TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Brief Summary: 1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls.


Options:
A: Arm Label: Early treatment; Type: EXPERIMENTAL; Interventions: Other: comprehensive dental treatment | Arm Label: Regualr treatment; Type: NO_INTERVENTION; Interventions: Other: Only emergency dental treatment | Intervention Type: OTHER; Name: comprehensive dental treatment; Assigned to Arm(s): Early treatment | Intervention Type: OTHER; Name: Only emergency dental treatment; Assigned to Arm(s): Regualr treatment
B: Intervention Type: DRUG; Name: Fluoride varnish; Assigned to Arm(s): N/A
C: Intervention Type: BEHAVIORAL; Name: Nutritional and life style counseling; Assigned to Arm(s): N/A
D: Arm Label: I, Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary Advice | Arm Label: II, Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary Advice; Assigned to Arm(s): I, Intervention

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: VA Low Vision Intervention Trial
Brief Summary: The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.


Options:
A: Arm Label: regular O&M-training; Type: ACTIVE_COMPARATOR; Interventions: Other: orientation and mobility training | Arm Label: standardised O&M-training; Type: EXPERIMENTAL; Interventions: Other: orientation and mobility training | Intervention Type: OTHER; Name: orientation and mobility training; Assigned to Arm(s): regular O&M-training, standardised O&M-training
B: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Other: Low Vision Intervention - Outpatient Training Program | Arm Label: Arm 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Low Vision Intervention - Outpatient Training Program; Assigned to Arm(s): Arm 1
C: Arm Label: Yoga Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Yoga Intervention | Intervention Type: BEHAVIORAL; Name: Yoga Intervention; Assigned to Arm(s): Yoga Therapy
D: Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual care | Arm Label: Overground visual cue training; Type: EXPERIMENTAL; Interventions: Behavioral: Overground visual cue training | Arm Label: Treadmill visual cue training; Type: EXPERIMENTAL; Interventions: Behavioral: Treadmill visual cue training | Intervention Type: BEHAVIORAL; Name: Usual care; Assigned to Arm(s): Usual Care | Intervention Type: BEHAVIORAL; Name: Overground visual cue training; Assigned to Arm(s): Overground visual cue training | Intervention Type: BEHAVIORAL; Name: Treadmill visual cue training; Assigned to Arm(s): Treadmill visual cue training

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: VA Low Vision Intervention Trial
Brief Summary: The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.


Options:
A: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Other: Low Vision Intervention - Outpatient Training Program | Arm Label: Arm 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Low Vision Intervention - Outpatient Training Program; Assigned to Arm(s): Arm 1
B: Arm Label: Ranibizumab 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: Ranibizumab, Procedure: Laser, Procedure: Sham laser | Arm Label: Ranibizumab 0.5 mg + laser; Type: EXPERIMENTAL; Interventions: Drug: Ranibizumab, Procedure: Laser | Arm Label: Laser; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ranibizumab, Procedure: Laser, Drug: Sham to ranibizumab | Intervention Type: DRUG; Name: Ranibizumab; Assigned to Arm(s): Laser, Ranibizumab 0.5 mg, Ranibizumab 0.5 mg + laser | Intervention Type: PROCEDURE; Name: Laser; Assigned to Arm(s): Laser, Ranibizumab 0.5 mg, Ranibizumab 0.5 mg + laser | Intervention Type: PROCEDURE; Name: Sham laser; Assigned to Arm(s): Ranibizumab 0.5 mg | Intervention Type: DRUG; Name: Sham to ranibizumab; Assigned to Arm(s): Laser
C: Arm Label: Ranibizumab 0.3 mg; Type: EXPERIMENTAL; Interventions: Drug: Ranibizumab | Arm Label: Ranibizumab 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: Ranibizumab | Arm Label: Sham injection/ranibizumab 0.5 mg; Type: SHAM_COMPARATOR; Interventions: Drug: Sham injection | Intervention Type: DRUG; Name: Ranibizumab; Assigned to Arm(s): Ranibizumab 0.3 mg, Ranibizumab 0.5 mg | Intervention Type: DRUG; Name: Sham injection; Assigned to Arm(s): Sham injection/ranibizumab 0.5 mg
D: Intervention Type: PROCEDURE; Name: Eccentric Viewing Training for Reading; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Arm Label: ArmAssist therapy; Type: EXPERIMENTAL; Interventions: Device: ArmAssist robotic training, Other: Conventional therapy | Arm Label: Conventional therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional therapy | Arm Label: Extended Conventional therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional therapy, Other: Extended conventional therapy | Intervention Type: DEVICE; Name: ArmAssist robotic training; Assigned to Arm(s): ArmAssist therapy | Intervention Type: OTHER; Name: Conventional therapy; Assigned to Arm(s): ArmAssist therapy, Conventional therapy, Extended Conventional therapy | Intervention Type: OTHER; Name: Extended conventional therapy; Assigned to Arm(s): Extended Conventional therapy
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: robot therapy (ARMin) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: conventional therapy | Intervention Type: DEVICE; Name: robot therapy (ARMin); Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: conventional therapy; Assigned to Arm(s): 2
C: Arm Label: Robot-Low; Type: EXPERIMENTAL; Interventions: Other: Robot-Low | Arm Label: Robot-High; Type: EXPERIMENTAL; Interventions: Other: Robot-High | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: Robot-Low; Assigned to Arm(s): Robot-Low | Intervention Type: OTHER; Name: Robot-High; Assigned to Arm(s): Robot-High | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control
D: Intervention Type: DEVICE; Name: robotic device; Assigned to Arm(s): N/A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Arm Label: Intensive Walking; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive Walking | Arm Label: Conventional Physical Therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Conventional Physical Therapy | Intervention Type: BEHAVIORAL; Name: Intensive Walking; Assigned to Arm(s): Intensive Walking | Intervention Type: BEHAVIORAL; Name: Conventional Physical Therapy; Assigned to Arm(s): Conventional Physical Therapy
B: Arm Label: High Therapy Dose; Type: EXPERIMENTAL; Interventions: Behavioral: Accelerated Skill Acquisition Program (ASAP) | Arm Label: Moderate Therapy Dose; Type: EXPERIMENTAL; Interventions: Behavioral: Accelerated Skill Acquisition Program (ASAP) | Arm Label: Low Therapy Dose; Type: EXPERIMENTAL; Interventions: Behavioral: Accelerated Skill Acquisition Program (ASAP) | Arm Label: Active Monitoring; Type: OTHER; Interventions: Behavioral: Active Monitoring | Intervention Type: BEHAVIORAL; Name: Accelerated Skill Acquisition Program (ASAP); Assigned to Arm(s): High Therapy Dose, Low Therapy Dose, Moderate Therapy Dose | Intervention Type: BEHAVIORAL; Name: Active Monitoring; Assigned to Arm(s): Active Monitoring
C: Arm Label: Robot-Low; Type: EXPERIMENTAL; Interventions: Other: Robot-Low | Arm Label: Robot-High; Type: EXPERIMENTAL; Interventions: Other: Robot-High | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: Robot-Low; Assigned to Arm(s): Robot-Low | Intervention Type: OTHER; Name: Robot-High; Assigned to Arm(s): Robot-High | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control
D: Arm Label: usual management; Type: OTHER; Interventions: Other: no physical activity | Arm Label: physical training; Type: EXPERIMENTAL; Interventions: Other: physical activity | Intervention Type: OTHER; Name: no physical activity; Assigned to Arm(s): usual management | Intervention Type: OTHER; Name: physical activity; Assigned to Arm(s): physical training

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Arm Label: Traditional physiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Traditional physiotherapy | Arm Label: Robot Group; Type: EXPERIMENTAL; Interventions: Device: Robot Group | Intervention Type: DEVICE; Name: Robot Group; Assigned to Arm(s): Robot Group | Intervention Type: PROCEDURE; Name: Traditional physiotherapy; Assigned to Arm(s): Traditional physiotherapy
B: Arm Label: Robot-Low; Type: EXPERIMENTAL; Interventions: Other: Robot-Low | Arm Label: Robot-High; Type: EXPERIMENTAL; Interventions: Other: Robot-High | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: Robot-Low; Assigned to Arm(s): Robot-Low | Intervention Type: OTHER; Name: Robot-High; Assigned to Arm(s): Robot-High | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: robot therapy (ARMin) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: conventional therapy | Intervention Type: DEVICE; Name: robot therapy (ARMin); Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: conventional therapy; Assigned to Arm(s): 2
D: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Device: Robotic Upper Extremity Neurorehabilitation | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Traditional Upper Extremity Exercise Group | Intervention Type: DEVICE; Name: Robotic Upper Extremity Neurorehabilitation; Assigned to Arm(s): Arm 1 | Intervention Type: OTHER; Name: Traditional Upper Extremity Exercise Group; Assigned to Arm(s): Arm 2

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Enhancing Conservative Treatment for Urge Incontinence
Brief Summary: The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Solifenacin succinate | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Simplified bladder training | Intervention Type: DRUG; Name: Solifenacin succinate; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Simplified bladder training; Assigned to Arm(s): 2
B: Arm Label: Group 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Structured training and leaflet | Arm Label: Group 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Structured training | Arm Label: Group 3; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Leaflet | Arm Label: Group 4; Type: SHAM_COMPARATOR; Interventions: Behavioral: Control Group | Intervention Type: BEHAVIORAL; Name: Structured training and leaflet; Assigned to Arm(s): Group 1 | Intervention Type: BEHAVIORAL; Name: Structured training; Assigned to Arm(s): Group 2 | Intervention Type: BEHAVIORAL; Name: Leaflet; Assigned to Arm(s): Group 3 | Intervention Type: BEHAVIORAL; Name: Control Group; Assigned to Arm(s): Group 4
C: Arm Label: Drug Therapy Aone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxybutynin chloride, extended-release, individually-titrated | Arm Label: Drug Therapy + Behavioral Training; Type: EXPERIMENTAL; Interventions: Drug: Oxybutynin chloride, extended-release, individually-titrated, Behavioral: Behavior Training | Intervention Type: DRUG; Name: Oxybutynin chloride, extended-release, individually-titrated; Assigned to Arm(s): Drug Therapy + Behavioral Training, Drug Therapy Aone | Intervention Type: BEHAVIORAL; Name: Behavior Training; Assigned to Arm(s): Drug Therapy + Behavioral Training
D: Arm Label: Anticholinergic medications; Type: ACTIVE_COMPARATOR; Interventions: Drug: Anticholinergic medications | Arm Label: Hypnotherapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Hypnotherapy | Intervention Type: DRUG; Name: Anticholinergic medications; Assigned to Arm(s): Anticholinergic medications | Intervention Type: BEHAVIORAL; Name: Hypnotherapy; Assigned to Arm(s): Hypnotherapy

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Enhancing Conservative Treatment for Urge Incontinence
Brief Summary: The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: tolterodine | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: bladder training | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Procedure: pelvic floor muscle training | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Procedure: pelvic floor rehabilitation | Intervention Type: PROCEDURE; Name: tolterodine; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: bladder training; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: pelvic floor muscle training; Assigned to Arm(s): 3 | Intervention Type: PROCEDURE; Name: pelvic floor rehabilitation; Assigned to Arm(s): 4
B: Arm Label: Exercise training; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise training
C: Arm Label: Tät®II Treatment app; Type: EXPERIMENTAL; Interventions: Device: Tät®II Treatment app | Arm Label: Tät®II Information app; Type: OTHER; Interventions: Device: Tät®II Information app | Intervention Type: DEVICE; Name: Tät®II Information app; Assigned to Arm(s): Tät®II Information app | Intervention Type: DEVICE; Name: Tät®II Treatment app; Assigned to Arm(s): Tät®II Treatment app
D: Arm Label: Drug Therapy Aone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxybutynin chloride, extended-release, individually-titrated | Arm Label: Drug Therapy + Behavioral Training; Type: EXPERIMENTAL; Interventions: Drug: Oxybutynin chloride, extended-release, individually-titrated, Behavioral: Behavior Training | Intervention Type: DRUG; Name: Oxybutynin chloride, extended-release, individually-titrated; Assigned to Arm(s): Drug Therapy + Behavioral Training, Drug Therapy Aone | Intervention Type: BEHAVIORAL; Name: Behavior Training; Assigned to Arm(s): Drug Therapy + Behavioral Training

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.


Options:
A: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: Tamsulosin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tamsulosin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: DRUG; Name: Tamsulosin; Assigned to Arm(s): Tamsulosin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo tablet, Drug: Placebo capsule | Arm Label: Tadalafil 5 milligram (mg); Type: EXPERIMENTAL; Interventions: Drug: Tadalafil 5 mg | Arm Label: Tamsulosin 0.4 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tamsulosin | Intervention Type: DRUG; Name: Tadalafil 5 mg; Assigned to Arm(s): Tadalafil 5 milligram (mg) | Intervention Type: DRUG; Name: Placebo tablet; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tamsulosin; Assigned to Arm(s): Tamsulosin 0.4 mg | Intervention Type: DRUG; Name: Placebo capsule; Assigned to Arm(s): Placebo

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.


Options:
A: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: Tamsulosin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tamsulosin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: DRUG; Name: Tamsulosin; Assigned to Arm(s): Tamsulosin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo tablet, Drug: Placebo capsule | Arm Label: Tadalafil 5 milligram (mg); Type: EXPERIMENTAL; Interventions: Drug: Tadalafil 5 mg | Arm Label: Tamsulosin 0.4 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tamsulosin | Intervention Type: DRUG; Name: Tadalafil 5 mg; Assigned to Arm(s): Tadalafil 5 milligram (mg) | Intervention Type: DRUG; Name: Placebo tablet; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tamsulosin; Assigned to Arm(s): Tamsulosin 0.4 mg | Intervention Type: DRUG; Name: Placebo capsule; Assigned to Arm(s): Placebo
D: Arm Label: Silodosin; Type: EXPERIMENTAL; Interventions: Drug: Silodosin | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Silodosin; Assigned to Arm(s): Silodosin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Arm Label: 1 - CBT Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Motivational interviewing for smoking cessation, Behavioral: Cognitive behaviors therapy | Arm Label: 2 - Counseling + NRT; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational interviewing for smoking cessation, Drug: CBT + NRT | Intervention Type: BEHAVIORAL; Name: Motivational interviewing for smoking cessation; Assigned to Arm(s): 1 - CBT Counseling, 2 - Counseling + NRT | Intervention Type: BEHAVIORAL; Name: Cognitive behaviors therapy; Assigned to Arm(s): 1 - CBT Counseling | Intervention Type: DRUG; Name: CBT + NRT; Assigned to Arm(s): 2 - Counseling + NRT
B: Arm Label: A; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: 2 mg nicotine polacrilex | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): A | Intervention Type: DRUG; Name: 2 mg nicotine polacrilex; Assigned to Arm(s): B
C: Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A

Answer: A