TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02127112

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Block Allograft plus Matrix Allograft
Description: A cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Moldable Matrix Allograft
Description: The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Moldable Matrix Allograft
Description: The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.
Study: NCT00540995

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: allogeneic bone marrow transplantation
Description: Stem cell transplantation occurs on Day 0 after High Dose Therapy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: peripheral blood stem cell transplantation
Description: Stem cell transplantation occurs on Day 0 after High Dose Therapy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: peripheral blood stem cell transplantation
Description: Stem cell transplantation occurs on Day 0 after High Dose Therapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: tomotherapy
Description: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: tomotherapy
Description: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses
Study: NCT00387933

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: hydroxyurea

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: imatinib mesylate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vatalanib
Study: NCT02380794

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Danshen Gegen Capsule
Description: Danshen can dilate blood vessels, reduce the number of angina attacks and significantly improve endothelial function in patients with Coronary Angina Pectoris.~Gegen is also effective in dilating cardiovascular and cerebrovascular of the brain, and improving blood circulation. The main active ingredient of Gegen isoflavones is effective in dilating the coronary arteries, improving metabolism in normal and ischemic myocardium and reducing blood pressure, heart rate and myocardial oxygen consumption.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT03958396

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Remifentanil Infusion
Description: 15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Remifentanil Infusion
Description: 15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
Study: NCT02538627

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-151
Description: MM-151

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-121
Description: MM-121

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-121
Description: MM-121

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-121
Description: MM-121

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-141
Description: MM-141

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-141
Description: MM-141

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MM-141
Description: MM-141

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trametinib
Description: trametininb

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trametinib
Description: trametininb

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trametinib
Description: trametininb
Study: NCT04113486

Intervention type: OTHER
Intervention: Blood test
Description: About 4 ml of blood draw

Intervention type: OTHER
Intervention: Blood test
Description: About 4 ml of blood draw

Intervention type: OTHER
Intervention: Blood test
Description: About 4 ml of blood draw

Intervention type: OTHER
Intervention: Blood test
Description: About 4 ml of blood draw
Study: NCT02530073

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Description: This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).
Study: NCT02829957

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Apixaban
Description: 10mg BID for 7 days, then 5mg BID for three months
Study: NCT03481491

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: transcranial magnetic stimulation of the cerebellum
Description: The intervention will consist in a continuous theta burst stimulation of the cerebellum under neuronavigation.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: transcranial magnetic stimulation of the cerebellum
Description: The intervention will consist in a continuous theta burst stimulation of the cerebellum under neuronavigation.
Study: NCT03704662

Intervention type: RADIATION
Group type: OTHER
Intervention: Stereotactic Body Radiation Therapy
Description: Undergo SBRT
Study: NCT04776941

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Quality-of-Life Assessment
Description: Ancillary studies
Study: NCT03704662

Intervention type: RADIATION
Group type: OTHER
Intervention: Preoperative Fractionated Radiation Therapy and Chemotherapy
Description: Conventional concurrent chemotherapy and radiation therapy.
Study: NCT00149175

Intervention type: OTHER
Intervention: Blood sampling, skin biopsy
Description: Blood sampling, skin biopsy in the field of the medical follow-up

Intervention type: OTHER
Intervention: Blood sampling, skin biopsy
Description: Blood sampling, skin biopsy in the field of the medical follow-up

Intervention type: OTHER
Intervention: Blood sampling, skin biopsy
Description: Blood sampling, skin biopsy in the field of the medical follow-up
Study: NCT02829957

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rivaroxaban
Description: 15mg BID for 7 days, then 20mg daily for three months
Study: NCT01127477

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1: Hydroxyethyl starch 130/0.4, 6 %
Description: 1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.
Study: NCT00147537

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-751,871
Description: Phase 2 Arm A:~CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles
Study: NCT04649853

Intervention type: OTHER
Intervention: Standardized nursing care
Description: All patients will receive standardized evidence based nursing care
Study: NCT00147537

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Description: Phase 2 Arm A:~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles~Phase 2 Arm B:~Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carboplatin
Description: Phase 2 Arm A:~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles~Phase 2 Arm B:~Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-751,871
Description: Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Description: Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: carboplatin
Description: Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erlotinib
Description: Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
Study: NCT01206270

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Testosterone undecanoate
Description: Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Castor Oil
Description: 4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.
Study: NCT03389750

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous Challenge Drug
Description: Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous Challenge Drug
Description: Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous Challenge Drug
Description: Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Intravenous Challenge Drug
Description: Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).
Study: NCT04056637

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Choice of follow-up option
Description: Participant will be given the opportunity to choose from 3 follow-up options.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Multi-level pregnancy test
Description: The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
Study: NCT04146909

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Hyperinsulinemic-euglycemic clamp
Description: After an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Hyperinsulinemic-euglycemic clamp
Description: After an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit.
Study: NCT01507194

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ondansetron
Description: Single IV dose
Study: NCT04618965

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: control group
Description: Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Study: NCT01507194

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vestipitant
Description: Single IV dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vestipitant
Description: Single IV dose
Study: NCT04618965

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intrathecal dexmedetomidine
Description: Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Study: NCT01507194

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vestipitant
Description: Single IV dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vestipitant
Description: Single IV dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vestipitant
Description: Single IV dose
Study: NCT01596829

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Probiotic
Description: Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
Study: NCT04618965

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravenous dexmedetomidine
Description: Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.
Study: NCT03568071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOR 106
Description: The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOR 106
Description: The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOR 106
Description: The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOR 106
Description: The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.
Study: NCT01596829

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator
Study: NCT03568071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MOR 106
Description: The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.
Study: NCT00739219

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Apieron Insight eNO monitor
Description: The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
Study: NCT03466710

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Colposcopy
Description: Women will undergo colposcopy at 6 and 12 months after randomization. Those with CIN II will be managed according to standard of care. Those with CIN 1 6 months post randomization will have a second exam 6 months later and if still CIN I will have an exit colposcopy 6 months later.~All women in the Pap and HPV testing policies as well as all women in the colposcopy policy with CIN 1 after 2 exams will have an exit colposcopy 18 months after randomization. The exit colposcopy is a safeguard against the possibility of any false negatives in the follow up policies. The exit colposcopy will also establish the true numbers of CIN lesions in the 3 policies in order to determine their sensitivities and specificities. At the exit colposcopy,all will have an endocervical curettage,and either a minimum of 2 directed biopsies of any mucosal abnormality or in the event no abnormality is identified,2 random biopsies from the cervix.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pap test
Description: Women will receive Pap tests at 6 and 12 months after randomization. The Pap test will be prepared using the Thinprep® system which is the standard at Calgary Laboratory Services. Women with a Pap test result of malignant, HSIL, AIS, AGC, ASC-H, or LSIL-H (\>LSIL) at 6 or 12 months post randomization will be referred for colposcopic examination. Women with an ASC-US or LSIL result (\</=LSIL) will have a second follow up Pap test 6 months later (12 months post randomization). Those with a persistent result of ASC-US or LSIL or \>LSIL at 6 or 12 months will be referred for colposcopic examination. Outcome in the Pap policy is positive when the histopathology is \>/=CIN II. Results of \</=CIN I equal a negative outcome.~All other Pap test results will have an exit colposcopy 6 months later (18 months post randomization).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: HPV test
Description: Women will have an HPV test performed on a cervical scrape sample 12 months after randomization. Women with a positive result will be referred for colposcopy. Outcome in the HPV testing policy is positive when histopathology obtained at the colposcopic exam shows CIN II. All other results equal a negative outcome. HPV negative women will have an exit colposcopy 18 months post randomization. HPV testing will be performed using Cervista™HPV HR(Third Wave Technologies Inc./Hologic Inc, Madison, WI, USA).This HPV DNA test identifies 14 high risk types (16,18,31,33,35,39,45,51,52,56,58,59,66,68). Testing will be performed on the residual cervical scrape sample which is fixed in the PreservCyt® solution of the Thinprep® liquid based system(Hologic Inc, Marlborough, Ma, USA). Cervical samples may be held for up to 24 wks at room temperature before DNA extraction.This allows time for transportation without refrigeration.The samples will be sent by overnight express delivery to the laboratory.
Study: NCT04675346

Intervention type: OTHER
Intervention: Questionnaire
Description: Questionnaire

Intervention type: OTHER
Intervention: Questionnaire
Description: Questionnaire
Study: NCT03288467

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Root canal treatment with 5% NaOCl

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Root canal treatment with 1% NaOCl
Study: NCT01309425

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tapentadol (CG5503) ER two 100-mg TRF
Description: 200mg TRF single oral dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tapentadol (CG5503) ER 50-mg TRF
Description: 50mg TRF single oral dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tapentadol (CG5503) ER 25-mg TRF
Description: 25mg TRF single oral dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tapentadol (CG5503) ER 100-mg TRF
Description: 100mg TRF single oral dose
Study: NCT02867826

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cap
Description: Cap-assisted endoscopy
Study: NCT03240445

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ODM-203 (Period 1)
Description: ODM-203 400mg as tablets taken 30 minutes after food

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ODM-203 (Period 2)
Description: ODM-203 400mg as tablets taken 1 hour before a light breakfast

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ODM-203 (Periods 3-6)
Description: ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
Study: NCT03296345

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine
Description: The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
Study: NCT02588534

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: etanercept (ENBREL®) via auto-injector device
Description: single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)

Intervention type: OTHER
Group type: OTHER
Intervention: Etanercept (ENBREL®) via Manual injection
Description: single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via manual injection (reference treatment) to compare to the auto-injection
Study: NCT04583826

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CAVA
Description: CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.
Study: NCT00476541

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemtuzumab ozogamicin
Description: Two courses of Gemtuzumab vs. no further therapy
Study: NCT00728182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NA-1
Description: single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
Study: NCT02236767

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Neurostar Transcranial Magnetic Stimulation Therapy System
Description: Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).