TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Brief Summary: Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.


Options:
A: Arm Label: Arm A: QHPV; Type: ACTIVE_COMPARATOR; Interventions: Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) | Arm Label: Arm B: Placebo/QHPV; Type: OTHER; Interventions: Other: Placebo/QHPV | Intervention Type: BIOLOGICAL; Name: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV); Assigned to Arm(s): Arm A: QHPV | Intervention Type: OTHER; Name: Placebo/QHPV; Assigned to Arm(s): Arm B: Placebo/QHPV
B: Arm Label: Cervarix 1/Placebo Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 1/Placebo/Cervarix 1 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 2/Placebo/Cervarix 2 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Drug: Placebo | Arm Label: Cervarix 2 Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix 1/Placebo Group, Cervarix 1/Placebo/Cervarix 1 Group, Cervarix 2 Group, Cervarix 2/Placebo/Cervarix 2 Group | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cervarix 1/Placebo Group, Cervarix 1/Placebo/Cervarix 1 Group, Cervarix 2/Placebo/Cervarix 2 Group
C: Arm Label: HPV Vaccine; Type: N/A; Interventions: N/A
D: Arm Label: 16-26 year olds 3 doses HPV Vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HPV (Human Papillomavirus) Vaccine | Arm Label: 3 dose 9-13 HPV Vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HPV (Human Papillomavirus) Vaccine | Arm Label: 2 dose 9-13 yrs HPV Vaccine; Type: ACTIVE_COMPARATOR; Interventions: Biological: HPV (Human Papillomavirus) Vaccine | Intervention Type: BIOLOGICAL; Name: HPV (Human Papillomavirus) Vaccine; Assigned to Arm(s): 16-26 year olds 3 doses HPV Vaccine, 2 dose 9-13 yrs HPV Vaccine, 3 dose 9-13 HPV Vaccine

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: Intervention Type: BEHAVIORAL; Name: Psychosocial treatment; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Anti-ADHD medication; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Assessment-and-Referral; Assigned to Arm(s): N/A
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Methylphenidate Transdermal System | Intervention Type: DRUG; Name: Methylphenidate Transdermal System; Assigned to Arm(s): 1
C: Intervention Type: DRUG; Name: methylphenidate hydrochloride; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: clonidine | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: methylphenidate | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: clonidine, Drug: methylphenidate | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: clonidine; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: methylphenidate; Assigned to Arm(s): 2, 3 | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): 4

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: Arm Label: OROS-methylphenidate; Type: N/A; Interventions: N/A | Arm Label: Atomoxetine group; Type: N/A; Interventions: N/A | Arm Label: Control group; Type: N/A; Interventions: N/A
B: Arm Label: Group 1: Guan-Guan+Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Guanfacine | Arm Label: Group 2: Placebo-Placebo+DMPH; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate (MPH) | Arm Label: Group 3: Guan-Guan+DMPH (Comb); Type: EXPERIMENTAL; Interventions: Drug: Guanfacine, Drug: Methylphenidate (MPH) | Intervention Type: DRUG; Name: Guanfacine; Assigned to Arm(s): Group 1: Guan-Guan+Placebo, Group 3: Guan-Guan+DMPH (Comb) | Intervention Type: DRUG; Name: Methylphenidate (MPH); Assigned to Arm(s): Group 2: Placebo-Placebo+DMPH, Group 3: Guan-Guan+DMPH (Comb)
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Methylphenidate Transdermal System | Intervention Type: DRUG; Name: Methylphenidate Transdermal System; Assigned to Arm(s): 1
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Methylphenidate HCl, Drug: Risperidone, Behavioral: Parent Management Training (PMT) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate HCl, Behavioral: Parent Management Training (PMT), Drug: Placebo | Intervention Type: DRUG; Name: Methylphenidate HCl; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Risperidone; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Parent Management Training (PMT); Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: Arm Label: Adhansia XR; Type: EXPERIMENTAL; Interventions: Drug: Adhansia XR | Arm Label: Concerta; Type: ACTIVE_COMPARATOR; Interventions: Drug: Concerta | Intervention Type: DRUG; Name: Adhansia XR; Assigned to Arm(s): Adhansia XR | Intervention Type: DRUG; Name: Concerta; Assigned to Arm(s): Concerta
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Methylphenidate Transdermal System | Intervention Type: DRUG; Name: Methylphenidate Transdermal System; Assigned to Arm(s): 1
C: Arm Label: Medication Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vyvanse, Drug: Methylphenidate | Arm Label: Behavioral Parent Training Arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral Parent Training | Intervention Type: DRUG; Name: Vyvanse; Assigned to Arm(s): Medication Arm | Intervention Type: BEHAVIORAL; Name: Behavioral Parent Training; Assigned to Arm(s): Behavioral Parent Training Arm | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Medication Arm
D: Arm Label: Methylphenidate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (tablet), Drug: Placebo (capsule) | Arm Label: LY2216684 (0.1 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Arm Label: LY2216684 (0.2 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Arm Label: LY2216684 (0.3 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Intervention Type: DRUG; Name: LY2216684; Assigned to Arm(s): LY2216684 (0.1 mg/kg/day), LY2216684 (0.2 mg/kg/day), LY2216684 (0.3 mg/kg/day) | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Methylphenidate | Intervention Type: DRUG; Name: Placebo (tablet); Assigned to Arm(s): Placebo | 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: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
Brief Summary: The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).


Options:
A: Arm Label: Intermittent bolus group; Type: ACTIVE_COMPARATOR; Interventions: Drug: 3% hypertonic saline | Arm Label: slow continuous infusion group; Type: ACTIVE_COMPARATOR; Interventions: Drug: 3% hypertonic saline | Intervention Type: DRUG; Name: 3% hypertonic saline; Assigned to Arm(s): Intermittent bolus group, slow continuous infusion group
B: Arm Label: Satavaptan; Type: EXPERIMENTAL; Interventions: Drug: Satavaptan | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Satavaptan; Assigned to Arm(s): Satavaptan | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DRUG; Name: satavaptan (SR121463B); Assigned to Arm(s): N/A
D: Arm Label: Tolvaptan; Type: EXPERIMENTAL; Interventions: Drug: Tolvaptan | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tolvaptan; Assigned to Arm(s): Tolvaptan | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Brief Summary: The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

* The safety and tolerability of multiple doses of INT 747;
* The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
* Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
* Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.


Options:
A: Arm Label: 25 mg INT-747; Type: ACTIVE_COMPARATOR; Interventions: Drug: INT-747 | Arm Label: 50 mg INT-747; Type: ACTIVE_COMPARATOR; Interventions: Drug: INT-747 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: INT-747; Assigned to Arm(s): 25 mg INT-747, 50 mg INT-747 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Resveratrol; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Resveratrol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Resveratrol; Assigned to Arm(s): Resveratrol | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DRUG; Name: metformin; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: Orlistat (Xenical); Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: 1400 kcal diet (30% fat); Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
Brief Summary: The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo\~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo\~CAT). The first extension is followed by another long-term study (PASCCAL-1).


Options:
A: Intervention Type: DRUG; Name: SR121463B; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: satavaptan (SR121463B); Assigned to Arm(s): N/A
C: Arm Label: Tolvaptan; Type: EXPERIMENTAL; Interventions: Drug: Tolvaptan | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tolvaptan; Assigned to Arm(s): Tolvaptan | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Tolvaptan, Samsca; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tolvaptan or Samsca | Arm Label: sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo or sugar pill | Intervention Type: DRUG; Name: Tolvaptan or Samsca; Assigned to Arm(s): Tolvaptan, Samsca | Intervention Type: DRUG; Name: placebo or sugar pill; Assigned to Arm(s): sugar pill

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Brief Summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Options:
A: Intervention Type: PROCEDURE; Name: bone marrow-derived stem cell transfer; Assigned to Arm(s): N/A
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: Adult stem cells | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Adult stem cells | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Adult stem cells; Assigned to Arm(s): 1, 2 | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): 3, 4
C: Intervention Type: DRUG; Name: G-CSF with/without darbepoetin, peripheral blood stem cell infusion; Assigned to Arm(s): N/A
D: Arm Label: Treated Group; Type: EXPERIMENTAL; Interventions: Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation | Arm Label: Control Group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation | Intervention Type: PROCEDURE; Name: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation; Assigned to Arm(s): Control Group, Treated Group

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Brief Summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Options:
A: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: 0.9% NaCl | Arm Label: verum; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin alfa | Intervention Type: DRUG; Name: recombinant human erythropoietin alfa; Assigned to Arm(s): verum | Intervention Type: DRUG; Name: 0.9% NaCl; Assigned to Arm(s): placebo
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Erythropoietin | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Erythropoietin; Assigned to Arm(s): A | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): B
C: Intervention Type: DRUG; Name: G-CSF with/without darbepoetin, peripheral blood stem cell infusion; Assigned to Arm(s): N/A
D: Arm Label: Epo1 and TT10; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo1 and TT7; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo2 and TT10; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Epo2 and TT7; Type: ACTIVE_COMPARATOR; Interventions: Drug: recombinant human erythropoietin, rhEpo | Arm Label: Placebo and TT10; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Arm Label: Placebo and TT7; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: recombinant human erythropoietin, rhEpo; Assigned to Arm(s): Epo1 and TT10, Epo1 and TT7, Epo2 and TT10, Epo2 and TT7 | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo and TT10, Placebo and TT7

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Intervention Type: DEVICE; Name: Early Bubble CPAP; Assigned to Arm(s): N/A
B: Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen
C: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Poractant alfa (Curosurf®) | Intervention Type: DRUG; Name: Poractant alfa (Curosurf®); Assigned to Arm(s): 2
D: Arm Label: PS Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: PS Group | Arm Label: NCPAP Group; Type: EXPERIMENTAL; Interventions: Device: NCPAP Group | Arm Label: ISX Group; Type: EXPERIMENTAL; Interventions: Drug: ISX Group | Intervention Type: DRUG; Name: PS Group; Assigned to Arm(s): PS Group | Intervention Type: DEVICE; Name: NCPAP Group; Assigned to Arm(s): NCPAP Group | Intervention Type: DRUG; Name: ISX Group; Assigned to Arm(s): ISX Group

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen
B: Intervention Type: DEVICE; Name: Early Bubble CPAP; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Poractant alfa (Curosurf®) | Intervention Type: DRUG; Name: Poractant alfa (Curosurf®); Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Very early surfactant and bubble NCPAP | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: bubble NCPAP | Intervention Type: OTHER; Name: Very early surfactant and bubble NCPAP; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: bubble NCPAP; Assigned to Arm(s): 2

Answer: C