AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Medium-dose V180 with Alhydrogel™ adjuvant
Description: Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose V180 (non-adjuvanted)
Description: Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose V180 with low-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose V180 with high-dose ISCOMATRIX™ adjuvant
Description: Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Study NCT01477580 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Study NCT00160342 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Esterified Estrogens (EE) and Methyltestosterone (MT)
Description: oral tablet, QD, 12 weeks, Placebo
Study NCT04521842 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Total hip replacement
Description: Total hip replacement in treatment of end-stage osteoarthritis
Study NCT04521842 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Total hip replacement
Description: Total hip replacement in treatment of end-stage osteoarthritis
Study NCT02331784 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Computerized Plasticity-based Software
Description: Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
Study NCT02331784 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Commercially available Video Game
Description: Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
Study NCT00963846 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: matching pill placebo
Study NCT00963846 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: huperzine 0.2 mg BID
Description: huperzine rising doses up to 0.2 mg BID
Study NCT00963846 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: huperzine 0.4 mg BID
Description: huperzine rising doses up to 0.4 mg BID
Study NCT00963846 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: huperzine 0.8 mg BID
Description: huperzine rising doses up to 0.8 mg BID
Study NCT00797940 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IL-4PE
Description: Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
Study NCT03260114 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Personal Activity Intelligence
Description: Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI. A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI. Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.
Study NCT02151214 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Parenteral nutrition
Description: Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
Study NCT04409977 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: MRI examination
Description: Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.
Study NCT00642603 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine [Xeloda]
Description: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
Study NCT00642603 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab [Avastin]
Description: 5 mg/kg taken intravenously on Day 1 of each 2 week cycle
Study NCT00642603 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxaliplatin
Description: 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Study NCT00642603 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan
Description: 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Study NCT01986296 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ExAblate Transcranial MRgFUS System
Description: Treatment with the ExAblate Transcranial MRgFUS System.
Study NCT01122459 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: fluid administration
Description: 1.5mls/kg/hr fasting
Study NCT01268189 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Oxygen diffusing dressing
Description: Oxygen diffusing dressing applied to study wound
Study NCT01268189 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Standard of care dressing
Description: Xeroform control dressing applied to control wound
Study NCT05933785 — intervention group
Intervention type: PROCEDURE
Intervention: transanal endoscopic ISR
Description: perform ISR using laparoscopy through transanal port
Study NCT01893047 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: live music
Description: live harp music
Study NCT01893047 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: recorded music
Description: recorded harp music
Study NCT02395419 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Orotracheal intubation with Totaltrack
Study NCT02395419 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Orotracheal intubation with Airtraq
Study NCT00167232 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naltrexone
Study NCT00167232 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Naltrexone
Study NCT01928238 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).
Study NCT01928238 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Noninvasive pressure support ventilation (NPSV)
Study NCT03340467 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CGM patch
Description: Patient receives four CGM patches.
Study NCT03298308 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cranial Electric Stimulation
Description: Micro amperage TCDS
Study NCT02815150 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: preoperative oral carbohydrate drink
Description: 5% glucose solution 250ml 2-3 hours before surgery
Study NCT01646385 — intervention group
Intervention type: DRUG
Intervention: etanercept
Description: use as per routine clinical practice
Study NCT01646385 — intervention group
Intervention type: DRUG
Intervention: non-biologic anti-rheumatic drugs
Description: use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)
Study NCT04471545 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Pectoral nerve block type II
Description: A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided
Study NCT04471545 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pectoral nerve block type II
Description: A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided
Study NCT01651169 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: methylphenidate tablets and Inter-stimulus Intervals (ISI)
Description: We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.~Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity
Study NCT01651169 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: methylphenidate tablets and Inter-stimulus Intervals (ISI)
Description: We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.~Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity.
Study NCT01749852 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Polyphenol-rich Dark chocolate
Description: Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
Study NCT01749852 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Dark chocolate
Description: Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
Study NCT02846064 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Autograft of cryopreserved ovarian tissue
Description: Orthotopic transplantation
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min
Description: Abylcap settings
Study NCT01913977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min
Description: Abylcap settings
Study NCT01984567 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin E
Description: Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg
Study NCT01984567 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Lipoic acid
Description: Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg
Study NCT02330172 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Injection of neostigmine or sugammadex
Description: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
Study NCT01984567 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Control
Description: Daily consumption of 3 placebo capsules
Study NCT01146977 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: HDAC chemotherapy
Description: If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
Study NCT01146977 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Autologous HCT
Description: After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.~If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.
Study NCT02322086 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topical Rose Bengal, 0.005%
Description: Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites).
Study NCT00692549 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ultrasound
Study NCT00511186 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.
Study NCT00511186 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIAP
Description: AP is administered intravenously over 48 hours. An initial loading dose of 67.5U/Kg body weight over 10-minutes is followed by continuous infusion of 132.5U/Kg/24H administered over 48H
Study NCT01809899 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Enhanced consent procedure
Description: Enhanced consent entails a more detailed consent procedure
Study NCT01809899 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Consent as Usual
Description: Routine informed consent procedures
Study NCT03201900 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E2007
Description: Oral tablet
Study NCT02790775 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-VEGF in quadrant 1
Study NCT02790775 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-VEGF in quadrant 2
Study NCT02790775 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-VEGF in quadrant 3
Study NCT02790775 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anti-VEGF in quadrant 4
Study NCT00133055 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self-help treatment booklet and telephone support
Description: The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.
Study NCT00133055 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Usual care by a family physician
Description: Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
Study NCT02875002 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: volasertib
Description: Volasertib (BI6727) is a small molecule inhibitor of the polo-like kinase 1 (PLK1) protein. Infusion for 60 minutes. Dosing will start at 25 mg/m\^2, is schedule to increase to 100mg/m\^2, and be administered on days 1 and 8 of each 28-day cycle.
Study NCT02875002 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: belinostat
Description: Belinostat is a histone deacetylase inhibitor. Infusion will take 30 minutes. Dosing will start at 600 mg/m\^2 , is scheduled to increase to 1000 mg/m\^2, and will be administered on days 1,2,3 and 8,9,10 of each 28-day cycle.
Study NCT02927015 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Purple Majesty potato chips
Description: Purple Majesty potato chips
Study NCT02927015 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Mountain Rose potato chips
Description: Mountain Rose potato chips
Study NCT00943501 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
Study NCT00943501 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
Study NCT00943501 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liraglutide
Description: Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Study NCT00943501 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Study NCT02171832 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1744 CL, low dose
Study NCT02171832 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1744 CL, high dose
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Percutaneous angioplasty
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Balloon angioplasty
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Right heart catheterization
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Echocardiography
Study NCT02844036 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: A six-minute walking test
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Functional respiratory investigations
Study NCT02844036 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pulmonary tomography or pulmonary angiography
Study NCT02844036 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Biological parameters
Study NCT01520519 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.
Study NCT01520519 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PCI-32765
Description: 420 mg (3 \* 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily.
Study NCT03992677 — intervention group
Intervention type: OTHER
Intervention: No intervention
Description: No intervention
Study NCT01447641 — intervention group
Intervention type: OTHER
Intervention: Polysomnography
Description: Overnight physiological recording of sleep
Study NCT01447641 — intervention group
Intervention type: OTHER
Intervention: Actigraphy
Description: Wristwatch activity to measure basic rest activity cycle and sleep efficiency
Study NCT00719394 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSI 136
Study NCT00719394 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo