TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00737867

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vinorelbine
Description: Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vinorelbine
Description: Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Description: Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
Study: NCT02977195

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NP137 DL and RP2D
Description: DOSE ESCALATION PART: 7 DL: NP137 was administrated every 2 weeks, as single agent by intravenous injection over 90 min with up to 7 ascending dose levels: Dose level 1: 1 mg/kg Dose level 2: 2 mg/kg Dose level 3: 4 mg/kg Dose level 4: 6 mg/kg Dose level 5: 9 mg/kg Dose level 6: 14 mg/kg Dose level 7: 20 mg/kg~EXPANSION PARTS: NP137 was administered every 2 weeks, as single agent by intravenous injection over 180 min at 14 mg/kg (RP2D defined in the Dose escalation part).~FOR ALL PARTS AND COHORT: Treatment will be administered as long as patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Study: NCT04018911

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hearing Aid with standard Noise Reduction (NR_1)
Description: Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Hearing Aid with NR_2
Description: Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Hearing Aid with NR_3
Description: Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hearing Aid with NR_4
Description: Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.
Study: NCT00767377

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EOF5
Description: epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks
Study: NCT00505466

Intervention type: BEHAVIORAL
Intervention: Genetic Counseling
Description: Genetic counseling conducted in person, by telephone with an M. D. Anderson Genetic Counselor, or with a local Genetic Counselor in conference with the M. D. Anderson Genetic Counselor.
Study: NCT04462952

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Adavosertib (AZD1775)
Description: Adavosertib taken orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Adavosertib (AZD1775)
Description: Adavosertib taken orally
Study: NCT02158780

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Scrotal Orchidopexy
Description: Single incision

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Inguinal Orchidopexy
Description: Double Incision (Standard)
Study: NCT04619485

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CO2 LASER
Description: 5 SESSIONS OF CO2 VAGINAL LASER

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: CO2 SHAM LASER
Description: 5 SESSIONS OF CO2 VAGINAL SHAM LASER
Study: NCT04940143

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botulinum toxin type-A (Onabotulinum toxin type-A)
Description: Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical Therapy
Description: After the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training.
Study: NCT01965132

Intervention type: DRUG
Intervention: Biologic or targeted synthetic DMARD
Study: NCT01192022

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: TachoSil®
Description: Intraoperative application as secondary hemostatic treatment

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Surgicel® Original
Description: Intraoperative application as secondary hemostatic treatment
Study: NCT02830880

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FACBC PET-CT
Description: Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: MRI, CT, or Bone Scan
Description: Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
Study: NCT04048915

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Long live drama
Description: The interactive live 90-minute drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.~Worksheets were given to all students and encouraged to finish the worksheets with their parents.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Short live drama
Description: The interactive live 60-minute drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.~Worksheets were given to all students and encouraged to finish the worksheets with their parents.
Study: NCT01892358

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: SKIN Intervention

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Treatment as Usual
Study: NCT02631330

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Multicomponent physical activity
Description: Balance, muscle strength and aerobic capacity will be increased in intensity according Training Intervention in a Controlled Population of Frail Elderly (EMTIFE) study NCT02331459
Study: NCT01464476

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azimilide Dihydrochloride
Description: Azimilide 75 mg. Once daily, oral administration

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Dose-matched placebo. Once daily, oral administration
Study: NCT04096911

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sintilimab
Description: Sintilimab 200 mg intravenously every 3 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: quadrivalent HPV vaccine
Description: The first dose of quadrivalent HPV vaccine intramuscularly at the day before the first dose of Sintilimab ，the second and third doses of quadrivalent HPV vaccine intramuscularly at the 60th and 180th days respectively
Study: NCT02805777

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CPAP mask
Description: A new vent CPAP mask system will be used in this trial

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CPAP mask
Description: A new vent CPAP mask system will be used in this trial
Study: NCT02787863

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Prevenar-13
Description: Conjugate 13 serotype pneumococcal vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pneumo-23
Description: Polysaccharide 23-valent pneumococcal vaccine.
Study: NCT01368835

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ulthera treatment
Description: treatment of cheeks and upper neck area of face
Study: NCT01396447

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo was supplied in capsules.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cariprazine
Description: Cariprazine was supplied in capsules.
Study: NCT01700556

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 3 preventive home visits by a nurse
Description: The dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: 3 preventive home visits by a nurse
Description: The dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course.
Study: NCT02056483

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Screening-based nurse navigation
Description: Screening-based nurse navigation for breast cancer rehabilitation
Study: NCT02823977

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: Blinded study drug administered to experimental arm

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Open-label study drug administered to both arms

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dexmedetomidine
Description: Open-label study drug administered to both arms

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline
Description: Blinded comparator administered to control arm
Study: NCT00769002

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield
Description: Flu vaccine

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield
Description: Flu vaccine

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield
Description: Flu vaccine

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield
Description: Flu vaccine

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield - same arm
Description: Flu vaccine

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FluShield - opposite arm
Description: Flu vaccine

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Blood Draws
Description: 50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Blood Draws
Description: 50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Blood Draws
Description: 50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Blood Draws
Description: 50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: FDG PET-CT Scan
Description: PET scan

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: FDG PET-CT Scan
Description: PET scan

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: FDG PET-CT Scan
Description: PET scan

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: FDG PET-CT Scan
Description: PET scan

Intervention type: GENETIC
Group type: ACTIVE_COMPARATOR
Intervention: Cytokine Profiling
Description: Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Intervention type: GENETIC
Group type: ACTIVE_COMPARATOR
Intervention: Cytokine Profiling
Description: Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Intervention type: GENETIC
Group type: ACTIVE_COMPARATOR
Intervention: Cytokine Profiling
Description: Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination

Intervention type: GENETIC
Group type: ACTIVE_COMPARATOR
Intervention: Cytokine Profiling
Description: Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination
Study: NCT05266937

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Atezolizumab,Paclitaxel, Carboplatin
Description: Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle + Carboplatin area under the curve 2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle + nab-Paclitaxel at a dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle.~In the absence of disease progression or unacceptable toxicity, study treatments will continue until the end of the study (2 years from last patient enrolled or study termination by the Sponsor).
Study: NCT02148380

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pemetrexed plus carboplatin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pemetrexed plus carboplatin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gefitinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gefitinib
Study: NCT01457807

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3241 ER formulation 1
Description: Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo will be administered with the same intervention scheme as intervention 1 and 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3241 Alternative titration scheme with formulation 1 or 2
Description: 50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
Study: NCT01396447

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cariprazine
Description: Cariprazine was supplied in capsules.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cariprazine
Description: Cariprazine was supplied in capsules.
Study: NCT05086029

Intervention type: DIAGNOSTIC_TEST
Intervention: Superb Microvascular Imaging
Description: Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.

Intervention type: DIAGNOSTIC_TEST
Intervention: Superb Microvascular Imaging
Description: Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.
Study: NCT01457807

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD3241 Alternative titration scheme with formulation 1 or 2
Description: 50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
Study: NCT01493453

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: aCD19z cells, IL2, pre conditioning Cyclophosphamide & Fludarabine
Description: aCD19z T cells IV Day 1. The dose of aCD19z T cells will be determined by dose escalation scheme, starting at 10\*9 IL2 given as 15 minute IV infusion every eight hours for up to 12 doses Cyclophosphamide (C) 15mg/kg day -7 and day -6, Fludarabine (F) 25mg/m2 day -5 to day -1.
Study: NCT03867578

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: HR-MRI
Description: The first 5 patients will undergo HR-MRI scans using different sequence parameters. Results in these patients will then be assessed along with standard CT Imaging to determine which sequences appear to best identify peritoneal disease. The optimal HR-MRI sequences will then be used for the next 19 patients in the Testing phase to formally define their performance compared to standard imaging.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: HR-MRI
Description: The first 5 patients will undergo HR-MRI scans using different sequence parameters. Results in these patients will then be assessed along with standard CT Imaging to determine which sequences appear to best identify peritoneal disease. The optimal HR-MRI sequences will then be used for the next 19 patients in the Testing phase to formally define their performance compared to standard imaging.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Standard CT Imaging
Description: Standard CT scans will be performed for preoperative imaging in all patients.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Ultrasound
Description: Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner
Study: NCT03899779

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Face-to-face hypnotherapy
Description: 12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Online hypnotherapy
Description: 12 weeks treatment with online hypnotherapy

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Online psychoeducation
Description: 12 weeks treatment with online psychoeducation
Study: NCT03991351

Intervention type: OTHER
Intervention: Exposure to images
Description: Exposure to images
Study: NCT02101723

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: MNP + Zn/Fe
Description: Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: MNP + Zn
Description: Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo powder without micronutrients
Study: NCT03051555

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 18F-FDG PET/ CT
Description: 18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was \<200 mg/ dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10min/bed).
Study: NCT02137564

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gamma secretase inhibitor PF-03084014
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT01309074

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pregabalin-Lyrica
Description: Pregabalin in a dose up to 300mg/day in BID dosing.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sertraline
Description: Sertraline in a dose up to 200mg/day in BID dosing.