TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01918072

Intervention type: OTHER
Intervention: Clinical innovation
Description: Technology-based intervention that combines interactive communication with women's health specialists and ongoing education

Intervention type: OTHER
Intervention: Clinical innovation
Description: Technology-based intervention that combines interactive communication with women's health specialists and ongoing education

Intervention type: OTHER
Intervention: Clinical innovation
Description: Technology-based intervention that combines interactive communication with women's health specialists and ongoing education
Study: NCT04517773

Intervention type: OTHER
Intervention: writting test
Description: Patients will be invitated to fill a questionary about self-autonomy
Study: NCT04260386

Intervention type: OTHER
Intervention: Non-Interventional
Description: During the cardiac arrest scenario, the delegates observing will be asked to refer to the maternal cardiac arrest proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. The proforma is accompanied by explanatory notes on how to use it.~Delegates (observers plus scribes) will then be asked to complete a questionnaire, seeking their opinions on the usefulness of the proforma. Questionnaires will be linked to the written consent forms by a participant ID number.
Study: NCT03142373

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: CV4 technique

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: RR technique

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo treatment
Study: NCT04283526

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MBG453
Description: Intravenous. 600mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MBG453
Description: Intravenous. 600mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MBG453
Description: Intravenous. 600mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MBG453
Description: Intravenous. 600mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NIS793
Description: Intravenous. 2100mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NIS793
Description: Intravenous. 2100mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NIS793
Description: Intravenous. 2100mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NIS793
Description: Intravenous. 2100mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spartalizumab
Description: Intravenous. 300mg. Every first day of a 21-day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Description: Intravenous. Starting dose: 5mg/m2 (dose cap at 20mg/m2). On days 1, 2 and 3 of a 42-day cycle
Study: NCT01865500

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Metil prednisolone
Study: NCT00381888

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fondaparinux sodium
Description: Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Study: NCT01583738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: V0251
Description: single dose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: single dose
Study: NCT02645539

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: intravascular ventricular assist system (iVAS)
Description: A mechanical circulatory support device using the principles of counterpulsation.
Study: NCT00709540

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ACE-011 or placebo
Description: multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)
Study: NCT00854971

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: TKCell
Description: Biological/Vaccine: TKCell
Study: NCT02007811

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: allogeneic donor derived B-lymphocytes
Description: CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
Study: NCT02983877

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: iTAB-CV
Description: Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention.~In the second stage for the following month, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.
Study: NCT00945113

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: One-week speech therapy group
Description: One-week cross-district speech therapy group for older children (aged 8 to 15) who stammer
Study: NCT01101334

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CS-7017
Description: CS-7017, Two 0.25mg Tablets administered twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erlotinib
Description: Erlotinib; One 150mg tablet administered once daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: erlotinib
Description: Erlotinib; One 150mg tablet administered once daily
Study: NCT01391676

Intervention type: PROCEDURE
Intervention: trabeculectomy
Description: postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography
Study: NCT01837498

Intervention type: DRUG
Intervention: Neostigmine
Description: At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine

Intervention type: DRUG
Intervention: Sugammadex
Description: At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex
Study: NCT00610571

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Topotecan and Temodar
Description: Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.~Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.
Study: NCT01502306

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Telephone counseling
Description: Telephone counseling is conducted in the appropriate language (Spanish and English) by counselors at the California Smokers' Helpline. Counselors use a structured protocol and there is a record for each call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine patches
Description: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Incentive
Description: They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
Study: NCT03090971

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diclofenac Sodium
Description: Following microporation, treatment neurofibromas will receive treatment with topical diclofenac

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Saline Solution
Description: Following microporation, control neurofibromas will receive treatment with topical saline
Study: NCT00320814

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VEGF Trap-Eye
Description: single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
Study: NCT01543334

Intervention type: BIOLOGICAL
Intervention: Blood sampling
Description: Blood samples will be harvested in one sequence at any time during the week set for the study. In patients receiving multiple antibiotics, multiple samples can be made (without exceeding the study of three antibiotics, ie a maximum of 6 tubes per patient). Two 3-ml tubes of blood will be collected for beta-lactams and glycopeptides (Sample A taken at half the time of the dosing interval and sample B at 30 minutes before the next dose). When patients receive continuous antibiotic treatment, both samples must be made at least 6 hours apart.
Study: NCT01821729

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRINOX
Description: Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan
Description: Taken orally every day during Phase I for all 8 cycles

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Proton Beam Radiation
Description: 30-45 minutes per day, daily Monday-Friday
Study: NCT04780984

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tiotropium bromide inhalation solution
Description: Tiotropium bromide inhalation solution

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tiotropium bromide inhalation solution
Description: Tiotropium bromide inhalation solution

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tiotropium bromide inhalation solution
Description: Tiotropium bromide inhalation solution

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tiotropium bromide inhalation solution
Description: Tiotropium bromide inhalation solution

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo comparator
Study: NCT03120598

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: ATTC strategy
Description: Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ATTC strategy
Description: Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ISF strategy
Description: Implementation \& Sustainment Facilitation (ISF) strategy: An organization-focused strategy that includes 7 discrete strategies (e.g., use of an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change).
Study: NCT02826798

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VBI-1501A 0.5 μg
Description: VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VBI-1501A 1.0 μg
Description: VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VBI-1501A 2.0 μg
Description: VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VBI-1501 1.0 μg
Description: VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Study: NCT02135822

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nanoparticle albumin-bound paclitaxel
Description: Nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine
Description: Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
Study: NCT01059188

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cetuximab
Description: 400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: 50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Description: 85 mg/m2 day 1 of 21 day cycles, for 3 cycles

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: 44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgery
Description: Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.
Study: NCT03014817

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasonically activated scalpel
Description: Dissection with ultrasonically activated scalpel

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Electrocautery
Description: Dissection with electrocautery
Study: NCT02543788

Intervention type: PROCEDURE
Group type: OTHER
Intervention: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG

Intervention type: PROCEDURE
Group type: OTHER
Intervention: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
Study: NCT01828359

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amosartan® tab
Description: comparison of different combination of anti-hypertension drug

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cozaar® plus pro tab
Description: comparison of different combination of anti-hypertension drug
Study: NCT00458354

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Spinal Sealant
Description: Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Standard Methods of Closing of the Dura
Description: Standard methods such as the closing of the dura with stitches.
Study: NCT02658708

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Horne-Ostberg Morningness-Eveningness Questionnaire

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Daily Fatigue and Sleep Log
Description: * Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness~* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Daily Fatigue and Sleep Log
Description: * Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness~* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)
Study: NCT02647489

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PAMVAC

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Alhydrogel

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Alhydrogel

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Alhydrogel

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Alhydrogel

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-LSQ

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-LSQ

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02388711

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: C-TraC Intervention
Description: C-TraC utilizes a nurse case manager to coordinate the patient's transitional care through active participation in inpatient multidisciplinary discharge rounds, a single brief protocol-driven inpatient encounter, and 1-4 protocol-driven post-hospital telephone calls with the patient/caregiver using spaced retrieval techniques.
Study: NCT02083653

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sym004 (12 mg/kg)
Description: Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sym004 (9/6 mg/kg)
Description: Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Best Supportive Care (BSC)
Description: BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluorouracil (5-FU)
Description: 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.
Study: NCT03304184

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Photac-fil
Description: Application of a tooth colored filling in a non-cavitated dental lesion.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Biodentine
Description: Application of a white colored filling in a non-cavitated dental lesion.
Study: NCT05242133

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegylated interferon beta-1a
Description: Pegylated interferon beta-1a (CinnaGen) autoinjector (Physioject™),125 mcg, subcutaneous (SC) injection, every 2 weeks, for 24 months

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Interferon Beta-1A Prefilled Syringe
Description: Interferon Beta-1A Prefilled Syringe, CinnoVex® (CinnaGen), 30 mcg, intramuscular injection, once a week, for 24 months
Study: NCT05907187

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cervical Cancer Prevention Education
Description: Participants will receive in-person, one-time health education on the importance of cervical cancer screening using a short intervention/educational script; and motivation to encourage women to have human papillomavirus (HPV) screening. Participants will also be informed of the nature and risks of HPV infection, and the importance of seeing a doctor including having a gynecologic exam.
Study: NCT02328157

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Vitrectomy with cataract surgery and toric IOL

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Vitrectomy with cataract surgery and common IOL
Study: NCT00366860

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Soy bread
Study: NCT03994406

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CLM2 topical gel
Description: Active topical gel for forehead dermal application

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo topical gel
Description: Placebo topical gel for forehead dermal application
Study: NCT02494401

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Internet-based self-management program

Intervention type: OTHER
Group type: OTHER
Intervention: Scleroderma book
Study: NCT03030274

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Occlutech AFR device
Description: Catheter-guided placement of an AFR device following balloon atrial septostomy.
Study: NCT02801526

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-330 16/5mg - A

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Candesartan 16mg and Amlodipine 5mg
Study: NCT02074319

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Treatment as usual or standard treatment for psychosis will be common in all arms

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Methotrexate
Description: Treatment as usual or standard treatment for psychosis will be common in all arms
Study: NCT01064635

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Letrozole
Description: letrozole for 2-3 years after Tam

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Letrozole for 5 years after Tam
Study: NCT02179749

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mifepristone 1200 mg daily
Description: Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standardized behavioral therapy
Description: Standardized behavioral therapy 1 time per week for 8 week duration.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Standardized behavioral therapy
Description: Standardized behavioral therapy 1 time per week for 8 week duration.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo tablets, Four tablets daily/am for 1-week duration.
Study: NCT00675870

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NRX 195183 Soft Gelatin Capsule
Description: Daily oral NRX 195183 administration for 90 days to assess CR rate. Patients with CR may continue maintenance therapy after a 2-week drug holiday. Maintenance therapy will consist of two 3-month daily oral NRX 195183 administration separated by a 2-week drug holiday.