TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Options:
A: Intervention Type: PROCEDURE; Name: Supplementation with fish oil versus placebo; Assigned to Arm(s): N/A
B: Arm Label: N-3 PUFA; Type: EXPERIMENTAL; Interventions: Drug: N-3 Polyunsaturated Fatty Acids | Arm Label: Olive oil; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo: Olive oil | Intervention Type: DRUG; Name: N-3 Polyunsaturated Fatty Acids; Assigned to Arm(s): N-3 PUFA | Intervention Type: DRUG; Name: Placebo: Olive oil; Assigned to Arm(s): Olive oil
C: Arm Label: Trevo Thrombectomy Procedure; Type: EXPERIMENTAL; Interventions: Device: Trevo Thrombectomy Procedure, Other: Medical Management | Arm Label: Medical Management; Type: ACTIVE_COMPARATOR; Interventions: Other: Medical Management | Intervention Type: DEVICE; Name: Trevo Thrombectomy Procedure; Assigned to Arm(s): Trevo Thrombectomy Procedure | Intervention Type: OTHER; Name: Medical Management; Assigned to Arm(s): Medical Management, Trevo Thrombectomy Procedure
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | 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: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Intervention Type: BEHAVIORAL; Name: Smoking Relapse Prevention; Assigned to Arm(s): N/A
B: Arm Label: Ban & Informational Pamphlet; Type: EXPERIMENTAL; Interventions: Behavioral: Tobacco Use Ban, Behavioral: Informational Pamphlet | Arm Label: Ban & Tailored Pamphlet; Type: EXPERIMENTAL; Interventions: Behavioral: Tobacco Use Ban, Behavioral: Tailored Pamphlet | Arm Label: Ban & Tailored Pamphlet & Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Tobacco Use Ban, Behavioral: Tailored Pamphlet, Behavioral: Relapse Prevention Intervention | Intervention Type: BEHAVIORAL; Name: Tobacco Use Ban; Assigned to Arm(s): Ban & Informational Pamphlet, Ban & Tailored Pamphlet, Ban & Tailored Pamphlet & Intervention | Intervention Type: BEHAVIORAL; Name: Tailored Pamphlet; Assigned to Arm(s): Ban & Tailored Pamphlet, Ban & Tailored Pamphlet & Intervention | Intervention Type: BEHAVIORAL; Name: Informational Pamphlet; Assigned to Arm(s): Ban & Informational Pamphlet | Intervention Type: BEHAVIORAL; Name: Relapse Prevention Intervention; Assigned to Arm(s): Ban & Tailored Pamphlet & Intervention
C: Arm Label: 8 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 24 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 52 weeks transdermal nicotine; Type: EXPERIMENTAL; Interventions: Drug: Transdermal nicotine patch | Intervention Type: DRUG; Name: Transdermal nicotine patch; Assigned to Arm(s): 24 weeks transdermal nicotine, 52 weeks transdermal nicotine, 8 weeks transdermal nicotine
D: Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Arm Label: Receiving WhatsApp messages; Type: EXPERIMENTAL; Interventions: Behavioral: WhatsApp embedded in smoking cessation service | Arm Label: Not receiving WhatsApp messages; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: WhatsApp embedded in smoking cessation service; Assigned to Arm(s): Receiving WhatsApp messages
B: Arm Label: Longitudinal Care; Type: EXPERIMENTAL; Interventions: Behavioral: smoking cessation | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: smoking cessation | Intervention Type: BEHAVIORAL; Name: smoking cessation; Assigned to Arm(s): Longitudinal Care, Usual Care
C: Arm Label: 8 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 24 weeks transdermal nicotine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch | Arm Label: 52 weeks transdermal nicotine; Type: EXPERIMENTAL; Interventions: Drug: Transdermal nicotine patch | Intervention Type: DRUG; Name: Transdermal nicotine patch; Assigned to Arm(s): 24 weeks transdermal nicotine, 52 weeks transdermal nicotine, 8 weeks transdermal nicotine
D: Arm Label: WhatsApp; Type: EXPERIMENTAL; Interventions: Behavioral: WhatsApp | Arm Label: Facebook; Type: EXPERIMENTAL; Interventions: Behavioral: Facebook | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: WhatsApp; Assigned to Arm(s): WhatsApp | Intervention Type: BEHAVIORAL; Name: Facebook; Assigned to Arm(s): Facebook

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.


Options:
A: Arm Label: EPA + DHA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: ALA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: EPA + DHA plus ALA; Type: EXPERIMENTAL; Interventions: Dietary Supplement: margarine spread | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: margarine spread | Intervention Type: DIETARY_SUPPLEMENT; Name: margarine spread; Assigned to Arm(s): ALA, EPA + DHA, EPA + DHA plus ALA, Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Pikasol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pikasol | Arm Label: Corn oil; Type: PLACEBO_COMPARATOR; Interventions: Other: Corn oil | Intervention Type: DRUG; Name: Pikasol; Assigned to Arm(s): Pikasol | Intervention Type: OTHER; Name: Corn oil; Assigned to Arm(s): Corn oil
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Omega 3 (n-3 PUFA) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega 3 (n-3 PUFA); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: n-3 PUFA | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: n-3 PUFA; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Trevo Thrombectomy Procedure; Type: EXPERIMENTAL; Interventions: Device: Trevo Thrombectomy Procedure, Other: Medical Management | Arm Label: Medical Management; Type: ACTIVE_COMPARATOR; Interventions: Other: Medical Management | Intervention Type: DEVICE; Name: Trevo Thrombectomy Procedure; Assigned to Arm(s): Trevo Thrombectomy Procedure | Intervention Type: OTHER; Name: Medical Management; Assigned to Arm(s): Medical Management, Trevo Thrombectomy Procedure
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Arm Label: vargatef/Nintedanib; Type: EXPERIMENTAL; Interventions: Drug: vargatef | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: vargatef; Assigned to Arm(s): vargatef/Nintedanib | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
B: Arm Label: 1/OLAPARIB; Type: EXPERIMENTAL; Interventions: Drug: OLAPARIB | Arm Label: 2/CHEMOTHERAPY; Type: ACTIVE_COMPARATOR; Interventions: Drug: Single agent chemotherapy | Intervention Type: DRUG; Name: OLAPARIB; Assigned to Arm(s): 1/OLAPARIB | Intervention Type: DRUG; Name: Single agent chemotherapy; Assigned to Arm(s): 2/CHEMOTHERAPY
C: Arm Label: Tivozanib; Type: EXPERIMENTAL; Interventions: Drug: Tivozanib | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Tivozanib; Assigned to Arm(s): Tivozanib
D: Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): Experimental

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): Experimental
B: Arm Label: PLD; Type: ACTIVE_COMPARATOR; Interventions: Drug: PLD 40mg/m2 ivgtt q4w | Arm Label: PLD + Apatinib; Type: EXPERIMENTAL; Interventions: Drug: PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd | Intervention Type: DRUG; Name: PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd; Assigned to Arm(s): PLD + Apatinib | Intervention Type: DRUG; Name: PLD 40mg/m2 ivgtt q4w; Assigned to Arm(s): PLD
C: Arm Label: Rucaparib; Type: EXPERIMENTAL; Interventions: Drug: Rucaparib | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rucaparib; Assigned to Arm(s): Rucaparib | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Carboplatin and gemcitabine + bevacizumab; Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Gemcitabine, Drug: Bevacizumab | Arm Label: Carboplatin and gemcitabine + placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Gemcitabine, Drug: Placebo | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Carboplatin and gemcitabine + bevacizumab, Carboplatin and gemcitabine + placebo | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Carboplatin and gemcitabine + bevacizumab, Carboplatin and gemcitabine + placebo | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Carboplatin and gemcitabine + bevacizumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Carboplatin and gemcitabine + placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Brief Summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Options:
A: Arm Label: myo-inositol; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: myo-inositol | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: folic acid 400 mcg | Intervention Type: DIETARY_SUPPLEMENT; Name: myo-inositol; Assigned to Arm(s): myo-inositol | Intervention Type: OTHER; Name: folic acid 400 mcg; Assigned to Arm(s): placebo
B: Arm Label: Nutritional counseling & self blood glucose monitoring; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: nutritional counseling, Behavioral: self blood glucose monitoring | Arm Label: No treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: nutritional counseling; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring | Intervention Type: BEHAVIORAL; Name: self blood glucose monitoring; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring
C: Arm Label: Glyburide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Glyburide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Glyburide; Assigned to Arm(s): Glyburide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Low CHO; Type: EXPERIMENTAL; Interventions: Behavioral: Low CHO | Arm Label: High CHO; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: High CHO diet | Intervention Type: BEHAVIORAL; Name: Low CHO; Assigned to Arm(s): Low CHO | Intervention Type: DIETARY_SUPPLEMENT; Name: High CHO diet; Assigned to Arm(s): High CHO

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Brief Summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Options:
A: Arm Label: Myo-inositol powder; Type: EXPERIMENTAL; Interventions: Dietary Supplement: inositol + folic acid | Arm Label: Myo-inositol soft gel capsules; Type: EXPERIMENTAL; Interventions: Dietary Supplement: inositol + folic acid | Arm Label: Folic acid; Type: PLACEBO_COMPARATOR; Interventions: Drug: Folic Acid | Intervention Type: DIETARY_SUPPLEMENT; Name: inositol + folic acid; Assigned to Arm(s): Myo-inositol powder | Intervention Type: DIETARY_SUPPLEMENT; Name: inositol + folic acid; Assigned to Arm(s): Myo-inositol soft gel capsules | Intervention Type: DRUG; Name: Folic Acid; Assigned to Arm(s): Folic acid
B: Arm Label: Usual Care; Type: OTHER; Interventions: Other: Usual Care | Arm Label: Weight Management Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Weight Management | Intervention Type: BEHAVIORAL; Name: Weight Management; Assigned to Arm(s): Weight Management Counseling | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
C: Arm Label: Intensive Counseling Group; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary and lifestyle counseling | Arm Label: Routine care group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary and lifestyle counseling; Assigned to Arm(s): Intensive Counseling Group
D: Arm Label: myo-inositol; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: myo-inositol | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: folic acid 400 mcg | Intervention Type: DIETARY_SUPPLEMENT; Name: myo-inositol; Assigned to Arm(s): myo-inositol | Intervention Type: OTHER; Name: folic acid 400 mcg; Assigned to Arm(s): placebo

Answer: D