TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
Brief Summary: The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.


Options:
A: Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): N/A
B: Arm Label: fluticasone furoate/vilanterol; Type: EXPERIMENTAL; Interventions: Drug: fluticasone furoate/vilanterol | Arm Label: fluticasone furoate; Type: EXPERIMENTAL; Interventions: Drug: fluticasone furoate | Arm Label: vilanterol; Type: EXPERIMENTAL; Interventions: Drug: vilanterol | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: fluticasone furoate/vilanterol; Assigned to Arm(s): fluticasone furoate/vilanterol | Intervention Type: DRUG; Name: fluticasone furoate; Assigned to Arm(s): fluticasone furoate | Intervention Type: DRUG; Name: vilanterol; Assigned to Arm(s): vilanterol | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: Tiotropium Respimat 5mcg (Tio R5); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Tiotropium Respimat 10mcg (Tio R10); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Placebo; Type: OTHER; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Tiotropium Inhalation Solution; Assigned to Arm(s): Tiotropium Respimat 10mcg (Tio R10), Tiotropium Respimat 5mcg (Tio R5) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Intervention Type: DRUG; Name: Budesonide/formoterol pMDI; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Budesonide pMDI; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Formoterol Turbuhaler; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
Brief Summary: The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.


Options:
A: Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): N/A
B: Intervention Type: DEVICE; Name: Pulmonary function Testing; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: Tiotropium (Spiriva®); Assigned to Arm(s): N/A
D: Arm Label: Tiotropium Respimat 5mcg (Tio R5); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Tiotropium Respimat 10mcg (Tio R10); Type: OTHER; Interventions: Drug: Tiotropium Inhalation Solution | Arm Label: Placebo; Type: OTHER; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Tiotropium Inhalation Solution; Assigned to Arm(s): Tiotropium Respimat 10mcg (Tio R10), Tiotropium Respimat 5mcg (Tio R5) | 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: A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.


Options:
A: Arm Label: MF/F MDI 400/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF/F MDI 200/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF MDI 400 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate MDI (MF MDI) | Arm Label: Formoterol MDI 10 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol MDI | Arm Label: Placebo MDI BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 400/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 200/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate MDI (MF MDI); Assigned to Arm(s): MF MDI 400 mcg BID | Intervention Type: DRUG; Name: Formoterol MDI; Assigned to Arm(s): Formoterol MDI 10 mcg BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo MDI BID
B: Arm Label: F 4.5 bid; Type: EXPERIMENTAL; Interventions: Drug: Formoterol Turbuhaler® 4.5mg | Arm Label: F 9.0 bid; Type: EXPERIMENTAL; Interventions: Drug: Formoterol Turbuhaler® 9 mg | Arm Label: PBO; Type: PLACEBO_COMPARATOR; Interventions: Drug: Turbuhaler® placebo | Intervention Type: DRUG; Name: Formoterol Turbuhaler® 4.5mg; Assigned to Arm(s): F 4.5 bid | Intervention Type: DRUG; Name: Formoterol Turbuhaler® 9 mg; Assigned to Arm(s): F 9.0 bid | Intervention Type: DRUG; Name: Turbuhaler® placebo; Assigned to Arm(s): PBO
C: Arm Label: Tiotropium; Type: OTHER; Interventions: Drug: Tiotropium | Arm Label: Placebo; Type: OTHER; Interventions: Device: Respimat | Intervention Type: DEVICE; Name: Respimat; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium
D: Intervention Type: DEVICE; Name: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.


Options:
A: Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): N/A
B: Intervention Type: DEVICE; Name: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): N/A

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 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
Brief Summary: The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.


Options:
A: Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: ABT-335 plus rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: ABT-335 plus rosuvastatin | Arm Label: Rosuvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rosuvastatin | Intervention Type: DRUG; Name: ABT-335 plus rosuvastatin; Assigned to Arm(s): ABT-335 plus rosuvastatin | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin | Arm Label: 2; Type: SHAM_COMPARATOR; Interventions: Drug: EZE/simvastatin | Arm Label: 3; Type: SHAM_COMPARATOR; Interventions: Drug: EZE/simvastatin | Intervention Type: DRUG; Name: simvastatin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: EZE/simvastatin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: EZE/simvastatin; Assigned to Arm(s): 3
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Simvastatin 20mg plus Ezetimibe 10mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Simvastatin 20 mg, Drug: Ezetimibe 10mg | Arm Label: Simvastatin 20mg; Type: OTHER; Interventions: Drug: Simvastatin 20 mg | Intervention Type: DRUG; Name: Simvastatin 20 mg; Assigned to Arm(s): Simvastatin 20mg, Simvastatin 20mg plus Ezetimibe 10mg | Intervention Type: DRUG; Name: Ezetimibe 10mg; Assigned to Arm(s): Simvastatin 20mg plus Ezetimibe 10mg | 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: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
Brief Summary: The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.


Options:
A: Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin
B: Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Combination Therapy; Type: EXPERIMENTAL; Interventions: Drug: Extended release niacin, Drug: Simvastatin | Arm Label: Monotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Simvastatin | Intervention Type: DRUG; Name: Extended release niacin; Assigned to Arm(s): Combination Therapy | Intervention Type: DRUG; Name: Simvastatin; Assigned to Arm(s): Combination Therapy, Monotherapy
D: Arm Label: Ezetimibe/simvastatin; Type: EXPERIMENTAL; Interventions: Drug: ezetimibe (+) simvastatin, Drug: atorvastatin 10 mg or simvastatin 20 mg | Arm Label: Doubling statin dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin 40 mg or atorvastatin 20 mg, Drug: atorvastatin 10 mg or simvastatin 20 mg | Arm Label: Rosuvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rosuvastatin, Drug: atorvastatin 10 mg or simvastatin 20 mg | Intervention Type: DRUG; Name: ezetimibe (+) simvastatin; Assigned to Arm(s): Ezetimibe/simvastatin | Intervention Type: DRUG; Name: simvastatin 40 mg or atorvastatin 20 mg; Assigned to Arm(s): Doubling statin dose | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: DRUG; Name: atorvastatin 10 mg or simvastatin 20 mg; Assigned to Arm(s): Doubling statin dose, Ezetimibe/simvastatin, Rosuvastatin

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 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
Brief Summary: The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.


Options:
A: Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Intervention Type: BEHAVIORAL; Name: Diet; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Diet+pravastatin; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: simvastatin | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: simvastatin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: Rosuvastatin calcium; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein
Brief Summary: The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.


Options:
A: Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Rosuvastatin; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): Rosuvastatin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sugar pill
C: Arm Label: Atorvastatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Atorvastatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Atorvastatin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: treatment; Type: EXPERIMENTAL; Interventions: Drug: Simvastatin | Arm Label: untreated; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Simvastatin; Assigned to Arm(s): treatment

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
Brief Summary: The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.


Options:
A: Arm Label: TMNS and pelvic floor muscle training; Type: EXPERIMENTAL; Interventions: Device: Transcutaneous mechanical nerve stimulation (TMNS) | Arm Label: Pelvic floor muscle training only; Type: ACTIVE_COMPARATOR; Interventions: Other: Pelvic floor muscle training | Intervention Type: DEVICE; Name: Transcutaneous mechanical nerve stimulation (TMNS); Assigned to Arm(s): TMNS and pelvic floor muscle training | Intervention Type: OTHER; Name: Pelvic floor muscle training; Assigned to Arm(s): Pelvic floor muscle training only
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Strength training of the pelvic floor muscles, Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist | Intervention Type: BEHAVIORAL; Name: Strength training of the pelvic floor muscles; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist; Assigned to Arm(s): 1, 2
C: Arm Label: Rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: RePCa A | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: RePCa A | Intervention Type: BEHAVIORAL; Name: RePCa A; Assigned to Arm(s): Control, Rehabilitation
D: Intervention Type: BEHAVIORAL; Name: exercise intervention; Assigned to Arm(s): N/A | Intervention Type: OTHER; Name: questionnaire administration; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: biofeedback; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: management of therapy complications; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: psychosocial assessment and care; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): N/A

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Brief Summary: Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Bemiparin | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Bemiparin; Assigned to Arm(s): 1
B: Arm Label: Semuloparin; Type: EXPERIMENTAL; Interventions: Drug: Semuloparin sodium | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (for semuloparin) | Intervention Type: DRUG; Name: Semuloparin sodium; Assigned to Arm(s): Semuloparin | Intervention Type: DRUG; Name: Placebo (for semuloparin); Assigned to Arm(s): Placebo
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Intervention Type: DRUG; Name: dalteparin; Assigned to Arm(s): A, B, C
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lenalidomide, Drug: Prednisone, Drug: Melphalan | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Melphalan | Intervention Type: DRUG; Name: Melphalan; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Lenalidomide; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Melphalan; Assigned to Arm(s): A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Brief Summary: Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.


Options:
A: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin | Intervention Type: DRUG; Name: dalteparin; Assigned to Arm(s): A, B, C
B: Arm Label: Cohort 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 1: Apixaban, 5 mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: Apixaban | Arm Label: Cohort 1: Apixaban, 10 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Apixaban | Arm Label: Cohort 1: Apixaban, 20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Apixaban | Arm Label: Cohort 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 2: Apixaban, 5 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Apixaban | Intervention Type: DRUG; Name: Apixaban; Assigned to Arm(s): Cohort 1: Apixaban, 10 mg, Cohort 1: Apixaban, 20 mg, Cohort 1: Apixaban, 5 mg, Cohort 2: Apixaban, 5 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2: Placebo
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: enoxaparin, Drug: chemotherapy with LMWH - enoxaparin | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: only chemotherapy | Intervention Type: DRUG; Name: enoxaparin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: chemotherapy with LMWH - enoxaparin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: only chemotherapy; Assigned to Arm(s): B
D: Arm Label: saline solution; Type: PLACEBO_COMPARATOR; Interventions: Drug: saline solution (placebo) | Arm Label: nadroparin calcium; Type: EXPERIMENTAL; Interventions: Drug: Nadroparin calcium | Intervention Type: DRUG; Name: Nadroparin calcium; Assigned to Arm(s): nadroparin calcium | Intervention Type: DRUG; Name: saline solution (placebo); Assigned to Arm(s): saline solution

Answer: A