3.0mIU/L, T3 0.3-3.0mIU/L) .
Study: NCT00715728

Intervention type: DEVICE
Intervention: Intraoperative warming with Bair Hugger forced air system
Description: Intraoperative warming with Bair Hugger forced air system
Study: NCT00141908

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 17-alpha Hydroxyprogesterone Caproate
Description: 250 mg IM weekly

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Castor oil
Description: weekly IM injections
Study: NCT04148521

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral Health - Virtual Patient Navigation
Description: Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention.
Study: NCT01644825

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: paclitaxel
Description: 80 mg/m2 IV days 1, 8, 15 every 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Description: 80 mg/m2 IV days 1, 8, 15 every 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pazopanib
Description: orally, 800 mg orally daily
Study: NCT01245335

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: BMAC injection
Description: Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Placebo injection
Description: Injection of placebo into ischemic tissue of the lower extremity
Study: NCT00629551

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: saredutant (SR48968)
Description: oral administration,capsules
Study: NCT00715728

Intervention type: DEVICE
Intervention: Intraoperative warming with Hotdog resistive heating system
Description: Intraoperative warming with Hotdog resistive heating system
Study: NCT00629551

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: saredutant (SR48968)
Description: oral administration,capsules

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: paroxetine
Description: oral administration, capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paroxetine
Description: oral administration, capsules

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paroxetine
Description: oral administration, capsules

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: oral administration, capsules

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: oral administration, capsules
Study: NCT01329185

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valganciclovir
Description: Valganciclovir 450mg twice a day for 14 days prior to transplant date

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1 capsule twice a day for 14 days prior to transplant date
Study: NCT01527903

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol infusion
Description: IV propofol 2% at a rate of 1.0 mg kg-1 h-1, increments or decrements of 0.1 mg kg-1 h-1

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam infusion
Description: midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1
Study: NCT00212797

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Org 34517
Description: low dose Org 34517

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Org 34517
Description: high dose Org 34517

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo
Study: NCT00002621

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: recombinant interferon alfa
Study: NCT01076322

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meptin® Swinghaler
Description: Meptin® Swinghaler®~* Ingredient: Procaterol HCL~* Dosage form: 10g/puff~* Dose(s): 10g~* Dosing schedule: 20g (total 20g)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meptin® Swinghaler
Description: Meptin® Swinghaler®~* Ingredient: Procaterol HCL~* Dosage form: 10g/puff~* Dose(s): 10g~* Dosing schedule: 20g (total 20g)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ventolin® MDI
Description: Ventolin® MDI~* Ingredient: Salbutamol sulfate~* Dosage form: 100g/puff~* Dose(s): 100g~* Dosing schedule: 200g (total 200g)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ventolin® MDI
Description: Ventolin® MDI~* Ingredient: Salbutamol sulfate~* Dosage form: 100g/puff~* Dose(s): 100g~* Dosing schedule: 200g (total 200g)
Study: NCT03436030

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Simple breathing manuevers during brief echocardiographic imaging
Description: Valsalva, Muller, light mask CPAP, leg raising, hand grip.
Study: NCT00245440

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azithromycin
Description: 250 mg tablets; 2 tablets once daily (500 mg) for 3 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Telithromycin
Description: 400 mg tablets; 2 tablets once daily (800 mg) for 5 days
Study: NCT03175198

Intervention type: DRUG
Intervention: Prazaxa® Capsules
Description: Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg \[as 2 capsules of 75 mg\] twice a day (b.i.d)) or 220 mg (110 mg \[as 1 capsule of 110 mg\] b.i.d) for a treatment duration of 52 weeks.
Study: NCT04313790

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Infusion
Description: 500 unit heparin infusion \\ hour for DVT prophylaxis experimental group (n=20)

Intervention type: OTHER
Group type: OTHER
Intervention: subcutaneous heparin
Description: 5000 unit subcutaneous heparin /8 hours control group n=(20)
Study: NCT02201771

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ticagrelor

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ticagrelor
Study: NCT02716753

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: seminal plasma

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Physiological NaCL solution
Study: NCT02960126

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clopidogrel
Study: NCT02437032

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: recombinant FSH
Description: Controlled ovarian stimulation with 150-300 UI recombinant FSH

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Urinary FSH
Description: Controlled ovarian stimulation with 150-300 UI urinary FSH

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: hMG
Description: Controlled ovarian stimulation with 150-300 UI hMG
Study: NCT00189852

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Chronic heart failure monitoring system

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Lifestyle monitoring system
Study: NCT02425722

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP0456
Description: oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP0456
Description: oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP0456
Description: oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP0456
Description: oral

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: oral
Study: NCT03724851

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEW-7197
Description: Vactosertib will be administered orally without regard to meals for 5 days per week (5D/W) at the same time in the morning (QD), at the same time in the morning and evening (BID) approximately 12 hours apart.~Pembrolizumab will be administered as a dose of 200 mg using a 30-minute IV infusion. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEW-7197
Description: Vactosertib will be administered orally without regard to meals for 5 days per week (5D/W) at the same time in the morning (QD), at the same time in the morning and evening (BID) approximately 12 hours apart.~Pembrolizumab will be administered as a dose of 200 mg using a 30-minute IV infusion. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TEW-7197
Description: Vactosertib will be administered orally without regard to meals for 5 days per week (5D/W) at the same time in the morning (QD), at the same time in the morning and evening (BID) approximately 12 hours apart.~Pembrolizumab will be administered as a dose of 200 mg using a 30-minute IV infusion. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.
Study: NCT02567409

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

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

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

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine Hydrochloride
Description: Given IV
Study: NCT04258969

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pedaling
Description: Participants will pedaling at a low-moderate intensity using a stationary pedal ergometer concurrent to their chemotherapy (FOLFOX or FOLFIRI) infusion. Participants will cycle for 30 min within the first 2 hours of their infusion.
Study: NCT00430352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rituximab [MabThera/Rituxan]
Description: 375mg/m2 iv every 8 weeks
Study: NCT03713840

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Healthy Beverages in Child Care
Description: 12-week intervention promoted consumption of healthy beverages (water, unsweetened low-fat milk) and discouraged consumption of unhealthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multi-pronged intervention was delivered via child care centers, targeted children, parents, and child care staff, and included education, environmental changes, and policies.
Study: NCT00653302

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lantus (insulin glargine) + Glucophage (Metformin)