TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02655783

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 5% dextrose
Description: women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: normal saline
Description: women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: normal saline
Description: women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution
Study: NCT01302600

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olesoxime
Description: Liquid suspension formulation, 100 mg/ml at a dose of 10 mg/kg will be administered once a day with food at dinner
Study: NCT04129268

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cycle ergometry exercise at 60% VO2max
Description: Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cycle ergometry exercise at 60% VO2max
Description: Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cycle ergometry exercise at 60% VO2max
Description: Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).

Intervention type: OTHER
Group type: OTHER
Intervention: Cycle ergometry exercise at 60% VO2max
Description: Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).
Study: NCT05367648

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo comparator
Study: NCT01595971

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Continuing education
Description: Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: usual care
Description: Received the usual care provided
Study: NCT04610268

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: transcranial direct current stimulation
Description: Depending on the location of sEEG electrode implanted in the patient's head, the tDCS electrode (5 cm×7 cm each) was placed on occipital-frontal lobe or bilateral temporal lobe. Current intensity: 2 mA and 4 mA, Stimulus time: 3 min (each stimulus session).
Study: NCT01874132

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise training
Description: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise training
Description: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
Study: NCT00712127

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Diet and Exercise
Description: The participants in this intervention will receive 12 months of weight loss through diet and exercise

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Diet and Exercise-Delayed
Description: Participants in this intervention will receive six months of weight loss through diet followed by six months of diet and exercise
Study: NCT03021122

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PedAMINES™ / Conventional Method
Description: Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:~• PedAMINES™ (Period 1) and then Conventional Method (Period 2)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional Method / PedAMINES™
Description: Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:~• Conventional Method (Period 1) and then PedAMINES™ (Period 2)
Study: NCT02897037

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bivalirudin
Description: Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: heparin
Description: heparin monotherapy
Study: NCT01519544

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Temazepam
Description: Temazepam 7.5mg capsule to be taken by mouth at bedtime for one night only.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acetazolamide
Description: Take Acetazolamide 125mg tablet by mouth at bedtime for one night only.
Study: NCT03973554

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pearl powder
Description: natural product, support bone and joint health

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CPP-ACP
Description: Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
Study: NCT01253148

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TheraSphere® Yttrium-90 (Y-90) Microspheres
Description: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
Study: NCT02696057

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: manual technics
Description: soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: spinal stabilization exercise applied three sessions per week, totally six week.
Study: NCT03136497

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 400mg ABT-199
Description: Oral dose daily until disease progression

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibrutinib
Description: Oral dose daily until disease progression

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibrutinib
Description: Oral dose daily until disease progression

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab will be administered IV per institutional standards. weekly X 4 (Cycle 1); once on Day 1 of cycles 2-6 only, then every other cycle until Cycle 24 (total 18 doses of Rituxan from C1D1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab will be administered IV per institutional standards. weekly X 4 (Cycle 1); once on Day 1 of cycles 2-6 only, then every other cycle until Cycle 24 (total 18 doses of Rituxan from C1D1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 800mg ABT-199
Description: Oral dose daily until disease progression
Study: NCT00735826

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vorinostat
Description: Vorinostat will be administered orally once daily in an open-labeled, unblinded manner to all subjects enrolled in the study. Subjects will receive vorinostat 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection. Vorinostat should be taken with food within 0 to 30 minutes of a meal if possible. Patients should take the medication at approximately the same time each day on an ongoing basis. Missed doses will not be made up.
Study: NCT04597216

Intervention type: DEVICE
Group type: OTHER
Intervention: sample of blood and saliva
Description: sample of 3ml of blood by veinous puncture, of 1 drop of blood by needlestick, and of saliva by spitting
Study: NCT02970630

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: once a day

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Everolimus
Description: twice daily
Study: NCT03069248

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpha Interferon
Study: NCT03273647

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation
Description: A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.~The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.
Study: NCT04246775

Intervention type: DEVICE
Group type: OTHER
Intervention: Peristeen
Description: rectal irrigation
Study: NCT03951831

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: REGN2810
Description: Cemiplimab (REGN 2810) is administered starting at week 4 at a dose of 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Degarelix
Description: Degarelix is administered subcutaneously (SC) at a dose of 240mg once.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuprolide Acetate
Description: Leuprolide acetate is provided at a dose of 22.5mg SC every 3 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: Docetaxel is administered starting at week 10 at a dose of 75 mg/m2 every 21 days for up to 6 cycles.
Study: NCT03276026

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sugammadex
Description: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Neostigmine
Description: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Study: NCT04238481

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pudexacianinium chloride
Description: Intravenous

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pudexacianinium chloride
Description: Intravenous

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pudexacianinium chloride
Description: Intravenous

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pudexacianinium chloride
Description: Intravenous
Study: NCT00979966

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temsirolimus
Description: 25 mg intravenously, once weekly infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunitinib
Description: 50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
Study: NCT03303170

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Sebacia Microparticles
Description: Topical microparticle suspension

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Nd:Yag Laser
Description: Laser delivering 1064 nm wavelength light
Study: NCT03750760

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alirocumab
Description: PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin 80mg
Description: 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin 80mg
Description: 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ezetimibe 10mg
Description: Cholesterol absorption inhibitor
Study: NCT01517165

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT01498393

Intervention type: DEVICE
Group type: OTHER
Intervention: Laser treatment
Description: Laser treatment to Improve the Appearance of Onychomycosis
Study: NCT01263678

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Coaching
Description: Decision support coaching will be provided after the participant has viewed the decision aid

Intervention type: OTHER
Group type: OTHER
Intervention: Usual Care
Description: Patient views DA and completes post DA survey.
Study: NCT00835198

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dapsone; Tretinoin
Description: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tretinoin
Description: Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
Study: NCT00350870

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: disulfiram
Description: 250mg per day of Disulfiram plus CBT

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo plus CBT
Study: NCT02697032

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bicalutamide
Description: 150mg

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: FDHT PET
Description: PET scan
Study: NCT01748032

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Cognitive training
Description: 20 minutes/day for 5 sequential working days

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Cognitive training
Description: 20 minutes/day for 5 sequential working days
Study: NCT02741024

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amodiaquine-Artesunate (ASAQ)
Description: Treatment on site with Amodiaquine-Artesunate according to the manufacturer's dose and instruction and follow-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Artemether-Lumefantrine (AL)
Description: Treatment on site with Artemether-lumefantrine combination according to the manufacturer's dose and instruction and follow-up for a period of 42 days.
Study: NCT00851500

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: K-604
Description: K-604 is given for 26 weeks
Study: NCT02989584

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atezolizumab
Study: NCT02989584

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Study: NCT03146962

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin C
Description: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Study: NCT00851500

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo tablets are given for 26 weeks
Study: NCT01937728

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: A: Peg-interferon alpha-2a & Ribavirin
Description: Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA \< 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: B: Peg-interferon alpha-2a & Ribavirin
Description: Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.~Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: C: Peg-interferon alpha-2a & Ribavirin
Description: Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.~Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: D: Peg-interferon alpha-2a & Ribavirin
Description: Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E: Peg-interferon alpha-2a & Ribavirin
Description: Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.~Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: F: Peg-interferon alpha-2a & Ribavirin
Description: Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.~Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
Study: NCT01315678

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.
Description: Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~* 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~* Administration time is approximately 13 minutes.~* liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
Description: 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~* Nebulization time is approximately 20 minutes for each administration.~* Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment
Study: NCT01516697

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: experimental
Description: Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Control
Description: Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
Study: NCT00719134

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Maxalt
Description: anti-migraine drug

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Maxalt
Description: anti-migraine drug

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Maxalt
Description: anti-migraine drug

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo pill
Description: placebo pills

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo pills
Description: placebo pills

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: placebo pills
Description: placebo pills
Study: NCT03146962

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin C
Description: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin C
Description: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin C
Description: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Study: NCT01720121

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Printed, digital video disc
Description: The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Printed, digital video disc
Description: The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.
Study: NCT01302600

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 0.1ml/kg once a day with food at dinner.
Study: NCT06792669

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Simulation training to evaluate the participants' manual skill improvement
Study: NCT04608487

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Intravenous infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Intravenous infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Axicabtagene Ciloleucel
Description: Intravenous infusion
Study: NCT00350870

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo plus Contingency Management
Description: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Disulfiram plus Contingency Management
Description: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Study: NCT03186508

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Optimize Sleep (OS)
Description: All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 sleep challenges (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Optimize Sleep-Plus (OS-Plus)
Description: All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 sleep challenges (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.
Study: NCT00822419

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: lidocaine
Description: lidocaine cream 5%

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ketamine
Description: ketamine 5%

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: non-drug cream
Description: will be put on the skin