AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03900481 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Vertical gastric plication
Description: Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive.
Study NCT03931707 — intervention group
Intervention type: GENETIC
Intervention: Genomic sequencing
Description: Both sick and high-risk newborn un-randomized to receive genomic sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
Study NCT02531958 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Eggs
Description: Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.
Study NCT00142961 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atomoxetine
Description: atomoxetine
Study NCT00142961 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study NCT06354127 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DWP450
Description: The test drug or control drug is injected on the day of administration.
Study NCT06354127 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Botox®
Description: The test drug or control drug is injected on the day of administration.
Study NCT01018420 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Colchicine
Description: two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses
Study NCT01018420 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Moxifloxacin
Description: 400 mg capsule at the 6 hour point
Study NCT00964808 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine
Description: Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
Study NCT01564810 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of cetuximab (initial dose 400 mg/m2 in week 1, and 250 mg/m2 weekly during 1 hour thereafter) followed after 1 hour by chemotherapy of FOLFOX or FOLFIRI until progressive disease or unacceptable toxicity.
Study NCT01564810 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: chemotherapy of mFOLFOX6 or FOLFIRI
Description: FOLFOX-4 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV200mg/m2ondays 1and 2 infused during 2 hours, together with or following oxaliplatin; followed by FU 400 mg/m2 intravenous bolus then 600 mg/m2 intravenous infusion over 22 hours on days 1 and 2) FOLFIRI(irinotecan 180mg/m2 on day 1 infused during 2 hours; fluorouracil in a bolus of 400 mg/m2 and then continuous infusion for 46 hours of 2400 mg/m2)
Study NCT01564810 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: chemotherapy of mFOLFOX6 or FOLFIRI
Description: FOLFOX-4 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV200mg/m2ondays 1and 2 infused during 2 hours, together with or following oxaliplatin; followed by FU 400 mg/m2 intravenous bolus then 600 mg/m2 intravenous infusion over 22 hours on days 1 and 2) FOLFIRI(irinotecan 180mg/m2 on day 1 infused during 2 hours; fluorouracil in a bolus of 400 mg/m2 and then continuous infusion for 46 hours of 2400 mg/m2)
Study NCT01605539 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cannabidiol 400
Description: Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions
Study NCT04549948 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 0.017X0.025 Stainless steel
Description: Leveling curve of Sppe using 0.017X0.025 SS archwire
Study NCT04549948 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 0.019X0.025 Stainless steel
Description: Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire
Study NCT01605539 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cannabidiol 800
Description: Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions
Study NCT01605539 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Control
Description: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study
Study NCT00539006 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FPNS
Description: fluticasone propionate nasal spray
Study NCT00539006 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FFNS
Description: fluticasone furoate nasal spray
Study NCT00539006 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo FPNS
Description: placebo nasal spray matching fluticasone propionate nasal spray
Study NCT00539006 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo FFNS
Description: placebo nasal spray matching fluticasone furoate nasal spray
Study NCT03879759 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NAC 2400mg/day
Description: 2400mg/day 2 x 600mg b.d
Study NCT03879759 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 4 matched placebo tablets/day
Study NCT00104962 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lenalidomide
Description: Given orally
Study NCT00124709 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pimecrolimus
Description: Pimecrolimus cream 1 %
Study NCT00124709 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Corticosteroid
Description: conventional corticosteroid-based treatment
Study NCT06412380 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Implant insertion
Description: All patients received a single Tapered Screw implant (Bioinnovation Dental®, Brazil). The implants were placed according to the manufacturer's instructions by using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon. These implants were multi-threaded, and their surfaces were both sandblasted and acid etched. Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.
Study NCT00989365 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Aerobic training
Description: Treadmill training
Study NCT00595946 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lubiprostone
Description: 24 mcg capsules twice daily (BID)
Study NCT00595946 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 0 mcg capsules twice daily (BID)
Study NCT03062878 — intervention group
Intervention type: OTHER
Intervention: Arterial blood pressure
Description: Continuously monitored for 5-30 minutes via finger photoplesmography
Study NCT03062878 — intervention group
Intervention type: OTHER
Intervention: Vascular Ultrasound
Description: Assessment of carotid artery cross sectional area and intima-media thickness. Assessment of brachial artery diameter
Study NCT03062878 — intervention group
Intervention type: OTHER
Intervention: Venous blood sample
Description: Evaluation of oxidative stress via serum lipid hydroperoxide
Study NCT03062878 — intervention group
Intervention type: OTHER
Intervention: Skin microcirculatory blood flow
Description: Assessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine (ACh) and sodium nitroprusside (SNP) via iontophoresis.
Study NCT01199510 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care
Description: Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
Study NCT00964808 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxycodone
Description: Start: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg \* 2 pr. day until time to discharge from the Hospital or latest at day 12.
Study NCT01199510 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Post Cataract Surgery Standard of Care
Study NCT00938392 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GSK investigational FluNG vaccine GSK2186877A, aged lot
Description: Single dose, intramuscular injection
Study NCT00938392 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GSK investigational FluNG vaccine GSK2186877A, fresh lot
Description: Single dose, intramuscular injection
Study NCT00848666 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topical therapy
Description: One time immersion of the feet in a liquid containing water, alcohol, vinegar, benzoic acid and salicylic acid for a total of 30 minutes.
Study NCT02487459 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BPX-501
Description: T cells transduced with CaspaCIDe suicide gene
Study NCT01297673 — intervention group
Intervention type: PROCEDURE
Intervention: video-urodynamic examination
Description: Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics
Study NCT02487459 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AP1903
Description: dimerizer drug administered to treat GVHD
Study NCT04391686 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: indirect calorimetry
Description: to determine and compare the resting energy expenditure of each group
Study NCT00690846 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: adalimumab
Description: 40 mg weekly adalimumab injection.
Study NCT03105076 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Decision aids
Description: Shared decision making with decision aids
Study NCT00265616 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: propofol
Description: liquid, mg/kg.h, titrated after EEG
Study NCT00265616 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: thiopental/pentobarbital
Description: liquid, mg/kg.h, titrated after EEG
Study NCT03684447 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propofol
Description: Series of 6 treatments with propofol.
Study NCT03684447 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propofol
Description: Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.
Study NCT05122949 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 3D Printed Ankle-Foot Orthosis
Description: 3D Printed (Fused Deposition Modelling) Ankle-Foot Orthosis with Polyamide Nylon-12 material
Study NCT05122949 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Thermoformed Ankle-Foot Orthosis
Description: Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene
Study NCT02691767 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pazopanib
Study NCT01283048 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BKM-120 Bevacizumab
Description: BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Study NCT02529410 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cardiac Resynchronisation Therapy
Study NCT02529410 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cardiac Resynchronisation Therapy
Study NCT00774098 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dextrose 10% (D10W ®) infusion
Description: Started at 8pm the day before surgery until the procedure begins
Study NCT00774098 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: hyperinsulinemic normoglycemic clamp
Description: Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively
Study NCT00774098 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: high calorie diet 35 kcal/kg
Description: High Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery
Study NCT00774098 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Intravenous normal saline (NS 0.9)
Description: Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output
Study NCT01177033 — intervention group
Intervention type: OTHER
Intervention: Best endovascular treatment or Best surgical treatment
Description: Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
Study NCT00613600 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Glucomannan
Description: Two 665 mg capsules of glucomannan three times a day for 8 weeks
Study NCT00613600 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Inert microcrystalline cellulose
Description: Two capsules of inert microcrystalline cellulose three times a day for eight weeks
Study NCT02175069 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Interscalene Nerve Block
Description: ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
Study NCT02175069 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Interscalene Nerve Block
Description: ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
Study NCT02175069 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ropivacaine 0.75%, 20ml
Description: 20 ml of ropivacaine 0.75%
Study NCT03209973 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tislelizumab
Description: Administered as specified in the treatment arm
Study NCT02823587 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pulmonary Rehabilitation
Description: The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.
Study NCT02823587 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Control
Description: No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits
Study NCT04520087 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: allograft fixation
Description: Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.
Study NCT01293682 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcitriol
Description: In pill form, 45 micrograms once a week for 12 weeks
Study NCT03700515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythropoietin
Description: Subjects receive weekly infusions of EPO
Study NCT03700515 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects receive weekly infusions of saline
Study NCT03488537 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: AeonoseTM
Description: Breath test
Study NCT03258515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD6094 200 mg
Description: A potent and selective small molecule mesenchymal epithelial transition (MET) kinase inhibitor with significant antitumor activity.
Study NCT03258515 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: AZD6094 matching placebo without any pharmacological activity.
Study NCT02175069 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gadopentetate-Dimeglumine 0.0125 mmol
Description: 0.0125 mmol of gadopentetate-dimeglumine
Study NCT02175069 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gadopentetate-Dimeglumine 0.05 mmol
Description: 0.05 mmol of gadopentetate-dimeglumine
Study NCT02175069 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ropivacaine 0.75%, 5ml
Description: 5 ml of ropivacaine 0.75%
Study NCT02175069 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Shoulder Surgery
Description: As per individual requirement (patient-dependent)
Study NCT02175069 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Shoulder Surgery
Description: As per individual requirement (patient-dependent)
Study NCT00754247 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.5% hydrocortisone, silicone, vitamin E lotion
Description: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing.
Study NCT00754247 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Onion extract gel
Description: Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
Study NCT00754247 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Cetearyl alcohol lotion
Description: Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion.
Study NCT01743092 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Webinar
Description: Some clients will receive a webinar as part of their treatment.
Study NCT01743092 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Tutuorial workbook
Description: A work book about their addiciton
Study NCT01743092 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Tutuorial workbook
Description: A work book about their addiciton
Study NCT02421458 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: 6 x 6 Gy
Description: radiation in 6 fraction of 6 Gy, twice a week during 3 weeks
Study NCT02421458 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: 16 x 3.125 Gy
Description: radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks
Study NCT06574230 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: TRAINING PROGRAM
Description: Each training session included a structured set of exercises aimed at enhancing these skills. For example, participants practiced precision drills to target specific areas of the dartboard, endurance drills to build stamina for longer games, and competitive exercises to simulate real-game conditions. This combination of theoretical knowledge, practical skill development, and strategic gameplay was designed to comprehensively improve the participants\&#39; dart-throwing abilities over the course of the program. A 12-week dart training program, with sessions conducted three times per week, each lasting 90 minutes. In the first week, participants received comprehensive theoretical and practical instruction covering the rules of the game, proper breathing techniques, and throwing mechanics. This initial phase was designed to ensure a solid understanding of the fundamentals before progressing to more advanced training.
Study NCT06410872 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: BART Task
Description: The Zuckerman's Sensation Seeking Scale version-V (SSS-V) - Four-factor score, The Barret Impulsiveness Scale (BIS), Gormally's Binge Eating Scale (BES), The World Health Organization-developed AUDIT (Alcohol Use Disorders Identification Test) screen, The CAGE questionnaire for substance abuse-adapted to include drugs, Gamblers Anonymous's 20 Questions (GA20), Hospital Anxiety and Depression Scale (HADS)
Study NCT00134381 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Green Tea
Description: Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
Study NCT00134381 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
Study NCT03258515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Moxifloxacin
Description: A fluoroquinolone broad-spectrum antibiotic, produces a mild, but reproducible increase in QT interval corrected (QTc) in healthy normal participants at time to reach maximum concentration (tmax - approximately 2 hours (0.5 to 4 hours)). This effect is close to the ECG interval measured from the onset of the QRS complex (onset of the QRS complex to the J point) to the offset of the T wave (QT)/QTc effect that represents the threshold of regulatory concern, around 5 ms mean QTc interval prolongation.
Study NCT05548608 — intervention group
Intervention type: OTHER
Intervention: Reposition error (RE), pain at target positions of RE and flexibility of the TLF were assesed with iphone tiltmeter app, VAS and goniometric platform, respectively.
Description: Target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.
Study NCT01158222 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sunitinib malate
Description: Given orally
Study NCT00632697 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: pentoxifylline
Description: 800 mg daily for six months
Study NCT00632697 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo