TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04061590

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

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

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Given IV
Study: NCT03375840

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Immediate posttest

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Immediate posttest

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: delay posttest
Study: NCT04061590

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed Disodium
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Conventional Surgery
Description: Undergo surgery
Study: NCT03375840

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: delay posttest

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: delay posttest
Study: NCT02845375

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sugammadex
Description: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Study: NCT04061590

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Conventional Surgery
Description: Undergo surgery
Study: NCT01422135

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AG200-15
Description: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Study: NCT04786314

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Hot Water Application
Description: Pregnant women will apply hot water to their legs before going to sleep for a week.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cold Water Application
Description: Pregnant women will apply cold water to their legs before going to sleep for a week.
Study: NCT01492686

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MCI-186
Description: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MCI-186 in open label phase
Description: All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: MCI-186 in open label phase
Description: All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Study: NCT04325113

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: levobupivacaine
Description: Patient satisfaction and pain score using a visual anagogic scale (VAS)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: levobupivacaine
Description: Patient satisfaction and pain score using a visual anagogic scale (VAS)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: levobupivacaine
Description: Patient satisfaction and pain score using a visual anagogic scale (VAS)
Study: NCT02118480

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: cognitive remediation program: REHACOP
Description: Specifically, REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Occupational Therapy
Description: The activities included drawing, reading the daily news and constructing using different materials (such as paper or wood). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.
Study: NCT01705535

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Individual supervised pelvic floor muscle exercises
Description: Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Massage of the neck and back
Description: six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard information and guidance
Description: Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standard information and guidance
Description: Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.
Study: NCT00813696

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine
Description: 1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: gemcitabine
Description: 1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: 25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
Study: NCT04215263

Intervention type: OTHER
Intervention: Questionaire
Description: Patient was assessed using mini international neuropsychiatric interview
Study: NCT04484714

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
Study: NCT03434002

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Training by Virtual Reality Simulation
Description: Those Randomized 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Training by Mannequin Based Simulation
Description: Randomized other 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.
Study: NCT03059407

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Dog therapy only
Description: Canine assisted therapy only during echocardiogram

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Dog plus standard distraction tech
Description: Canine assisted therapy plus standard distraction techniques during echo

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Standard distraction techniques only
Description: Standard distraction techniques (such as watching a movie) only during echocardiogram
Study: NCT02167217

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisolone
Description: Prednisolone (5mg per kg) will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
Study: NCT03086018

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Successor hearing aid to Juna
Description: The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.
Study: NCT04550663

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KD-025 CAR-T cells
Description: Autologous genetically modified anti-NKG2DLs CAR transduced T cells
Study: NCT04501289

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low dose magnesium sulphate
Description: Participants in this arm will receive 4g of 20% intravenous (I.V.) MgSO4 (Magphate®) given over 10 minutes, followed by 3g of 50% intramuscular (I.M.) MgSO4 in each buttock statim. Then, maintenance doses will be given as 2.5g of 50% MgSO4 administered intramuscularly 4 hourly for 24 hours, for participants with severe preeclampsia and for 24 hours post delivery or post last seizure episode, whichever occurs last, for cohorts with eclampsia.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pritchard regimen
Description: Participants in this arm will receive loading dose as 4g of 20% MgSO4 I.V. over 10 minutes, followed by 5g of 50% MgSO4 I.M. in each buttock. Maintenance doses will be given as 5g of 50% MgSO4 I.M. 4 hourly in alternate buttock until 24 hours for patients with eclampsia and for 24 hours after delivery or after last fit, whichever occurs later, for cohorts with eclampsia.
Study: NCT03427554

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tretinoin cream 0.1%
Description: Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: RETIN-A® Cream
Description: RETIN-A® (Tretinoin) Cream (Valeant)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle of the test product
Description: Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Study: NCT03697525

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Vibration
Description: Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Vibration
Description: Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).
Study: NCT03894150

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F0002-ADC
Description: Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg
Study: NCT00955786

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CX-3543
Description: Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Study: NCT00730379

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Comparator: ridaforolimus + dalotuzumab
Description: Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).
Study: NCT03350126

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab 200 MG in 40 ML Injection
Description: Induction therapy (12 weeks):~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab 10 MG/ML
Description: Induction therapy (12 weeks) :~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W~Maintenance therapy (40 weeks):~Nivolumab monotherapy IV over 60 minutes Q2W until iRECIST progression or if no PD for one year.
Study: NCT02785874

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Statin
Description: Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival
Study: NCT02459821

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: GE-O SYSTEM
Description: The first group will be subjected to RAGT for 9 weeks (2 sessions/ week) with a total of 18 sessions by mean of GE-O System (9). During each session, the patients will practice 15 to 20 min of simulated floor walking followed by 5 to 10 min of repetitive simulated stair climbing up and down. Breaks will be optional, but uninterrupted training intervals of at least 5 min for simulated floor walking and 3 min of simulated stair climbing will be required. When the patient reaches the maximum amount of time, speed of gait will then be progressively increased. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional training
Description: The conventional walking group will be subjected to a conventional gait training for 9 weeks (2 sessions/week) with a total of 18 sessions. Each session will last altogether 50 minutes, the first 30 minutes will be dedicated to gait and stair climbing up and down training while the last 20 minutes to stretch the lower limb's muscles.
Study: NCT03673462

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
Description: Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)
Description: Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Description: Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Description: Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumococcal 13-valent Conjugate Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Pneumococcal 13-valent Conjugate Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rotavirus Vaccine
Description: Pharmaceutical form: Oral solution Route of administration: Oral

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Rotavirus Vaccine
Description: Pharmaceutical form: Oral solution Route of administration: Oral

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Hepatitis B Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Hepatitis B Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Measles, Mumps, and Rubella Virus Vaccine
Description: Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Measles, Mumps, and Rubella Virus Vaccine
Description: Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Varicella Virus Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Varicella Virus Vaccine
Description: Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
Study: NCT04006561

Intervention type: RADIATION
Intervention: A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy
Description: Each freshly-diagnosed patient with primary CNS lymphoma will be treated with combined chemoradiation in a sandwiched way, in which 2 cycles of induction chemotherapy with intravenous methotrexate (MTX in a conventional dose of 1g/m2) and intrathecal MTX are followed by a complete course of hyperfractionated WBRT and then high-dose cytarabine for 2 cycles.
Study: NCT03303469

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FMISO
Description: FMISO PET/CT imaging at baseline

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FMISO
Description: FMISO PET/CT post TACE

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FMISO
Description: FMISO PET/CT post SBRT
Study: NCT01119430

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: DU125530
Description: 20mg/twice a day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Similar pill as active comparator twice a day
Study: NCT01112228

Intervention type: PROCEDURE
Intervention: Bariatric surgery
Description: Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
Study: NCT02415348

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Fibroscan
Study: NCT01433523

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: ALK HDM AIT Placebo
Description: Oral lyophilisate, Placebo, to be administered sublingually once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ALK HDM AIT 6 DU
Description: Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ALK HDM AIT 12 DU
Description: Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
Study: NCT01785563

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Nasal NIV-NAVA
Description: Infants will be placed on nasal NIV-NAVA. Patients initial NAVA level will be set to generate a peak inspiratory pressure that is 8 cm of water greater than their current peak end expiratory pressure. If the infants are on nasal NIV-NAVA at the time of study entry their NAVA level will be increased by 50% rounded up to the nearest 0.1 cm of water per microvolt.
Study: NCT02913976

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Kinesio Taping
Description: Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Sham Kinesio Taping
Description: Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
Study: NCT04048863

Intervention type: DEVICE
Group type: OTHER
Intervention: B. Braun Peripheral Advantage (PA) Program
Description: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Intervention type: DEVICE
Group type: OTHER
Intervention: B. Braun Peripheral Advantage (PA) Program
Description: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Intervention type: DEVICE
Group type: OTHER
Intervention: B. Braun Peripheral Advantage (PA) Program
Description: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hospital Standard of Care
Description: Standard of Care for PIVC access per hospital protocol
Study: NCT02558270

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dapagliflozin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dapagliflozin

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo