TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A
B: Arm Label: Synbiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Synbiotic | Arm Label: Maltodextrin; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Maltodextrin | Intervention Type: DIETARY_SUPPLEMENT; Name: Synbiotic; Assigned to Arm(s): Synbiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Maltodextrin; Assigned to Arm(s): Maltodextrin
C: Arm Label: Vitamin D3 + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: fish oil | Arm Label: Vitamin D3 + fish oil placebo; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placebo | Arm Label: Vitamin D3 placebo + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: fish oil, Dietary Supplement: Vitamin D3 placebo | Arm Label: Vitamin D3 placebo + fish oil placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: fish oil; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 placebo + fish oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3 placebo; Assigned to Arm(s): Vitamin D3 placebo + fish oil, Vitamin D3 placebo + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Fish oil placebo; Assigned to Arm(s): Vitamin D3 + fish oil placebo, Vitamin D3 placebo + fish oil placebo
D: Intervention Type: BEHAVIORAL; Name: ascorbic acid, vitamin E, beta carotene, selenium, zinc; Assigned to Arm(s): N/A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: Arm Label: Lower fat diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Lower carbohydrate diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Walnut-rich diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Intervention Type: BEHAVIORAL; Name: Weight loss; Assigned to Arm(s): Lower carbohydrate diet, Lower fat diet, Walnut-rich diet
B: Intervention Type: DRUG; Name: Epanova™ (Omega-3 Free Fatty Acids); Assigned to Arm(s): N/A
C: Arm Label: 1.; Type: EXPERIMENTAL; Interventions: Drug: DHA (Docosahexaenoic Acid) | Arm Label: 2.; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: DHA (Docosahexaenoic Acid); Assigned to Arm(s): 1. | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2.
D: Arm Label: Vitamin D3 + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: fish oil | Arm Label: Vitamin D3 + fish oil placebo; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placebo | Arm Label: Vitamin D3 placebo + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: fish oil, Dietary Supplement: Vitamin D3 placebo | Arm Label: Vitamin D3 placebo + fish oil placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: fish oil; Assigned to Arm(s): Vitamin D3 + fish oil, Vitamin D3 placebo + fish oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3 placebo; Assigned to Arm(s): Vitamin D3 placebo + fish oil, Vitamin D3 placebo + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Fish oil placebo; Assigned to Arm(s): Vitamin D3 + fish oil placebo, Vitamin D3 placebo + fish oil placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma
Brief Summary: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.


Options:
A: Intervention Type: DRUG; Name: Lenalidomide; Assigned to Arm(s): N/A
B: Arm Label: 1 (PG - NM (MCH) 0.02%); Type: ACTIVE_COMPARATOR; Interventions: Drug: mechlorethamine-MCH (nitrogen mustard) | Arm Label: 2 (AP - MCH(NM) 0.02%); Type: ACTIVE_COMPARATOR; Interventions: Drug: mechlorethamine-MCH (nitrogen mustard) | Intervention Type: DRUG; Name: mechlorethamine-MCH (nitrogen mustard); Assigned to Arm(s): 1 (PG - NM (MCH) 0.02%), 2 (AP - MCH(NM) 0.02%)
C: Arm Label: Brentuximab vedotin; Type: EXPERIMENTAL; Interventions: Drug: Brentuximab Vedotin | Arm Label: Methotrexate or Bexarotene; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methotrexate, Drug: Bexarotene | Intervention Type: DRUG; Name: Brentuximab Vedotin; Assigned to Arm(s): Brentuximab vedotin | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Methotrexate or Bexarotene | Intervention Type: DRUG; Name: Bexarotene; Assigned to Arm(s): Methotrexate or Bexarotene
D: Arm Label: KW-0761; Type: EXPERIMENTAL; Interventions: Biological: KW-0761 | Arm Label: Vorinostat; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vorinostat | Intervention Type: BIOLOGICAL; Name: KW-0761; Assigned to Arm(s): KW-0761 | Intervention Type: DRUG; Name: Vorinostat; Assigned to Arm(s): Vorinostat

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study.
Brief Summary: The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used


Options:
A: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D3 | Arm Label: Control; Type: OTHER; Interventions: Dietary Supplement: Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Treatment | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Control
B: Arm Label: Healthy control - 5,000 IU vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: 5000IU vitamin D | Arm Label: Healthy control - 10,000 IU vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: 10000IU vitamin D | Arm Label: CIS - placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: CIS - 5,000 IU vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: 5000IU vitamin D | Arm Label: CIS - 10,000 IU vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: 10000IU vitamin D | Arm Label: Healthy control - placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: 5000IU vitamin D; Assigned to Arm(s): CIS - 5,000 IU vitamin D, Healthy control - 5,000 IU vitamin D | Intervention Type: DIETARY_SUPPLEMENT; Name: 10000IU vitamin D; Assigned to Arm(s): CIS - 10,000 IU vitamin D, Healthy control - 10,000 IU vitamin D | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): CIS - placebo, Healthy control - placebo
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Colecalciferol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsules | Intervention Type: DRUG; Name: Colecalciferol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo capsules; Assigned to Arm(s): 2
D: Arm Label: High dose vitamin D; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D3 | Arm Label: Low dose vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): High dose vitamin D | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Low dose vitamin D

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
Brief Summary: The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants \<1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.


Options:
A: Arm Label: Hand hygiene; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Hand hygiene plus gloving; Type: EXPERIMENTAL; Interventions: Other: Gloves | Intervention Type: OTHER; Name: Gloves; Assigned to Arm(s): Hand hygiene plus gloving
B: Intervention Type: PROCEDURE; Name: Reinforced isolation + Muciprocine; Assigned to Arm(s): N/A
C: Arm Label: Intervention Arm; Type: N/A; Interventions: N/A | Arm Label: Non-intervention - Usual Standard of Care; Type: N/A; Interventions: N/A
D: Intervention Type: PROCEDURE; Name: Bathing with Chlorhexidine Impregnated Washcloths; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
Brief Summary: The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.


Options:
A: Arm Label: Dual Focus Soft Contact Lens; Type: EXPERIMENTAL; Interventions: Device: Dual Focus Soft Contact Lens | Arm Label: Single Vision Soft Contact Lens; Type: PLACEBO_COMPARATOR; Interventions: Device: Single Vision Soft Contact Lens | Intervention Type: DEVICE; Name: Dual Focus Soft Contact Lens; Assigned to Arm(s): Dual Focus Soft Contact Lens | Intervention Type: DEVICE; Name: Single Vision Soft Contact Lens; Assigned to Arm(s): Single Vision Soft Contact Lens
B: Arm Label: Progressive Addition Lenses (PALs); Type: EXPERIMENTAL; Interventions: Other: Progressive Addition Lenses | Arm Label: Single Vision Lenses; Type: ACTIVE_COMPARATOR; Interventions: Other: single vision lenses | Intervention Type: OTHER; Name: Progressive Addition Lenses; Assigned to Arm(s): Progressive Addition Lenses (PALs) | Intervention Type: OTHER; Name: single vision lenses; Assigned to Arm(s): Single Vision Lenses
C: Intervention Type: DEVICE; Name: Bifocal Spectacle Lenses; Assigned to Arm(s): N/A
D: Arm Label: Single-vision glasses; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Orthokeratology with normal compression factor; Type: SHAM_COMPARATOR; Interventions: Device: Orthokeratology | Arm Label: Orthokeratology with increased compression factor; Type: ACTIVE_COMPARATOR; Interventions: Device: Orthokeratology | Intervention Type: DEVICE; Name: Orthokeratology; Assigned to Arm(s): Orthokeratology with increased compression factor, Orthokeratology with normal compression factor

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Intervention Promoting HPV Vaccination in Safety-net Clinics
Brief Summary: This randomized controlled trial is designed to evaluate whether a behavioral intervention that includes three components: 1) reminder letters and education materials delivered before the clinic visit, 2) telephone recalls after the visit for those who originally decline the vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1 and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls attending four Parkland primary care clinics in Dallas county.

Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the Intervention group than those in the General Adolescent Vaccine Brochure group.

Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among patients in the Intervention group who initially declined the vaccine than those in the General Adolescent Vaccine Brochure group who initially declined.

Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the Intervention group than those in the General Adolescent Vaccine Brochure group.


Options:
A: Arm Label: SMS Vaccine; Type: N/A; Interventions: Behavioral: SMS message reminding mothers to come for their scheduled vaccines | Arm Label: Usual care; Type: N/A; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: SMS message reminding mothers to come for their scheduled vaccines; Assigned to Arm(s): SMS Vaccine
B: Arm Label: Population-based Reminder/Recall; Type: EXPERIMENTAL; Interventions: Behavioral: Recall conducted centrally by local health department | Arm Label: Practice-based Reminder/Recall; Type: EXPERIMENTAL; Interventions: Behavioral: Recall conducted by private practices | Intervention Type: BEHAVIORAL; Name: Recall conducted by private practices; Assigned to Arm(s): Practice-based Reminder/Recall | Intervention Type: BEHAVIORAL; Name: Recall conducted centrally by local health department; Assigned to Arm(s): Population-based Reminder/Recall
C: Arm Label: General Adolescent Vaccine Brochure; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: General Adolescent Vaccine Brochure | Arm Label: HPV brochure, recall, reminders; Type: EXPERIMENTAL; Interventions: Behavioral: HPV brochure, recall, reminders | Intervention Type: BEHAVIORAL; Name: HPV brochure, recall, reminders; Assigned to Arm(s): HPV brochure, recall, reminders | Intervention Type: BEHAVIORAL; Name: General Adolescent Vaccine Brochure; Assigned to Arm(s): General Adolescent Vaccine Brochure
D: Arm Label: mailed reminder notice; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mailed influenza vaccination reminder notice | Arm Label: No reminder notice; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mailed influenza vaccination reminder notice; Assigned to Arm(s): mailed reminder notice

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
Brief Summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Options:
A: Arm Label: Canagliflozin 100 mg; Type: EXPERIMENTAL; Interventions: Drug: Canagliflozin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Canagliflozin; Assigned to Arm(s): Canagliflozin 100 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Standard glycemic control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Arm Label: Intensive glycemic control; Type: EXPERIMENTAL; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control
C: Arm Label: Dapagliflozin; Type: EXPERIMENTAL; Interventions: Drug: Dapagliflozin 10 mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo tablet | Intervention Type: DRUG; Name: Dapagliflozin 10 mg; Assigned to Arm(s): Dapagliflozin | Intervention Type: DRUG; Name: Placebo tablet; Assigned to Arm(s): Placebo
D: Arm Label: 1.5 mg Dulaglutide; Type: EXPERIMENTAL; Interventions: Drug: Dulaglutide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dulaglutide; Assigned to Arm(s): 1.5 mg Dulaglutide | 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: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
Brief Summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.


Options:
A: Arm Label: Linagliptin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Linagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Dapagliflozin; Type: EXPERIMENTAL; Interventions: Drug: Dapagliflozin 10 mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo tablet | Intervention Type: DRUG; Name: Dapagliflozin 10 mg; Assigned to Arm(s): Dapagliflozin | Intervention Type: DRUG; Name: Placebo tablet; Assigned to Arm(s): Placebo
D: Arm Label: Semaglutide; Type: EXPERIMENTAL; Interventions: Drug: Semaglutide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Semaglutide; Assigned to Arm(s): Semaglutide | 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 Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
Brief Summary: The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.


Options:
A: Arm Label: 300 IR; Type: EXPERIMENTAL; Interventions: Drug: 300 IR | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: 300 IR; Assigned to Arm(s): 300 IR | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: Birch pollen allergen extract; Type: EXPERIMENTAL; Interventions: Biological: Birch pollen allergen extract | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: BIOLOGICAL; Name: Birch pollen allergen extract; Assigned to Arm(s): Birch pollen allergen extract
C: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: (agent for immunotherapy) Staloral | Intervention Type: DRUG; Name: (agent for immunotherapy) Staloral; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1
D: Intervention Type: DRUG; Name: ALK HDM tablet; Assigned to Arm(s): N/A

Answer: B