TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04531540

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Butenafine HCl 1% (BAY1896425)
Description: Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Study: NCT00971009

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: OPPC service
Description: Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: WebChoice IHCA
Description: The additional features of WebChoice allows patients to monitor their symptoms and health problems from home; provides them with individually tailored, just-in-time information and support to manage their symptoms and illness-related problems between treatments and during rehabilitation; and a forum, or e-group community, for group discussion with other cancer patients.
Study: NCT01225796

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sodium bicarbonate
Description: Sodium bicarbonate 650mg by mouth three times daily for 6 months.
Study: NCT02027038

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic belt application
Study: NCT01351363

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Electrical pain threshold measurement
Description: Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Measurement of electrical pain threshold
Description: Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
Study: NCT02027038

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pelvic belt application
Study: NCT01873508

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RO4917523
Description: Fast release MR capsule, single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RO4917523
Description: Target release MR capsule, single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RO4917523
Description: Slow release MR capsule, single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RO4917523
Description: \[13C\]-labeled tracer dose i.v.
Study: NCT00896844

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: emotional disclosure
Description: writing about emotional events from the past
Study: NCT00629512

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole
Description: 20mg oral daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole
Description: 40mg oral daily

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02462655

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pre-lipid apheresis
Description: Blood samples will be taken just before the start of the lipid apheresis treatment.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Post-lipid apheresis
Description: Blood samples will be taken following the lipid apheresis treatment.
Study: NCT03036605

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bupivacaine
Description: %0.5 bupivacaine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bupivacaine
Description: %0.5 bupivacaine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: 8 mg Dexamethasone
Study: NCT03266523

Intervention type: OTHER
Intervention: Natural images in imaging waiting rooms
Description: Standard environment for hospital imaging waiting rooms

Intervention type: OTHER
Intervention: Natural images in imaging waiting rooms
Description: Standard environment for hospital imaging waiting rooms

Intervention type: OTHER
Intervention: Natural images in imaging waiting rooms
Description: Standard environment for hospital imaging waiting rooms
Study: NCT00814853

Intervention type: DEVICE
Intervention: NAVA (Extubation readiness testing failures)
Description: Patients who fail the ERT will be place in the mode of ventilation NAVA.
Study: NCT02910869

Intervention type: GENETIC
Intervention: Pathway Genomics FIT test

Intervention type: GENETIC
Intervention: Pathway Genomics FIT test
Study: NCT04436211

Intervention type: PROCEDURE
Intervention: Total Knee Arthroplasty
Description: The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)

Intervention type: PROCEDURE
Intervention: Total Knee Arthroplasty
Description: The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
Study: NCT04185519

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AI (model)
Description: The process of the experiment (brief describe) This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. Once the failed rate by AI is higher than the physician is 5%, , the study will be terminated. There will be three periods, namely ry 3 months.
Study: NCT03361592

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Spinal Manipulative Therapy
Description: Lumbar (SMT) was performed using Diversified techniques, aiming to correct vertebral dysfunctional lumbar segments. Participants were asked to lay down prone on, to perform spinal motion palpation analysis was in order to evaluate the presence of dysfunction in vertebral segments of lumbar spine.

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: SHAM
Description: The SHAM (pre-load positioning SMT) was performed with participant body positioning in the lateral position, as the SMT intervention. The doctor followed the participant through the same position of (SMT) intervention, using the maintenance of set-up position, but no manipulative thrust was delivered. The therapist applied minimal pressure and slid their hands across the skin to mimic the manipulative trust. The position was maintained 30 seconds on each side, and none of force or researcher body weight were putted in this procedure, only minimal pressure common to stabilize the set up position of (SMT).
Study: NCT00984282

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib (Nexavar, BAY43-9006)
Description: Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Study: NCT04664777

Intervention type: DEVICE
Intervention: Masimo Model RDS7A
Description: Masimo monitoring platform equipped with Radical-7 Pulse CO-Oximeter fingertip probe for measurement non-invazive hemoglobin level (SpHb) an perfusion index (PI)
Study: NCT02286440

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: AssureRx GeneSight genotyping results

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Treatment as usual
Study: NCT02999282

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Anodal transcranial direct current stimulation
Description: 10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Anodal transcranial direct current stimulation
Description: 10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)
Study: NCT00896844

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: placebo writing
Description: writing about how they spent their time the previous day
Study: NCT03432273

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine lozenge
Description: Nicotine mint lozenge, 2 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine lozenge
Description: NiQuitin mint lozenge, 2 mg
Study: NCT02999282

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham transcranial direct current stimulation
Description: 10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)
Study: NCT02964390

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Balloon Pulmonary Angioplasty
Study: NCT02845791

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Interactive Lifestyle programme workshop
Description: Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
Study: NCT02497079

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Nested PCR for formalin-fixed tissues
Description: For nested PCR, formalin-fixed paraffin-embedded tissues were incubated in 1 mL of xylene at 60°C for 30 min and then centrifuged for 10 min. Paraffin and the supernatant were removed from the samples after centrifugation. The same procedures were repeated until deparaffinization was complete. After adding 1 mL of alcohol, the samples were centrifuged for 5 min, and the supernatant was removed. The sample was then air-dried as a pellet. DNA was extracted using QIAamp (Qiagen, Valencia, CA, USA). PCR amplifications were performed using Mycobacterium tuberculosis IS6110 primers. The first round using outer primers and the second round using inner primers amplified a 256- and 181-bp fragment, respectively. Finally, the PCR products were visualized in a 2% agarose gel.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Nested PCR for fresh tissues
Description: For nested PCR with specimens in sterile saline, DNA was extracted using QIAamp (Qiagen, Valencia, CA, USA). PCR amplifications were performed using Mycobacterium tuberculosis IS6110 primers. The first round using outer primers and the second round using inner primers amplified a 256- and 181-bp fragment, respectively. Finally, the PCR products were visualized in a 2% agarose gel.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Real-time PCR for fresh tissues
Description: For real-time PCR, specimens in sterile saline were filtered and 1 mL of phosphate based saline was added. After centrifugation for 3 min, the supernatant was removed. Next, 50 μL of extraction buffer was added to the sample, and the sample was heated at 100°C for 20 min. After centrifugation for 3 min, the supernatant was used in PCR. Real-time PCR was performed using the AdvanSure TB/NTM real-time PCR kit. Three channels were used in the real-time PCR reaction (Mycobacterium tuberculosis complex, mycobacteria, and internal control). Signals for FAM, HEX, and Cy5 were measured in each channel. Mycobacterium tuberculosis was considered present if the cycle threshold of rpoB was less than 35 on each signal and greater than or equivalent to that of IS6110.
Study: NCT02212106

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Description: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Comparator Quadrivalent Influenza Virus Vaccine
Description: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Study: NCT00999284

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ZK200775
Description: Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
Study: NCT02556736

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RST-001
Description: RST-001 is a gene therapeutic delivered by intravitreal injection
Study: NCT02774746

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 35-week delivery
Description: Induction at 35 weeks gestational age

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 38-week delivery
Description: Observation to spontaneous delivery or induction at 38 weeks gestational age
Study: NCT03594435

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibudilast
Description: targets neurotrophin signaling and neuroimmune function

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral capsule
Description: matched to active drug, ibudilast
Study: NCT02585583

Intervention type: RADIATION
Group type: OTHER
Intervention: Thalamotomy
Description: VoA-Vop complex of the thalamous or VIM nucleus will be targeted. 100 Gy, 120 Gy, 130 Gy, 140 Gy will be the foreseen prescription dose. CyberKnife will be always used to perform the procedure.
Study: NCT04060030

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levoleucovorin Calcium
Description: Liquid leucovorin calcium dosed by weight

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT04118933

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JS001
Description: JS001 240mg, Q3W
Study: NCT02129829

Intervention type: DRUG
Intervention: Tenofovir disoproxil
Description: Tenofovir disoproxil 245 mg once daily
Study: NCT00857415

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: florbetapir F 18
Description: Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: florbetapir F 18
Description: Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Study: NCT06185127

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Dexmedetomidine solution of 1 μg/kg dissolved in 60 ml saline was administered over 15 minutes, followed by a maintenance dose of 0.5 μg/kg/h (continuous infusion).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: A bolus dose of 50 mg ketamine dissolved in 10 ml saline was given 15 minutes after Dexmedetomidine initiation.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam
Description: Bolus doses of midazolam (5 mg midazolam dissolved in 10 ml saline; 2 ml of the solution or 1 mg midazolam per bolus, premedication dose of 2mg, induction dose of 2 mg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 12 mg of midazolam were administered.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fentanyl
Description: Bolus doses of fentanyl (100 μg / 10 ml; 5 ml of the solution or 50 μg fentanyl per bolus, induction dose of 50μg) were administered at 20-minute intervals in between and titrated as needed to obtain the desired sedation depth. No more than 150 μg of fentanyl were administered.
Study: NCT03024697

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Pectoral Plane Block

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Pectoral Plane Block

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Local Anaesthetic Wound Infusion Catheter
Description: Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Local Anaesthetic Wound Infusion Catheter
Description: Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter
Study: NCT03839082

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Usual Care then FitBit
Description: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care then FitBit
Description: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FitBit then Usual Care
Description: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
Study: NCT03861728

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 0.01% Hypochlorous acid
Description: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
Study: NCT03839082

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: FitBit then Usual Care
Description: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
Study: NCT03275792

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D5-0.9%NS
Description: Admission for intravascular volume expansion

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Routine home oral rehydration
Description: Routine oral fluids as is given at home to all children with acute diarrheal disease
Study: NCT01756053

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ABT-089
Description: Selective neuronal nicotinic receptor agonist.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matched placebo capsules supplied by study drug supplier.
Study: NCT03506932

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Untreated
Description: Bread made with 20% yellow pea flour that was untreated.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Heat treated with 0% moisture
Description: Bread made with 20% yellow pea flour that was heat treated with 0% moisture.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Heat treated with 10% moisture
Description: Bread made with 20% yellow pea flour that was heat treated with 10% moisture.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Wheat
Description: Bread made with 100% wheat
Study: NCT01230710

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: Erlotinib was supplied as tablets.
Study: NCT02946983

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Fructose
Description: Intragastric administration of fructose (25g dissolved in 250ml distilled water)
Study: NCT03861728

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo to be used four times a day to the affected eye for 2 weeks
Study: NCT04504773

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Virtual Reality Exposure Therapy
Description: Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
Study: NCT01079598

Intervention type: DEVICE
Group type: OTHER
Intervention: RF Ablation (ClosureRFS Stylet)
Description: Bipolar energy radiofrequency ablation with RFS stylet
Study: NCT01288638

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pulse-based diet
Description: The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: TLC diet
Description: Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses.
Study: NCT00766857

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: exenatide
Description: Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).
Study: NCT04264689

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: serratus anterior block
Description: ultrasound guided block

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: thoracic epidural
Description: thoracic epidural

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: erector spinae block
Description: ultrasound guided block
Study: NCT03063203

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Description: * After 2 cycles, patients with progressive disease or relapse (a clear progression with at least \>20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference~* Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant~* Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference~* Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles~* Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses~* Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone marrow biopsy/aspirate
Description: * Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse~* Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only~* Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Peripheral blood draw
Description: -Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Skin biopsy
Description: * Optional but if refuse skin biopsy then participant can provided buccal swab~* There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine~* If WBC at time of enrollment is \>30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Buccal swab
Description: -Baseline (if skin biopsy declined) and Cycle 2 Day 28
Study: NCT04025710

Intervention type: DEVICE
Group type: OTHER
Intervention: BIOMONITOR III and BIOMONITOR IIIm
Description: * Insertion of BIOMONITOR III or BIOMONITOR IIIm~* three scheduled in-office follow-ups~* 48-hour Holter ECG
Study: NCT02089854

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Toremifene; Anastrozole
Description: Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
Study: NCT02801305

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diltiazem Gel 2%
Description: This a topical agent which will be applied on digital ulcers by scleroderma patients.
Study: NCT00766857

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Insulin glargine
Description: Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.