TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload
Brief Summary: A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.


Options:
A: Change From Baseline in Liver Iron Concentration (LIC) (Change from baseline to Week 52)
B: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
C: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)
D: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload
Brief Summary: A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.


Options:
A: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)
B: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
C: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
D: The primary outcome measure is to assess the safety and tolerability of combining DFO and deferasirox in thalassemia subjects with translation iron overload. (34 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluvastatin in the Therapy of Acute Coronary Syndrome
Brief Summary: This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.


Options:
A: Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
B: plaque volume (one year)
C: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
D: Reduction of LDL-C following 12 weeks of treatment

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluvastatin in the Therapy of Acute Coronary Syndrome
Brief Summary: This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.


Options:
A: Reduction in Low density lipoprotein cholesterol (LDL-C) (week 6 and 12)
B: Change from baseline in low density lipoprotein cholesterol after 12 weeks
C: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
D: compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin (4 weeks); Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose. (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
Brief Summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.


Options:
A: Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. (Baseline, 12 months)
B: Disease Free Survival. (8 years)
C: Time to the First On-Study SRE (Non-inferiority) (Up to 40.5 months)
D: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
B: pain subscale of the WOMAC (week 12)
C: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
B: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
C: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Options:
A: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) (Primary: 12months.)
B: Safety and tolerability of COV155 (Up to 35 days)
C: Lequesne Index
D: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Options:
A: pain subscale of the WOMAC (week 12)
B: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
C: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
D: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Options:
A: Change in 100mm Pain VAS (baseline throgh week 8)
B: Safety and tolerability of COV155 (Up to 35 days)
C: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
D: Sum of Pain Intensity Difference (SPID) at Hour 48 (Hour 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Options:
A: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
B: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
C: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
B: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
C: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Options:
A: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
B: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
C: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
D: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.


Options:
A: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
B: pain subscale of the WOMAC (week 12)
C: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Brief Summary: This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.


Options:
A: pain in the target knee (WOMAC pain index);; functional capacity in the target knee (WOMAC function index); and; global rating of benefit (100 mm Visual Analogue Scale, VAS).
B: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
C: Incidence of treatment-emergent adverse events; Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
D: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload
Brief Summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.


Options:
A: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
B: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
C: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
D: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload
Brief Summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.


Options:
A: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
B: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
C: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
D: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload
Brief Summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.


Options:
A: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)
B: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
C: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
D: The primary outcome measure is to assess the safety and tolerability of combining DFO and deferasirox in thalassemia subjects with translation iron overload. (34 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Brief Summary: Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut


Options:
A: Progression Free Survival (PFS) (up to approx. 18 months)
B: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) (Up to 7 years)
C: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
D: Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors (1 year); the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Intervention for Preterm Infants
Brief Summary: The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.

The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.


Options:
A: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)
B: Length of Stay (From Infant's birth to discharge from NICU)
C: Motor development. (2 months corrected age and 8 months corrected age)
D: Changes in Infant Motor Profile (IMP) (Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3))

Answer: A