TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Home Blood Pressure Monitoring Program
Brief Summary: The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.


Options:
A: Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Self-management; Type: EXPERIMENTAL; Interventions: Other: Self-monitoring and adjustment of oral anticoagulation | Intervention Type: OTHER; Name: Self-monitoring and adjustment of oral anticoagulation; Assigned to Arm(s): Self-management
B: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Home Blood Pressure Monitoring Group; Type: EXPERIMENTAL; Interventions: Behavioral: Home Blood Pressure Monitoring | Intervention Type: BEHAVIORAL; Name: Home Blood Pressure Monitoring; Assigned to Arm(s): Home Blood Pressure Monitoring Group
C: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: Other: Case Management | Arm Label: Case Management; Type: EXPERIMENTAL; Interventions: Other: Case Management | Intervention Type: OTHER; Name: Case Management; Assigned to Arm(s): Case Management, Usual Care
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Telemonitors and pharmacy management; Type: EXPERIMENTAL; Interventions: Other: Telemonitors and pharmacy management | Intervention Type: OTHER; Name: Telemonitors and pharmacy management; Assigned to Arm(s): Telemonitors and pharmacy management

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.


Options:
A: Arm Label: Vortioxetine 10 mg or 20 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine (Lu AA21004) | Arm Label: Agomelatine 25 mg or 50 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Agomelatine | Intervention Type: DRUG; Name: Vortioxetine (Lu AA21004); Assigned to Arm(s): Vortioxetine 10 mg or 20 mg | Intervention Type: DRUG; Name: Agomelatine; Assigned to Arm(s): Agomelatine 25 mg or 50 mg
B: Arm Label: Vortioxetine (Lu AA21004); Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine (Lu AA21004) | Arm Label: Venlafaxine extended release; Type: ACTIVE_COMPARATOR; Interventions: Drug: Venlafaxine extended release | Intervention Type: DRUG; Name: Vortioxetine (Lu AA21004); Assigned to Arm(s): Vortioxetine (Lu AA21004) | Intervention Type: DRUG; Name: Venlafaxine extended release; Assigned to Arm(s): Venlafaxine extended release
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Vortioxetine: 2.5 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine (Lu AA21004) | Arm Label: Vortioxetine: 5 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine (Lu AA21004) | Arm Label: Vortioxetine: 10 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine (Lu AA21004) | Arm Label: Duloxetine: 60 mg; Type: OTHER; Interventions: Drug: Duloxetine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Vortioxetine (Lu AA21004); Assigned to Arm(s): Vortioxetine: 2.5 mg | Intervention Type: DRUG; Name: Vortioxetine (Lu AA21004); Assigned to Arm(s): Vortioxetine: 5 mg | Intervention Type: DRUG; Name: Vortioxetine (Lu AA21004); Assigned to Arm(s): Vortioxetine: 10 mg | Intervention Type: DRUG; Name: Duloxetine; Assigned to Arm(s): Duloxetine: 60 mg
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Vortioxetine 10 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine | Arm Label: Vortioxetine 20 mg; Type: EXPERIMENTAL; Interventions: Drug: Vortioxetine | Intervention Type: DRUG; Name: Vortioxetine; Assigned to Arm(s): Vortioxetine 10 mg, Vortioxetine 20 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Brief Summary: This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Options:
A: Arm Label: Open Label Infliximab + Methotrexate; Type: EXPERIMENTAL; Interventions: Biological: Infliximab + methotrexate (MTX) | Intervention Type: BIOLOGICAL; Name: Infliximab + methotrexate (MTX); Assigned to Arm(s): Open Label Infliximab + Methotrexate
B: Arm Label: Methotrexate; Type: ACTIVE_COMPARATOR; Interventions: Biological: tocilizumab, Drug: methotrexate, Biological: 23-Valent Pneumococcal Polysaccharide Vaccine, Biological: Tetanus Toxoid Adsorbed Vaccine | Arm Label: Tocilizumab + Methotrexate; Type: EXPERIMENTAL; Interventions: Biological: tocilizumab, Drug: methotrexate, Biological: 23-Valent Pneumococcal Polysaccharide Vaccine, Biological: Tetanus Toxoid Adsorbed Vaccine | Intervention Type: BIOLOGICAL; Name: tocilizumab; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: BIOLOGICAL; Name: 23-Valent Pneumococcal Polysaccharide Vaccine; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: BIOLOGICAL; Name: Tetanus Toxoid Adsorbed Vaccine; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate
C: Arm Label: Open-Label Active Treatment Enrolled from Phase 2; Type: EXPERIMENTAL; Interventions: Drug: CP-690,550 | Arm Label: Open-Label Active Treatment Enrolled from Phase 3; Type: EXPERIMENTAL; Interventions: Drug: CP-690,550 | Intervention Type: DRUG; Name: CP-690,550; Assigned to Arm(s): Open-Label Active Treatment Enrolled from Phase 2 | Intervention Type: DRUG; Name: CP-690,550; Assigned to Arm(s): Open-Label Active Treatment Enrolled from Phase 3
D: Arm Label: CP-690,550 + methotrexate; Type: EXPERIMENTAL; Interventions: Drug: CP-690,550 + methotrexate | Arm Label: Placebo + methotrexate; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo + Methotrexate | Intervention Type: DRUG; Name: CP-690,550 + methotrexate; Assigned to Arm(s): CP-690,550 + methotrexate | Intervention Type: DRUG; Name: Placebo + Methotrexate; Assigned to Arm(s): Placebo + methotrexate

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Brief Summary: This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Options:
A: Arm Label: Methotrexate; Type: ACTIVE_COMPARATOR; Interventions: Biological: tocilizumab, Drug: methotrexate, Biological: 23-Valent Pneumococcal Polysaccharide Vaccine, Biological: Tetanus Toxoid Adsorbed Vaccine | Arm Label: Tocilizumab + Methotrexate; Type: EXPERIMENTAL; Interventions: Biological: tocilizumab, Drug: methotrexate, Biological: 23-Valent Pneumococcal Polysaccharide Vaccine, Biological: Tetanus Toxoid Adsorbed Vaccine | Intervention Type: BIOLOGICAL; Name: tocilizumab; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: BIOLOGICAL; Name: 23-Valent Pneumococcal Polysaccharide Vaccine; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate | Intervention Type: BIOLOGICAL; Name: Tetanus Toxoid Adsorbed Vaccine; Assigned to Arm(s): Methotrexate, Tocilizumab + Methotrexate
B: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: MLTA3698A, Drug: leflunomide, Drug: methotrexate | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: adalimumab, Drug: leflunomide, Drug: methotrexate, Drug: placebo | Arm Label: C; Type: PLACEBO_COMPARATOR; Interventions: Drug: leflunomide, Drug: methotrexate, Drug: placebo | Intervention Type: DRUG; Name: MLTA3698A; Assigned to Arm(s): A | Intervention Type: DRUG; Name: adalimumab; Assigned to Arm(s): B | Intervention Type: DRUG; Name: leflunomide; Assigned to Arm(s): A, B, C | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): A, B, C | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): B, C
C: Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: Golimumab | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Drug: Golimumab | Intervention Type: DRUG; Name: Golimumab; Assigned to Arm(s): 002 | Intervention Type: DRUG; Name: Golimumab; Assigned to Arm(s): 001
D: Arm Label: Abatacept; Type: EXPERIMENTAL; Interventions: Drug: Abatacept | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Abatacept; Assigned to Arm(s): Abatacept | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
Brief Summary: The aim of this study is to investigate the change in iron metabolism in relation to malaria and helminth infections using a stable isotope technique.


Options:
A: Intervention Type: DRUG; Name: zinc sulphate dietary supplement; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: iron sulphate-folic acid dietary supplement; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: ferrous sulphate (drug); Assigned to Arm(s): N/A
C: Arm Label: Vitamin/mineral fortificant with iron; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Sprinkles® | Arm Label: Vitamin/mineral fortificant without iron; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: vitamin/mineral fortificant without iron | Intervention Type: DIETARY_SUPPLEMENT; Name: Sprinkles®; Assigned to Arm(s): Vitamin/mineral fortificant with iron | Intervention Type: DIETARY_SUPPLEMENT; Name: vitamin/mineral fortificant without iron; Assigned to Arm(s): Vitamin/mineral fortificant without iron
D: Arm Label: Symptomatic malaria infection; Type: OTHER; Interventions: Dietary Supplement: Fe-57 orally, Fe-58 intravenously | Arm Label: Asymptomatic malaria infection; Type: OTHER; Interventions: Dietary Supplement: Fe-57 orally, Fe-58 intravenously | Arm Label: Hookworm infection; Type: OTHER; Interventions: Dietary Supplement: Fe-57 orally, Fe-58 intravenously | Arm Label: Schistosoma haematobium infection; Type: OTHER; Interventions: Dietary Supplement: Fe-57 orally, Fe-58 intravenously | Intervention Type: DIETARY_SUPPLEMENT; Name: Fe-57 orally, Fe-58 intravenously; Assigned to Arm(s): Asymptomatic malaria infection, Hookworm infection, Schistosoma haematobium infection, Symptomatic malaria infection

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care
Brief Summary: The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.


Options:
A: Arm Label: WHI; Type: EXPERIMENTAL; Interventions: Behavioral: Work and Health Initiative | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Medical or Behavioral Intervention | Intervention Type: BEHAVIORAL; Name: Work and Health Initiative; Assigned to Arm(s): WHI | Intervention Type: BEHAVIORAL; Name: Usual Medical or Behavioral Intervention; Assigned to Arm(s): Usual Care
B: Arm Label: Tree Theme Method ® (TTM) intervention; Type: EXPERIMENTAL; Interventions: Other: Tree Theme Method ® (TTM) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Tree Theme Method ® (TTM); Assigned to Arm(s): Tree Theme Method ® (TTM) intervention
C: Arm Label: IPS-MA; Type: EXPERIMENTAL; Interventions: Behavioral: The IPS-MA method | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: The IPS-MA method; Assigned to Arm(s): IPS-MA
D: Arm Label: Brexipiprazole + ADT; Type: EXPERIMENTAL; Interventions: Drug: OPC-34712, Drug: Placebo, Drug: ADT | Arm Label: Placebo + ADT; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: ADT | Intervention Type: DRUG; Name: OPC-34712; Assigned to Arm(s): Brexipiprazole + ADT | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Brexipiprazole + ADT, Placebo + ADT | Intervention Type: DRUG; Name: ADT; Assigned to Arm(s): Brexipiprazole + ADT, Placebo + ADT

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Arm Label: HIGH NICOTINE; Type: N/A; Interventions: N/A
B: Arm Label: Ecig 24 mg nicotine; Type: EXPERIMENTAL; Interventions: Device: Ecig 24 mg nicotine | Arm Label: Ecig 0 mg nicotine; Type: SHAM_COMPARATOR; Interventions: Device: Ecig 0 mg nicotine | Arm Label: Nicotine free inhalator; Type: PLACEBO_COMPARATOR; Interventions: Device: Nicotine free inhalator | Intervention Type: DEVICE; Name: Ecig 24 mg nicotine; Assigned to Arm(s): Ecig 24 mg nicotine | Intervention Type: DEVICE; Name: Ecig 0 mg nicotine; Assigned to Arm(s): Ecig 0 mg nicotine | Intervention Type: DEVICE; Name: Nicotine free inhalator; Assigned to Arm(s): Nicotine free inhalator
C: Arm Label: CO reminder; Type: EXPERIMENTAL; Interventions: Behavioral: Informing surgical patients about CO monitoring | Arm Label: no CO reminder; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: a brief intervention recommending preoperative abstinence from smoking | Intervention Type: BEHAVIORAL; Name: Informing surgical patients about CO monitoring; Assigned to Arm(s): CO reminder | Intervention Type: BEHAVIORAL; Name: a brief intervention recommending preoperative abstinence from smoking; Assigned to Arm(s): no CO reminder
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Swedish snus (smokeless tobacco) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Other: Onico | Intervention Type: OTHER; Name: Swedish snus (smokeless tobacco); Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Onico; Assigned to Arm(s): 2

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Arm Label: HIGH NICOTINE; Type: N/A; Interventions: N/A
B: Arm Label: Arm I (varenicline); Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: Arm II (nicotine patch); Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine patch | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): Arm I (varenicline) | Intervention Type: DRUG; Name: nicotine patch; Assigned to Arm(s): Arm II (nicotine patch)
C: Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): N/A
D: Arm Label: Electronic cigarettes; Type: EXPERIMENTAL; Interventions: Other: disposable electronic cigarettes | Intervention Type: OTHER; Name: disposable electronic cigarettes; Assigned to Arm(s): Electronic cigarettes

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Arm Label: E-cigarettes only; Type: N/A; Interventions: N/A | Arm Label: Traditional cigarettes only; Type: N/A; Interventions: N/A | Arm Label: Mixed group; Type: N/A; Interventions: N/A
B: Arm Label: cigarette substitute; Type: EXPERIMENTAL; Interventions: Other: cigarette substitute | Arm Label: e-cigarette (with 0 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 8 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 36 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Intervention Type: OTHER; Name: e-cigarette; Assigned to Arm(s): e-cigarette (with 0 mg/ml nicotine), e-cigarette (with 36 mg/ml nicotine), e-cigarette (with 8 mg/ml nicotine) | Intervention Type: OTHER; Name: cigarette substitute; Assigned to Arm(s): cigarette substitute
C: Arm Label: Nicotine-inclusive e-cigarettes; Type: EXPERIMENTAL; Interventions: Other: Electronic Cigarette and behavioural change support. | Arm Label: Nicotine-free e-cigarettes; Type: EXPERIMENTAL; Interventions: Other: Nicotine-Free Electronic Cigarette and behavioural change support. | Arm Label: Nicotine Replacement Therapy (NRT); Type: ACTIVE_COMPARATOR; Interventions: Other: Nicotine Replacement Therapy and behavioural change support. | Intervention Type: OTHER; Name: Electronic Cigarette and behavioural change support.; Assigned to Arm(s): Nicotine-inclusive e-cigarettes | Intervention Type: OTHER; Name: Nicotine-Free Electronic Cigarette and behavioural change support.; Assigned to Arm(s): Nicotine-free e-cigarettes | Intervention Type: OTHER; Name: Nicotine Replacement Therapy and behavioural change support.; Assigned to Arm(s): Nicotine Replacement Therapy (NRT)
D: Arm Label: HIGH NICOTINE; Type: N/A; Interventions: N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Arm Label: EGO/CE4, 9mg nicotine; Type: OTHER; Interventions: Device: EGO/CE4, 9mg nicotine | Intervention Type: DEVICE; Name: EGO/CE4, 9mg nicotine; Assigned to Arm(s): EGO/CE4, 9mg nicotine
B: Arm Label: cigarette substitute; Type: EXPERIMENTAL; Interventions: Other: cigarette substitute | Arm Label: e-cigarette (with 0 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 8 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 36 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Intervention Type: OTHER; Name: e-cigarette; Assigned to Arm(s): e-cigarette (with 0 mg/ml nicotine), e-cigarette (with 36 mg/ml nicotine), e-cigarette (with 8 mg/ml nicotine) | Intervention Type: OTHER; Name: cigarette substitute; Assigned to Arm(s): cigarette substitute
C: Arm Label: E-Cigarette 7.2 mg nicotine; Type: EXPERIMENTAL; Interventions: Device: E-Cigarette 7.2 mg nicotine | Intervention Type: DEVICE; Name: E-Cigarette 7.2 mg nicotine; Assigned to Arm(s): E-Cigarette 7.2 mg nicotine
D: Arm Label: HIGH NICOTINE; Type: N/A; Interventions: N/A

Answer: D