TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
Brief Summary: A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Arm Label: Yoga; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weekly yoga classes | Arm Label: Physical Therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Individual physical therapy treatment | Arm Label: Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Education | Intervention Type: BEHAVIORAL; Name: Weekly yoga classes; Assigned to Arm(s): Yoga | Intervention Type: BEHAVIORAL; Name: Individual physical therapy treatment; Assigned to Arm(s): Physical Therapy | Intervention Type: BEHAVIORAL; Name: Education; Assigned to Arm(s): Education
B: Arm Label: RESTORE Intervention; Type: EXPERIMENTAL; Interventions: Other: RESTORE Intervention | Arm Label: Control Group 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: RESTORE Intervention; Assigned to Arm(s): RESTORE Intervention
C: Arm Label: Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Education | Arm Label: Yoga; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Yoga | Intervention Type: BEHAVIORAL; Name: Education; Assigned to Arm(s): Education | Intervention Type: BEHAVIORAL; Name: Yoga; Assigned to Arm(s): Yoga
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Yoga | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Exercise | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-care book recommendations | Intervention Type: BEHAVIORAL; Name: Yoga; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): 2 | Intervention Type: BEHAVIORAL; Name: Self-care book recommendations; Assigned to Arm(s): 3

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Project Dulce: Developmental Understanding and Legal Collaboration for Everyone
Brief Summary: Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.


Options:
A: Arm Label: Intervention Group Year 1; Type: EXPERIMENTAL; Interventions: Behavioral: 4 Pillars Immunization Toolkit | Arm Label: Control Group Year 1; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: 4 Pillars Immunization Toolkit; Assigned to Arm(s): Intervention Group Year 1
B: Arm Label: Intervention Clinics; Type: EXPERIMENTAL; Interventions: Behavioral: Academic Detailing | Arm Label: Control Clinics; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Academic Detailing; Assigned to Arm(s): Intervention Clinics
C: Arm Label: Dulce family partner intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Project dulce | Arm Label: Safety intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Safety intervention | Intervention Type: BEHAVIORAL; Name: Project dulce; Assigned to Arm(s): Dulce family partner intervention | Intervention Type: BEHAVIORAL; Name: Safety intervention; Assigned to Arm(s): Safety intervention
D: Arm Label: P3 Vaccine Promotion Package; Type: EXPERIMENTAL; Interventions: Behavioral: P3 Vaccine Promotion Package. | Arm Label: No P3 vaccine promotion package intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: P3 Vaccine Promotion Package.; Assigned to Arm(s): P3 Vaccine Promotion Package

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM
Brief Summary: The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.


Options:
A: Arm Label: Lifestyle Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Counseling | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle Counseling; Assigned to Arm(s): Lifestyle Counseling
B: Arm Label: Lifestyle intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): Lifestyle intervention
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): Intervention
D: Arm Label: Lifestyle intervention; Type: EXPERIMENTAL; Interventions: Other: Lifestyle intervention, Behavioral: Physical activity, dietetic counselling | Arm Label: Control; Type: NO_INTERVENTION; Interventions: Other: Control | Intervention Type: OTHER; Name: Lifestyle intervention; Assigned to Arm(s): Lifestyle intervention | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Physical activity, dietetic counselling; Assigned to Arm(s): Lifestyle intervention

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
Brief Summary: The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: palonosetron | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: granisetron hydrochloride | Intervention Type: DRUG; Name: palonosetron; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: granisetron hydrochloride; Assigned to Arm(s): 2
B: Arm Label: Placebo + Granisetron + Dexamethasone; Type: PLACEBO_COMPARATOR; Interventions: Drug: Granisetron, Drug: Dexamethasone, Drug: Placebo | Arm Label: Rolapitant; Type: EXPERIMENTAL; Interventions: Drug: Rolapitant, Drug: Granisetron, Drug: Dexamethasone | Intervention Type: DRUG; Name: Rolapitant; Assigned to Arm(s): Rolapitant | Intervention Type: DRUG; Name: Granisetron; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone, Rolapitant | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone, Rolapitant | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Granisetron + Dexamethasone
C: Arm Label: Standard therapy; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Aprepitant / Fosaprepitant therapy; Type: EXPERIMENTAL; Interventions: Drug: Aprepitant / Fosaprepitant | Intervention Type: DRUG; Name: Aprepitant / Fosaprepitant; Assigned to Arm(s): Aprepitant / Fosaprepitant therapy
D: Arm Label: Fosaprepitant Regimen; Type: EXPERIMENTAL; Interventions: Drug: Fosaprepitant dimeglumine, Drug: Dexamethasone, Drug: Ondansetron, Drug: Dexamethasone Placebo, Drug: Ondansetron Placebo, Drug: Rescue Therapy | Arm Label: Control Regimen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fosaprepitant Placebo, Drug: Dexamethasone, Drug: Ondansetron, Drug: Rescue Therapy | Intervention Type: DRUG; Name: Fosaprepitant dimeglumine; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Fosaprepitant Placebo; Assigned to Arm(s): Control Regimen | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen | Intervention Type: DRUG; Name: Ondansetron; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen | Intervention Type: DRUG; Name: Dexamethasone Placebo; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Ondansetron Placebo; Assigned to Arm(s): Fosaprepitant Regimen | Intervention Type: DRUG; Name: Rescue Therapy; Assigned to Arm(s): Control Regimen, Fosaprepitant Regimen

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.
Brief Summary: A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.


Options:
A: Arm Label: Smartphone Application; Type: EXPERIMENTAL; Interventions: Other: Smartphone Application | Arm Label: Usual primary care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Smartphone Application; Assigned to Arm(s): Smartphone Application
B: Arm Label: Telemonitoring group; Type: EXPERIMENTAL; Interventions: Procedure: Telemonitoring | Arm Label: Control group; Type: OTHER; Interventions: Other: control group | Intervention Type: PROCEDURE; Name: Telemonitoring; Assigned to Arm(s): Telemonitoring group | Intervention Type: OTHER; Name: control group; Assigned to Arm(s): Control group
C: Arm Label: Control: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Other: Control: Lifestyle counseling | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Intervention group, Other: Control: Lifestyle counseling | Intervention Type: OTHER; Name: Intervention group; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Control: Lifestyle counseling; Assigned to Arm(s): Control: Lifestyle counseling, Intervention group
D: Arm Label: Control Group (CG); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Control Group (CG) | Arm Label: Moderate physical activity group (MPA); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Moderate physical activity group (MPA) | Arm Label: Intense physical activity group (IPA); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intense physical activity group (IPA) | Intervention Type: BEHAVIORAL; Name: Control Group (CG); Assigned to Arm(s): Control Group (CG) | Intervention Type: BEHAVIORAL; Name: Moderate physical activity group (MPA); Assigned to Arm(s): Moderate physical activity group (MPA) | Intervention Type: BEHAVIORAL; Name: Intense physical activity group (IPA); Assigned to Arm(s): Intense physical activity group (IPA)

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
Brief Summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Pregabalin; Type: OTHER; Interventions: Drug: Pregabalin | Arm Label: GEn 1200mg/day; Type: EXPERIMENTAL; Interventions: Drug: GEn 1200mg/day | Arm Label: GEn 2400mg/day; Type: EXPERIMENTAL; Interventions: Drug: GEn 2400mg/day | Arm Label: GEn 3600mg/day; Type: EXPERIMENTAL; Interventions: Drug: GEn 3600mg/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: GEn 1200mg/day; Assigned to Arm(s): GEn 1200mg/day | Intervention Type: DRUG; Name: GEn 2400mg/day; Assigned to Arm(s): GEn 2400mg/day | Intervention Type: DRUG; Name: GEn 3600mg/day; Assigned to Arm(s): GEn 3600mg/day | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): Pregabalin
B: Arm Label: 1: Pregabalin; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Arm Label: 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): 1: Pregabalin | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2: Placebo
C: Arm Label: ABT-639; Type: EXPERIMENTAL; Interventions: Drug: ABT-639 | Arm Label: pregabalin; Type: ACTIVE_COMPARATOR; Interventions: Drug: pregabalin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ABT-639; Assigned to Arm(s): ABT-639 | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): pregabalin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Pregablain CR tablet 82.5 to 660mg; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): Pregablain CR tablet 82.5 to 660mg | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.


Options:
A: Arm Label: Belimumab; Type: EXPERIMENTAL; Interventions: Drug: Belimumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Belimumab; Assigned to Arm(s): Belimumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Belimumab 1 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Belimumab 1 mg/kg | Arm Label: Belimumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Belimumab 10 mg/kg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Belimumab 1 mg/kg; Assigned to Arm(s): Belimumab 1 mg/kg | Intervention Type: DRUG; Name: Belimumab 10 mg/kg; Assigned to Arm(s): Belimumab 10 mg/kg
C: Arm Label: Belimumab 1 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Belimumab 1 mg/kg | Arm Label: Belimumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Belimumab 10 mg/kg | Intervention Type: BIOLOGICAL; Name: Belimumab 1 mg/kg; Assigned to Arm(s): Belimumab 1 mg/kg | Intervention Type: BIOLOGICAL; Name: Belimumab 10 mg/kg; Assigned to Arm(s): Belimumab 10 mg/kg
D: Arm Label: Belimumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Belimumab | Intervention Type: BIOLOGICAL; Name: Belimumab; Assigned to Arm(s): Belimumab 10 mg/kg

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)
Brief Summary: A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally


Options:
A: Arm Label: Eplerenone arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Eplerenone | Intervention Type: DRUG; Name: Eplerenone; Assigned to Arm(s): Eplerenone arm
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Eplerenone | Arm Label: 2; Type: NO_INTERVENTION; Interventions: Drug: Eplerenone | Intervention Type: DRUG; Name: Eplerenone; Assigned to Arm(s): 1, 2
C: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: BAY94-8862 | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Drug: BAY94-8862 | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Drug: BAY94-8862 | Arm Label: Arm 4; Type: EXPERIMENTAL; Interventions: Drug: BAY94-8862 | Arm Label: Arm 5; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Arm 6; Type: ACTIVE_COMPARATOR; Interventions: Drug: Spironolactone | Intervention Type: DRUG; Name: BAY94-8862; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: BAY94-8862; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: BAY94-8862; Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: BAY94-8862; Assigned to Arm(s): Arm 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arm 5 | Intervention Type: DRUG; Name: Spironolactone; Assigned to Arm(s): Arm 6
D: Arm Label: Spironolactone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Spironolactone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Spironolactone; Assigned to Arm(s): Spironolactone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
Brief Summary: The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).


Options:
A: Arm Label: M281 administered every 4 weeks (double-blind period); Type: EXPERIMENTAL; Interventions: Drug: M281, Drug: Placebo | Arm Label: M281 administered every 2 weeks (double-blind period); Type: EXPERIMENTAL; Interventions: Drug: M281 | Arm Label: Placebo administered every 2 weeks (double-blind period); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: M281 administered every 4 weeks (open-label extension period); Type: EXPERIMENTAL; Interventions: Drug: M281 | Arm Label: M281 administered every 2 weeks (open-label extension period); Type: EXPERIMENTAL; Interventions: Drug: M281 | Intervention Type: DRUG; Name: M281; Assigned to Arm(s): M281 administered every 2 weeks (double-blind period), M281 administered every 2 weeks (open-label extension period), M281 administered every 4 weeks (double-blind period), M281 administered every 4 weeks (open-label extension period) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): M281 administered every 4 weeks (double-blind period), Placebo administered every 2 weeks (double-blind period)
B: Arm Label: Treatment arm; Type: EXPERIMENTAL; Interventions: Drug: Bendamustine, Rituximab | Intervention Type: DRUG; Name: Bendamustine, Rituximab; Assigned to Arm(s): Treatment arm
C: Arm Label: Eculizumab; Type: EXPERIMENTAL; Interventions: Drug: Eculizumab | Intervention Type: DRUG; Name: Eculizumab; Assigned to Arm(s): Eculizumab
D: Intervention Type: DRUG; Name: prednisone, low dose rituximab; Assigned to Arm(s): N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
Brief Summary: On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications.

The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.


Options:
A: Intervention Type: PROCEDURE; Name: Adult male circumcision; Assigned to Arm(s): N/A
B: Arm Label: valacyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Valacyclovir | Arm Label: high dose valacyclovir; Type: EXPERIMENTAL; Interventions: Drug: valacyclovir | Intervention Type: DRUG; Name: valacyclovir; Assigned to Arm(s): high dose valacyclovir | Intervention Type: DRUG; Name: Valacyclovir; Assigned to Arm(s): valacyclovir
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Acyclovir | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Acyclovir placebo | Intervention Type: DRUG; Name: Acyclovir; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Acyclovir placebo; Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: valacyclovir | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: valacyclovir; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2

Answer: B