AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04279600 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Taurine
Description: Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
Study NCT04279600 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Taurine
Description: Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
Study NCT04279600 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day
Study NCT04279600 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Exercise training
Description: 4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
Study NCT04279600 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise training
Description: 4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
Study NCT01738178 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Caffeine
Study NCT01738178 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT01765998 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Probiotic
Description: Clinical evaluation according to the Crohn's activity scale
Study NCT01765998 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT01540539 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: REGN1154 or placebo
Description: Participants will receive active drug or placebo
Study NCT03684330 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: whole body vibration (WBV)
Description: 03 months of WBV training three times per week
Study NCT02197741 — intervention group
Intervention type: DRUG
Intervention: opiate with bolus
Study NCT01960296 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clopidogrel
Description: Continue home dose of clopidogrel into surgery
Study NCT01960296 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Discontinue Clopidogrel
Description: Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Study NCT03653299 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Placebo or Active Phototherapy (MR4)
Description: Phototherapy, placebo or active, will applied in 9 different points of anterior muscle of the thigh, 6 different points of posterior muscle of the thigh and 2 different points of the gastrocnemius muscle, bilaterally. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.
Study NCT00838188 — intervention group
Intervention type: OTHER
Intervention: Way of Feeding - Breast feeding vs. Bottle feeding
Description: Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Study NCT03100292 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sleeve gastrectomy or Roux-en-Y gastric bypass
Study NCT01152138 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Open cells stent
Description: Cobalt Chromium Stent with open cell design
Study NCT01152138 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Closed Cells Stent
Description: Cobalt Chromium stent with closed cell design
Study NCT00950027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: povidone iodine
Description: oropharyngeal decontamination every 4 hours
Study NCT00950027 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: oropharyngeal decontamination every 4 hours
Study NCT02328716 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cytoreduction
Description: Cytoreduction
Study NCT02328716 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cytoreduction
Description: Cytoreduction
Study NCT02328716 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hipec with Cisplatin
Description: Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
Study NCT00575796 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vinblastine Sulphate
Description: Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.
Study NCT00058799 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose Level 1
Description: Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 2 x 10\^5
Study NCT00058799 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose Level 2
Description: Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 2 x 10\^5
Study NCT00058799 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Dose Level 3
Description: Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 4.2 x 10\^7
Study NCT00947154 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aripiprazole
Description: aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
Study NCT05306678 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Prolonged sitting
Description: After consuming breakfast, participants sat on a chair for 180 min. After 180 min, lunch was provided. After finishing lunch, participants sat on a chair for another 120 min.
Study NCT05306678 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Breaking sitting
Description: After consuming breakfast, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, lunch was provided. After finishing lunch, participants continued 2 min of walking every 20 min for the following 120 min.
Study NCT02171715 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBW 2992 MA2
Description: film-coated immediate release tablet - final formulation
Study NCT03432663 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravenous amiodarone(1)
Description: Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
Study NCT03432663 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravenous amiodarone(2)
Description: Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached
Study NCT01468623 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
Description: OnDose is a commercially available assay to measure concentration of 5-FU exposure.
Study NCT00161421 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Testosterone
Description: 200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food
Study NCT00161421 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprolide (Lupron)
Description: 7.5 mg injection into muscle (once) (Day -14)
Study NCT01468623 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of care
Description: Patients' dose of 5-FU will be based on Body Surface Area (BSA).
Study NCT02873832 — intervention group
Intervention type: BIOLOGICAL
Intervention: Blood sample
Study NCT02873832 — intervention group
Intervention type: OTHER
Intervention: Flow cytometry
Study NCT02873832 — intervention group
Intervention type: OTHER
Intervention: western blot
Study NCT02189811 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: IPV
Description: IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age
Study NCT02744547 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Spirulina
Description: Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Study NCT02189811 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bOPV
Description: bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age
Study NCT02189811 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bOPV and IPV
Description: bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
Study NCT02189811 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bOPV and IPV and IPV2
Description: bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
Study NCT02189811 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: tOPV
Description: tOPV till 22 weeks of age
Study NCT01951027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GX-G3 12.5 μg/kg or Placebo
Description: Single SC injection
Study NCT01951027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GX-G3 25 μg/kg or Placebo
Description: Single SC injection
Study NCT01951027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GX-G3 50 μg/kg or Placebo
Description: Single SC injection
Study NCT01951027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GX-G3 100 μg/kg or Placebo
Description: Single SC injection
Study NCT00968968 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lapatinib
Description: Oral Lapatinib 1000 mg once daily. Lapatinib was a small molecule, reversible inhibitor targeting HER2 tyrosine kinase receptor.
Study NCT00968968 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Trastuzumab
Description: IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab was a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.
Study NCT00968968 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Trastuzumab
Description: IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab was a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.
Study NCT03116269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilostazol 100mg
Study NCT03116269 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Study NCT03446768 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Peer support
Description: Access to educational and informational support by a trained peer coach
Study NCT00870155 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dirucotide
Description: 500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
Study NCT01691313 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vanoxerine
Description: single oral dose
Study NCT02171715 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBW 2992 MA2
Description: film-coated immediate release tablet - trial formulation II
Study NCT03446768 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Online platform
Description: An online platform that provides educational, informational and access to several therapeutic device metrics
Study NCT03446768 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Respiratory Therapist support
Description: Limited medical support provided by trained Respiratory Therapists.
Study NCT02171715 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BIBW 2992 MA2
Description: powder for oral solution
Study NCT03530163 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Respiratory Muscle Training
Description: Subjects will breathe through a custom isocapnic Respiratory Muscle Training method developed in-house. The initial breathing frequency will be 30 breaths per minute. Subsequent sessions will begin with 20 minutes of breathing at the highest rate attained on the previous training day. During the last 10 minutes of each session, breathing rate will increase by 1-2 breaths/min.
Study NCT03530163 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Breathing Training
Description: Each subject in the sham group will be prompted to hold his breath for 10 seconds every 30 seconds (two times each minute) while breathing on a circuit visibly identical to that used in Respiratory Muscle Training. The subject will breathe ambient air normally after each breath hold. Each sham session will last 30 minutes total.
Study NCT01691313 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: single oral dose
Study NCT04845971 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Saisei Maf capsules
Description: Dietary supplement name: Colostrum MAF, Saisei MAF immunomodulator. Formulation: 148 mg acid-resistant coated capsules, containing 2.3 mg of enzymatically treated bovine colostrum powder and supplementary ingredients The dietary supplement substances: Active ingredien: Enzymatically treated bovine colostrum powder 2.3 mg 1.6 % Supplementary ingredients: Lactase (Derived from yeast) 0,15 mg 0.1 % HPMC (Hydroxypropyl Methylcellulose) acid-resistant capsule 47 mg 31.8 % Microcrystalline cellulose (Derived from pulp) 98,4 mg 66.5 % Dosage for adults: 2 - 10 capsules daily (stronger version 9 capsules daily) Route of administration: oral Contraindication: allergy to dairy product components Precaution: pregnancy and lactation Storage: Can be stored in at + 5 to +25°C, on dry place for up to two years Manufacturer: Saisei Pharma, Osaka, MORIGUCHI city, OKUBO-cho, 3-34-8. Japan
Study NCT03325881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHP465
Description: SHP465 capsule 6.25 mg orally once daily for 4 weeks
Study NCT03325881 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo matching to SHP465 capsule orally once daily for 4 weeks
Study NCT05740098 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Best Practices
Description: Five As plus referral to a quit line
Study NCT05740098 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Financial Incentives
Description: Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Study NCT05740098 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine Replacement Therapy
Description: Nicotine patches and gum/lozenge provided together for dual therapy
Study NCT02243579 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study NCT02243579 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Given IV
Study NCT04101396 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: diabetic diet
Description: Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Study NCT00570635 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: XL820
Description: XL820 capsules administered orally as a single agent at a dose of 800 mg daily
Study NCT00570635 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: XL820
Description: XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
Study NCT00489177 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: A
Description: QuickOpt intra-cardiac electrogram optimization
Study NCT00489177 — intervention group
Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: B
Description: Single optimization in initial month post-implant
Study NCT03887884 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CVT-301
Description: Levodopa Inhalation Powder
Study NCT03887884 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sinemet
Description: Single oral dose of Carbidopa/Levodopa 25 mg/100 mg
Study NCT01090206 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Vitamin D and calcium
Description: Doses will be based on Vitamin D levels
Study NCT00408447 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Busulfan
Description: Busulfan 4 mg/kg/d x 4d
Study NCT00408447 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Fludarabine
Description: Fludarabine 30 mg/m2/d x 6d
Study NCT00408447 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Alemtuzumab
Description: Alemtuzumab 2mg/m2 x 1d, 6mg/m2 x 2 d, 20mg/m2 x 2d
Study NCT00834717 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Granisetron hydrochloride 1 mg tablets
Description: 2 x 1 mg, single dose fasting
Study NCT00408447 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Allogeneic stem cell transplant
Description: Allogeneic stem cells will be given on day 0 (after chemotherapy conditioning)obtained either from a family donor (first degree relative) or sibling cord blood donor.
Study NCT00127933 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine [Xeloda]
Description: 825mg/m2 po bid on days 1-14 of each 3 week cycle
Study NCT00127933 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Taxotere
Description: 75mg/m2 iv on day 1 of each 3 week cycle
Study NCT00127933 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Herceptin (HER2-neu positive patients only)
Description: 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly
Study NCT03093168 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Anti-BCMA CAR-T cells
Description: Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Study NCT03093168 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: dose: 25mg/m2/d
Study NCT00834717 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Kytril® 1 mg tablets
Description: 2 x 1 mg, single dose fasting
Study NCT04492540 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: aerobic exercise and MIND diet program
Description: the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks
Study NCT03093168 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Dose: 40mg/kg
Study NCT04299620 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Digital Image Analysis
Description: Analysis of images
Study NCT04299620 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical Prostatectomy
Description: Undergo standard of care radical prostatectomy
Study NCT04492540 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: MIND diet program
Description: control group will receive diet program for 12 weeks
Study NCT04299620 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transrectal Ultrasound
Description: Undergo transrectal ultrasound
Study NCT04833608 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Vktory insoles
Description: Patients were randomized into either the Carbon fiber insole group or Morton's extension group.
Study NCT04833608 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Morton's extension insoles
Description: Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group.
Study NCT00498485 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.
Study NCT00498485 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Oxybate
Description: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.