TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Low Carbohydrate Portfolio or "Eco-Atkins" Diet
Brief Summary: Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss.


Options:
A: Arm Label: Lifestyle Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Arm Label: Diabetes Support and Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diabetes Support and Education | Intervention Type: BEHAVIORAL; Name: Lifestyle Intervention; Assigned to Arm(s): Lifestyle Intervention | Intervention Type: BEHAVIORAL; Name: Diabetes Support and Education; Assigned to Arm(s): Diabetes Support and Education
B: Arm Label: Eco-Atkins diet; Type: EXPERIMENTAL; Interventions: Other: Eco-Atkins diet (high vegetable protein and vegetable fat) | Arm Label: NCEP diet; Type: ACTIVE_COMPARATOR; Interventions: Other: NCEP diet | Intervention Type: OTHER; Name: Eco-Atkins diet (high vegetable protein and vegetable fat); Assigned to Arm(s): Eco-Atkins diet | Intervention Type: OTHER; Name: NCEP diet; Assigned to Arm(s): NCEP diet
C: Arm Label: diet following American Diabetes Association guidelines; Type: ACTIVE_COMPARATOR; Interventions: Other: diet following ADA guidelines | Arm Label: vegan diet; Type: EXPERIMENTAL; Interventions: Other: vegan diet | Intervention Type: OTHER; Name: vegan diet; Assigned to Arm(s): vegan diet | Intervention Type: OTHER; Name: diet following ADA guidelines; Assigned to Arm(s): diet following American Diabetes Association guidelines
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet | Intervention Type: BEHAVIORAL; Name: Low-fat, low-Glycemic Index, vegan diet; Assigned to Arm(s): 1, 2

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Brief Summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.


Options:
A: Intervention Type: DRUG; Name: Gefitinib; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Vinorelbine; Assigned to Arm(s): N/A
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Gefitinib | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Paclitaxel | Intervention Type: DRUG; Name: Gefitinib; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): 2
C: Intervention Type: DRUG; Name: Gefitinib; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): N/A
D: Arm Label: Osimertinib; Type: EXPERIMENTAL; Interventions: Drug: Chemotherapy, Drug: Cross-over to Osimertinib | Arm Label: Platinum-based doublet chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chemotherapy | Intervention Type: DRUG; Name: Chemotherapy; Assigned to Arm(s): Osimertinib, Platinum-based doublet chemotherapy | Intervention Type: DRUG; Name: Cross-over to Osimertinib; Assigned to Arm(s): Osimertinib

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Brief Summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.


Options:
A: Arm Label: BIBW 2992; Type: EXPERIMENTAL; Interventions: Drug: BIBW 2992 | Arm Label: Cisplatin/Pemetrexed; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pemetrexed, Drug: Cisplatin | Intervention Type: DRUG; Name: Pemetrexed; Assigned to Arm(s): Cisplatin/Pemetrexed | Intervention Type: DRUG; Name: BIBW 2992; Assigned to Arm(s): BIBW 2992 | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Cisplatin/Pemetrexed
B: Arm Label: Icotinib; Type: EXPERIMENTAL; Interventions: Drug: Icotinib | Arm Label: Chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chemotherapy | Intervention Type: DRUG; Name: Icotinib; Assigned to Arm(s): Icotinib | Intervention Type: DRUG; Name: Chemotherapy; Assigned to Arm(s): Chemotherapy
C: Arm Label: erlotinib; Type: EXPERIMENTAL; Interventions: Drug: erlotinib | Arm Label: gemcitabine/carboplatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: gemcitabine/carboplatin | Intervention Type: DRUG; Name: erlotinib; Assigned to Arm(s): erlotinib | Intervention Type: DRUG; Name: gemcitabine/carboplatin; Assigned to Arm(s): gemcitabine/carboplatin
D: Intervention Type: DRUG; Name: Gefitinib; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Vinorelbine; Assigned to Arm(s): N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Brief Summary: This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.


Options:
A: Arm Label: Group 1 - Paromomycin cream; Type: EXPERIMENTAL; Interventions: Drug: Paromomycin Sulfate | Arm Label: Group 2. Local Injectable Pentamidine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pentamidine Isethionate | Arm Label: Group 3. Vehicle control; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Paromomycin Sulfate; Assigned to Arm(s): Group 1 - Paromomycin cream | Intervention Type: DRUG; Name: Pentamidine Isethionate; Assigned to Arm(s): Group 2. Local Injectable Pentamidine | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Group 3. Vehicle control
B: Intervention Type: DRUG; Name: Imiquimod; Assigned to Arm(s): N/A
C: Intervention Type: BIOLOGICAL; Name: Leish-111f + MPL-SE vaccine; Assigned to Arm(s): N/A
D: Arm Label: Liposomal Amphotericin; Type: EXPERIMENTAL; Interventions: Drug: Liposomal Amphotericin B | Intervention Type: DRUG; Name: Liposomal Amphotericin B; Assigned to Arm(s): Liposomal Amphotericin

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Brief Summary: The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: Botulinum toxin type A | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: Botulinum toxin type A; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
B: Arm Label: Dysport NG; Type: EXPERIMENTAL; Interventions: Biological: Botulinum toxin type A | Arm Label: Dysport; Type: ACTIVE_COMPARATOR; Interventions: Biological: Botulinum toxin type A | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: Botulinum toxin type A; Assigned to Arm(s): Dysport NG | Intervention Type: BIOLOGICAL; Name: Botulinum toxin type A; Assigned to Arm(s): Dysport | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: N/A
D: Arm Label: Dysport®; Type: ACTIVE_COMPARATOR; Interventions: Biological: Botulinum toxin type A | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: Botulinum toxin type A; Assigned to Arm(s): Dysport® | 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: Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
Brief Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients


Options:
A: Intervention Type: DRUG; Name: pitavastatin; Assigned to Arm(s): N/A
B: Arm Label: Pitavastatin 4 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Pitavastatin | Arm Label: Pravastatin 40 mg QD; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pravastatin | Intervention Type: DRUG; Name: Pitavastatin; Assigned to Arm(s): Pitavastatin 4 mg QD | Intervention Type: DRUG; Name: Pravastatin; Assigned to Arm(s): Pravastatin 40 mg QD
C: Arm Label: Treatment sequence A, B; Type: EXPERIMENTAL; Interventions: Drug: pitavastatin, Drug: placebo | Arm Label: Treatment sequence B, A; Type: EXPERIMENTAL; Interventions: Drug: pitavastatin, Drug: placebo | Intervention Type: DRUG; Name: pitavastatin; Assigned to Arm(s): Treatment sequence A, B, Treatment sequence B, A | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Treatment sequence A, B, Treatment sequence B, A
D: Arm Label: Pitavastatin 1 mg; Type: EXPERIMENTAL; Interventions: Drug: Pitavastatin | Arm Label: Pravastatin 10 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pravastatin | Arm Label: Pitavastatin 2 mg; Type: EXPERIMENTAL; Interventions: Drug: Pitavastatin | Arm Label: Pravastatin 20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pravastatin | Arm Label: Pitavastatin 4 mg; Type: EXPERIMENTAL; Interventions: Drug: Pitavastatin | Arm Label: Pravastatin 40 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pravastatin | Intervention Type: DRUG; Name: Pitavastatin; Assigned to Arm(s): Pitavastatin 1 mg, Pitavastatin 2 mg, Pitavastatin 4 mg | Intervention Type: DRUG; Name: Pravastatin; Assigned to Arm(s): Pravastatin 10 mg, Pravastatin 20 mg, Pravastatin 40 mg

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
Brief Summary: Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".


Options:
A: Intervention Type: BEHAVIORAL; Name: behavioral swallowing exercises/ strategies; Assigned to Arm(s): N/A
B: Arm Label: Intervention with energy dense formula; Type: EXPERIMENTAL; Interventions: Other: Calogen® - an energy dense oleic acid based formula | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Calogen® - an energy dense oleic acid based formula; Assigned to Arm(s): Intervention with energy dense formula
C: Arm Label: Protein enriched yoghurt drink and bread; Type: EXPERIMENTAL; Interventions: Other: Protein enriched yoghurt drink and bread | Arm Label: Regular yoghurt drink and bread; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Protein enriched yoghurt drink and bread; Assigned to Arm(s): Protein enriched yoghurt drink and bread
D: Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Treatment as usual | Arm Label: Received nutrition supplement as needed; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Nutritional supplement, Other: Treatment as usual | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutritional supplement; Assigned to Arm(s): Received nutrition supplement as needed | Intervention Type: OTHER; Name: Treatment as usual; Assigned to Arm(s): Control, Received nutrition supplement as needed

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
Brief Summary: The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.


Options:
A: Arm Label: A1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lithium or Valproate with placebo (PBO) | Arm Label: A2; Type: EXPERIMENTAL; Interventions: Drug: Lithium or Valproate with Aripiprazole | Intervention Type: DRUG; Name: Lithium or Valproate with placebo (PBO); Assigned to Arm(s): A1 | Intervention Type: DRUG; Name: Lithium or Valproate with Aripiprazole; Assigned to Arm(s): A2
B: Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: aripiprazole; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aripiprazole | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aripiprazole | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aripiprazole; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 3

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 12-week Prospective, Double-blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.
Brief Summary: The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.


Options:
A: Arm Label: botulinum toxin Type A; Type: EXPERIMENTAL; Interventions: Biological: Botulinum Toxin Type A | Arm Label: Placebo (saline); Type: PLACEBO_COMPARATOR; Interventions: Other: placebo (saline) | Intervention Type: BIOLOGICAL; Name: Botulinum Toxin Type A; Assigned to Arm(s): botulinum toxin Type A | Intervention Type: OTHER; Name: placebo (saline); Assigned to Arm(s): Placebo (saline)
B: Intervention Type: DRUG; Name: Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection; Assigned to Arm(s): N/A
C: Arm Label: botulinum toxin Type A; Type: EXPERIMENTAL; Interventions: Biological: Botulinum Toxin Type A | Arm Label: Placebo (saline); Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo (saline) | Intervention Type: BIOLOGICAL; Name: Botulinum Toxin Type A; Assigned to Arm(s): botulinum toxin Type A | Intervention Type: OTHER; Name: Placebo (saline); Assigned to Arm(s): Placebo (saline)
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Erenumab 70 mg QM; Type: EXPERIMENTAL; Interventions: Drug: Erenumab | Arm Label: Erenumab 140 mg QM; Type: EXPERIMENTAL; Interventions: Drug: Erenumab | Intervention Type: DRUG; Name: Erenumab; Assigned to Arm(s): Erenumab 140 mg QM, Erenumab 70 mg QM | 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: Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
Brief Summary: Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia before the introduction of antibiotics in the mid-1900s. The purpose of this study is to determine if OMT, when used in conjunction with antibiotics and other usual care, will improve the recovery of elderly pneumonia patients.


Options:
A: Arm Label: Experimental group; Type: EXPERIMENTAL; Interventions: Other: Experimental group | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Control group | Intervention Type: OTHER; Name: Experimental group; Assigned to Arm(s): Experimental group | Intervention Type: OTHER; Name: Control group; Assigned to Arm(s): Control group
B: Arm Label: Physiotherapy+conventional treatment; Type: EXPERIMENTAL; Interventions: Other: Physiotherapy+conventional treatment | Arm Label: Conventional treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Conventional treatment | Intervention Type: OTHER; Name: Physiotherapy+conventional treatment; Assigned to Arm(s): Physiotherapy+conventional treatment | Intervention Type: DRUG; Name: Conventional treatment; Assigned to Arm(s): Conventional treatment
C: Arm Label: Experimental group; Type: EXPERIMENTAL; Interventions: Other: Physiotherapy program | Arm Label: Control group; Type: OTHER; Interventions: Drug: cephalosporin with or without erythromycin | Intervention Type: DRUG; Name: cephalosporin with or without erythromycin; Assigned to Arm(s): Control group | Intervention Type: OTHER; Name: Physiotherapy program; Assigned to Arm(s): Experimental group
D: Arm Label: Osteopathic Manipulative Treatment; Type: EXPERIMENTAL; Interventions: Procedure: Osteopathic Manipulative Treatment | Arm Label: Light-touch Treatment; Type: SHAM_COMPARATOR; Interventions: Procedure: Light-touch Treatment | Arm Label: Conventional Care Only; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Osteopathic Manipulative Treatment; Assigned to Arm(s): Osteopathic Manipulative Treatment | Intervention Type: PROCEDURE; Name: Light-touch Treatment; Assigned to Arm(s): Light-touch Treatment

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Arm Label: Low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: pantoprazole sodium enteric-coated spheroid suspension | Arm Label: High dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: pantoprazole sodium enteric-coated spheroid suspension | Intervention Type: DRUG; Name: pantoprazole sodium enteric-coated spheroid suspension; Assigned to Arm(s): High dose, Low dose
B: Intervention Type: DRUG; Name: pantoprazole for approximately 9 weeks.; Assigned to Arm(s): N/A
C: Arm Label: Lansoprazole QD; Type: EXPERIMENTAL; Interventions: Drug: Lansoprazole microgranules suspension | Arm Label: Placebo QD; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Lansoprazole microgranules suspension; Assigned to Arm(s): Lansoprazole QD | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo QD
D: Arm Label: Open Label Esomeprazole; Type: EXPERIMENTAL; Interventions: Drug: Open Label Run In Esomeprazole | Arm Label: Double Blind Esomeprazole; Type: EXPERIMENTAL; Interventions: Drug: Double Blind Esomeprazole | Arm Label: Double Blind Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Double Blind Placebo | Intervention Type: DRUG; Name: Open Label Run In Esomeprazole; Assigned to Arm(s): Open Label Esomeprazole | Intervention Type: DRUG; Name: Double Blind Esomeprazole; Assigned to Arm(s): Double Blind Esomeprazole | Intervention Type: DRUG; Name: Double Blind Placebo; Assigned to Arm(s): Double Blind Placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Arm Label: Oral omeprazole; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Rectal omeprazole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Omeprazole rectally 1mg/kg | Intervention Type: DRUG; Name: Omeprazole rectally 1mg/kg; Assigned to Arm(s): Rectal omeprazole
B: Arm Label: Dexlansoprazole MR 30 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Dexlansoprazole MR | Arm Label: Dexlansoprazole MR 60 mg QD; Type: EXPERIMENTAL; Interventions: Drug: Dexlansoprazole MR | Intervention Type: DRUG; Name: Dexlansoprazole MR; Assigned to Arm(s): Dexlansoprazole MR 30 mg QD | Intervention Type: DRUG; Name: Dexlansoprazole MR; Assigned to Arm(s): Dexlansoprazole MR 60 mg QD
C: Arm Label: Low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: pantoprazole sodium enteric-coated spheroid suspension | Arm Label: High dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: pantoprazole sodium enteric-coated spheroid suspension | Intervention Type: DRUG; Name: pantoprazole sodium enteric-coated spheroid suspension; Assigned to Arm(s): High dose, Low dose
D: Intervention Type: DRUG; Name: Esomeprazole (Nexium); Assigned to Arm(s): N/A

Answer: C