AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01509599 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cryotherapy: Cooling gel wrap
Description: Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy: cooling gel wrap during the home-based intervention
Study NCT01509599 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Usual care
Description: Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy wrap (sham) during the home-based intervention
Study NCT00546377 — intervention group
Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: polymerase chain reaction
Study NCT00546377 — intervention group
Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: protein expression analysis
Study NCT00546377 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: flow cytometry
Study NCT00546377 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: biopsy
Study NCT02074423 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: MealShape cinnamon extract
Description: Acute administration of 1 g PO (2 capsules of 500 mg)
Study NCT04169139 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MIST (minimally invasive surgical therapy)
Description: REPaiR Periodontal Therapy
Study NCT02635711 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Adapted Taekwondo training
Description: Adapted Taekwondo training for beginners
Study NCT02635711 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Control
Description: Daily jogging
Study NCT03030053 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Cocoa-Flavanol Supplements
Description: 3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).
Study NCT04169139 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MIST (minimally invasive surgical therapy)
Description: REPaiR Periodontal Therapy
Study NCT02173977 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ARM A- Agonist/Antagonist protocol
Description: In vitro fertilization (IVF/ICSI)
Study NCT02173977 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ARM B- Antagonist protocol
Description: In vitro fertilization (IVF/ICSI)
Study NCT03044301 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: OTHER
Intervention: Intramuscular ZENEO® injection
Description: Sodium Chloride (0.9 %)
Study NCT03044301 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: OTHER
Intervention: Subcutaneous high ZENEO® injection
Description: Sodium Chloride (0.9 %)
Study NCT03044301 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: OTHER
Intervention: Subcutaneous low ZENEO® injection
Description: Sodium Chloride (0.9 %)
Study NCT04303897 — intervention group
Intervention type: DEVICE
Intervention: XEN Glaucoma Stent
Description: Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan
Study NCT04227782 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Magnetic Resonance Imaging
Description: Magnetic Resonance Imaging
Study NCT04227782 — intervention group
Intervention type: OTHER
Intervention: Stable Isotope Study
Description: Stable Isotope study
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Study NCT04213196 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HSK21542
Description: Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Study NCT04520984 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Integrated ambulatory palliative and nephrology care
Description: Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months.~The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study.
Study NCT04520984 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Standard nephrology care
Description: Standard nephrology care
Study NCT01994330 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: desmopressin
Description: 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Study NCT01994330 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: desmopressin
Description: 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Study NCT04210453 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin C
Description: Participants in Vitamin C group are administered IV vitamin C diluted in 100 cc normal saline 1 day before surgery, at rewarming during surgery, 3 hours after surgery, and every 6 hours thereafter until postoperative 24 hours.
Study NCT03030053 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Control Supplements
Description: 3 capsules each containing 0mg cocoa-flavanols
Study NCT03715413 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.
Description: Patients were lying prone. Firstly, T2, 3, 4 disc level was detected then the target 2nd, 3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by 2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve roots.The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of 1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.
Study NCT04210453 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Control (Normal saline)
Description: Participants in Control group are administered IV 100cc normal saline at the same timepoint as above.
Study NCT04916223 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Therapeutic massage
Description: The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid therapist effect as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm.
Study NCT04916223 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Therapeutic massage
Description: The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid therapist effect as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm.
Study NCT02930239 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Gait rehabilitating with reduced bodyweight
Description: Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.
Study NCT03715413 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tamoxifen
Description: received Tamoxifen 10 mg daily
Study NCT03715413 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Tamoxifen
Description: received Tamoxifen 10 mg daily
Study NCT03029234 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 20 mg intravenous (IV) or oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23 in 28-day cycles.
Study NCT03029234 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carfilzomib
Description: Infusion of IV carfilzomib on days 1, 2, 8, 9, 15 and 16 in each 28-day cycle.
Study NCT02930239 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
Description: Exercises for increased movement and circulation performed on a daily basis.
Study NCT02930239 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
Description: Exercises for increased movement and circulation performed on a daily basis.
Study NCT00680212 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: dietary carotenoids
Description: spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene 0.5 mg oil capsule
Study NCT00680212 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: spinach, rice, and synthetic beta-carotene
Description: spinach containing 1 - 2 mg beta-carotene rice containing 0.5 mg beta-carotene synthetic beta-carotene, 0.5 mg oil dose
Study NCT02074423 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Acute administration of 1 g PO (2 capsules of 500 mg)
Study NCT04349228 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxychloroquine (HCQ)
Description: Hydroxychloroquine (HCQ) 200mg/day
Study NCT04349228 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral tablet
Description: Placebo of Hydroxychloroquine (HCQ) without any active substance
Study NCT01883726 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Grayson's presurgical nasoalveolar molding
Description: Grayson NAM
Study NCT01883726 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Figueroa's presurgical nasoalveolar molding
Description: Figueroa NAM
Study NCT01275573 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Repetitive Transcranial Magnetic Stimulation
Description: Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
Study NCT04029922 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MT-5111 (experimental study drug)
Description: Experimental treatment with MT-5111
Study NCT03850769 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nab-paclitaxel and S-1
Description: Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area \< 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 \< 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;
Study NCT02265900 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: One type of exercise
Study NCT02265900 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Exercise
Description: A different type of exercise
Study NCT02242747 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: ingenol mebutate
Description: an application a day for three consecutive days in a pre-determined area
Study NCT02242747 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: 5% 5-FU
Description: two applications a day for four weeks in a pre-determined area
Study NCT00342862 — intervention group
Intervention type: DRUG
Intervention: Amevive exposure
Description: Observational
Study NCT04637412 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Menu label
Description: Participants will be shown a sample of items from a restaurant menu, displayed with labels
Study NCT00891267 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olmesartan medoxomil tablets low dose
Description: Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Study NCT00891267 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olmesartan medoxomil tablets high dose
Description: Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Study NCT00891267 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amlodipine
Description: Amlodipine tablets taken once daily for 6 weeks
Study NCT03600337 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Working to Optimize Wellness in Tees with PCOS (WOW)
Description: 5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention
Study NCT02534909 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LFG316
Description: LFG316 20 mg/kg was administered to all patients enrolled in the study:~* Treatment Periods 1 to 3: LFG316 20 mg/kg as i.v. infusion every 2 weeks~* Treatment Period 4: LFG316 20 mg/kg as i.v. infusion every 2 weeks for 4 weeks (total 2 infusions).
Study NCT02534909 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LNP023
Description: Treatment Period 4: LNP023 200 mg b.i.d. for approximately 20 weeks. Four capsules (each 50 mg) were administered each time study medication was taken.
Study NCT03955432 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Reveal LINQ ICM System
Description: The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population.
Study NCT02999165 — intervention group
Intervention type: OTHER
Intervention: Breast feeding
Description: Infants on respiratory support will be allowed to attempt to breast feed (with a top up nasogastric tube feed if required).
Study NCT02403479 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silver Colloid
Description: Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
Study NCT02403479 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Saline
Description: Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.
Study NCT02698527 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Non-Buffered Lidocaine
Description: Active comparator
Study NCT02698527 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buffered Lidocaine
Description: Experimental, additIon of Sodium Bicarbonate to Lidocaine
Study NCT01921322 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pump
Description: 722 Paradigm Real-Time System
Study NCT01921322 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: CGMS Gold
Description: Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
Study NCT00694083 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ridaforolimus
Description: Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles)
Study NCT01375972 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: S-1 plus cisplatin
Description: S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
Study NCT01375972 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine plus Cisplatin
Description: Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
Study NCT01628198 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter
Description: Saline-Irrigated Radiofrequency Ablation Catheter will be placed in the renal arteries in a circumferential manner and energy will be delivered to create 4 burn lesions.~There are 2 devices that can be used---this is optional, based on physician preference:~Celcius Thermacool Catheter Biosense Webster, Inc Diamond Bar, California~or~Chilli II Cooled Ablation Catheter Boston Scientific Corporation San Jose, California
Study NCT04199169 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HeV-sG-V
Description: A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.
Study NCT04199169 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Normal Saline Placebo
Description: 0.9% Saline
Study NCT04199169 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Normal Saline Placebo
Description: 0.9% Saline
Study NCT02989038 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Very Low Nicotine Content Cigarettes
Description: cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
Study NCT02989038 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intermediate Nicotine Content Cigarettes
Description: cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Study NCT02989038 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Normal Nicotine Content Cigarettes
Description: cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Study NCT02731352 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.
Study NCT02731352 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: Apatinib Mesylate Tablets 500 mg q.d. p.o. in 11-20 cases of differentiated thyroid cancer subjects.
Study NCT02406001 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Tigran PTG
Description: Open Flap Debridement
Study NCT02406001 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Surgical intervention
Description: Open Flap Debridement
Study NCT02406001 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgical intervention
Description: Open Flap Debridement
Study NCT01718535 — intervention group
Intervention type: DEVICE
Intervention: Spartan FRX CYP2C19 Test System
Study NCT01721096 — intervention group
Intervention type: DEVICE
Intervention: XIENCE PRIME - Long Length (LL)
Description: Long Length
Study NCT01721096 — intervention group
Intervention type: DEVICE
Intervention: XIENCE PRIME - Core Size
Description: Core Size
Study NCT01882660 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Study NCT01257334 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: BI 10773
Description: patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
Study NCT01257334 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 10773
Description: patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea