TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Open-label Phase III Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients
Brief Summary: Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug


Options:
A: Change From Baseline in Liver Iron Concentration (LIC) (Change from baseline to Week 52)
B: 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)
C: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)
D: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Open-label Phase III Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients
Brief Summary: Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug


Options:
A: Myocardial T2*
B: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)
C: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
D: difference between multiple observations of the serum ferritin concentrations (five-year treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.
Brief Summary: The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)


Options:
A: Heart Failure Mortality (5 years); Changes in Left Ventricular Ejection Fraction (5 years)
B: increase of the ejection fraction of the left ventricle (1 year)
C: Number of Temporary Weans From LVAD Support Tolerated (up to 6 months); Number of Participants With Adverse Events (up to 6 months)
D: Global Left Ventricular Ejection Fraction change (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.
Brief Summary: The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)


Options:
A: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
B: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)
C: Global Left Ventricular Ejection Fraction change (6 months)
D: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
Brief Summary: This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).


Options:
A: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
B: Longest Duaration of Achieved Abstinance (12 weeks of treatment); Percentage Samples Submitted Negative for Crack Cocaine Use (12 weeks); Number of Participants Completing 4, 8 and 12 Weeks of Treatment (Number of participant retained in treatment at weeks 4, 8 and 12.); Treatment Attendance (12 weeks)
C: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)
D: HIV Viral Load (15 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
Brief Summary: This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).


Options:
A: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
B: longest continuous period of cocaine abstinence (Week 8)
C: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
D: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Intervention for Drug Abusing Students
Brief Summary: The purpose of this clinical trail is to evaluate the efficacy of a brief, cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug abuse (MMDA). This school-based initiative employs a collaborative effort between the University of Minnesota researchers and the St. Paul Public Schools. This intervention aims to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and problem-solving skills.


Options:
A: Substance use will be assessed using items extracted from the Monitoring the Future Study. (Three years); Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. (Three years)
B: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
C: Drug use frequency and quantity at 1-, 3- and 12-months post-intervention. (1 year post treatment)
D: Self-reported drunkenness (12 months); Self-reported drunkenness (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Brief Summary: The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.


Options:
A: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
B: Progression Free Survival (PFS) (every 12 weeks until progression or up to 30 months, thereafter every 6 months)
C: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization until PD or death, whichever occurred first (up to 28 months))
D: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Brief Summary: The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.


Options:
A: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
B: Progression-free Survival (PFS) (From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months))
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Brief Summary: The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.


Options:
A: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
B: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
C: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study
Brief Summary: The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a 7.5% higher combined failure rate, as compared to standard care practice (current guidelines for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration, respectively.


Options:
A: the risk of disease specific failure (within 1 month COPD)
B: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
C: mortality/survival (28 day)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin Guided Antibiotic Therapy and Hospitalisation in Patients With Lower Respiratory Tract Infections: The "ProHOSP" Study
Brief Summary: The aim of this study is to test if procalcitonin (PCT) guided antibiotic stewardship in patients with lower respiratory tract infection (LRTI) will be non-inferior, with at worst a 7.5% higher combined failure rate, as compared to standard care practice (current guidelines for LRTI) with reduced total antibiotic (AB) use and hospitalization rate and duration, respectively.


Options:
A: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: the risk of disease specific failure (within 1 month COPD)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. In an ongoing Phase 2a study being performed at the Hadassah University Hospital - Mount Scopus in Israel, patients with nonsense-mutation-mediated CF have received PTC124 in two 14-day treatment courses. Preliminary results from that study indicate that PTC124 has pharmacodynamic activity of PTC124 in CF and that PTC124 can be safely administered in this patient population. This Phase 2b extension study is designed to evaluate the activity and safety of 3 months (approximately 84 days) of continuous treatment with PTC124 in the same patients who were enrolled to the Phase 2a study. The main purpose of this study is to understand whether PTC124 can be safely administered and achieve pharmacodynamic activity in patients with CF due to a nonsense mutation.


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score (From Baseline Through Week 24)
D: CFTR activity as assessed by nasal transepithelial potential difference (TEPD) (84 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. PTC124 has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. In an ongoing Phase 2a study being performed at the Hadassah University Hospital - Mount Scopus in Israel, patients with nonsense-mutation-mediated CF have received PTC124 in two 14-day treatment courses. Preliminary results from that study indicate that PTC124 has pharmacodynamic activity of PTC124 in CF and that PTC124 can be safely administered in this patient population. This Phase 2b extension study is designed to evaluate the activity and safety of 3 months (approximately 84 days) of continuous treatment with PTC124 in the same patients who were enrolled to the Phase 2a study. The main purpose of this study is to understand whether PTC124 can be safely administered and achieve pharmacodynamic activity in patients with CF due to a nonsense mutation.


Options:
A: CFTR activity as assessed by nasal transepithelial potential difference (TEPD) (84 days)
B: Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline (Baseline (Week 1)); Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 (End of Treatment (EOT) (Week 48))
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label Comparative Study to Determine the Proportion of Asthma Patients on SERETIDE Diskus 50/250 mcg b.i.d. Achieving Total Control When Given Medication and Compliance Enhancement Training Compared to Those Receiving Medication Only
Brief Summary: This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.


Options:
A: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
B: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
C: number of subjects who achieved Total asthma Control: Period 2 (Up to Week 24)
D: medication adherence (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
Brief Summary: The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. In this double-blind study, both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week. The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room. While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths. This study hopes to be the first.


Options:
A: Onset meaningful pain reduction
B: Mean pain score
C: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
Brief Summary: The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. In this double-blind study, both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week. The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room. While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths. This study hopes to be the first.


Options:
A: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)
B: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
C: Difference between treatment groups in responder rates. (3 Months)
D: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
Brief Summary: The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. In this double-blind study, both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week. The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room. While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths. This study hopes to be the first.


Options:
A: Changes in pain (6 months)
B: Number of Participants With Composite Endpoint Success (3 months)
C: Evaluation of pain (28 days)
D: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study
Brief Summary: Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.

It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.

The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.


Options:
A: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
B: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
C: Prevalence and severity of LVD (5 year)
D: CV Death or Heart Failure Hospitalization (24 Months)

Answer: A