TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Iron Balance Study Comparing Deferasirox, Deferoxamine and the Combination of Both Drugs
Brief Summary: Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron present in the transfused blood remains in the body where it can cause a variety of organ dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even with good compliance, the iron excretion induced by a given drug exhibits wide subject-to-subject variability. There is often persistent iron overload of extra hepatic tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the drugs may be a better approach in those subjects at increased risk. The iron balance studies proposed will permit an assessment of the potential of such a combination to place subjects in net negative iron balance and the relative effectiveness of the combination in relation to that of the individual drugs, an additive effect being expected. With such information, physicians will be able to design individualized chelation regimens that maximize effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule of the two drugs.


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: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
C: 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)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Brief Summary: This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.


Options:
A: Percentage of Participants Who Died (Baseline up to 4.25 years); Overall Survival (OS) Duration (Baseline until death (up to 4.25 years))
B: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
C: total Progression Free Survival (Last patient last visit (LPLV) to October 2013)
D: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (Total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib. (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: biologically verified smoking cessation or reduction (8 weeks and delivery)
B: Smoking Status (at week 48)
C: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: Rating of urges to smoke 1-week after the target quit (1 week)
D: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
B: Rating of urges to smoke 1-week after the target quit (1 week)
C: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
D: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: N/A
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
Brief Summary: This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.


Options:
A: Number of Participants With a Quit Attempt (6 months)
B: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
C: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.
Brief Summary: The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.


Options:
A: Progression-free survival (PFS) based on independent review committee (up to 6 years)
B: Lenalidomide Maximum Tolerated Dose (Dose escalation stage)
C: Progression-Free Survival (PFS) (Up to 84 months)
D: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Brief Summary: An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.


Options:
A: Maternal malaria at delivery (Delivery)
B: Incidence of clinical malaria (2008-2009)
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Brief Summary: An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.


Options:
A: Mean Hb at the end of the high transmission season.
B: Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms (90 days)
C: Parasite clearance time
D: Incidence of clinical malaria (2008-2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Brief Summary: An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.


Options:
A: Clinical malaria in the first year of life
B: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
C: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
D: Incidence of clinical malaria (2008-2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Brief Summary: An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.


Options:
A: Prevalence of anaemia (Hb <112g/L) (March 2006)
B: Incidence of clinical malaria (2008-2009)
C: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
D: Prevalence of drug resistance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Brief Summary: An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.


Options:
A: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)
B: Incidence of clinical malaria (2008-2009)
C: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
D: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
Brief Summary: Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.


Options:
A: Exacerbation Rate (From randomization to the patients final study visit (up to 12 months))
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
C: Treatment failure defined as: death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD; and the necessity to intensify pharmacologic treatment
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
Brief Summary: Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
B: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
C: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))
D: Exacerbation Rate (From randomization to the patients final study visit (up to 12 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Sea Buckthorn Oil on Dry Eye
Brief Summary: The objective is to study the effect of sea buckthorn oil on dry eye.


Options:
A: Schirmer tear test (Screening, Week 4, Week 12, Week 24); Ocular Surface Disease Index (Screening, Week 4, Week 12, Week 24); Tear Breakup Time (Screening, Week 4, Week 12, Week 24); Corneal Staining with Fluorescein (Screening, Week 4, Week 12, Week 24); Impression Cytology (Screening, Week 12, Week 24); Conjunctival staining with lissamine (Screening, Week 4, Week 12, Week 24)
B: Symptom severity: symptom questionnaires and clinical dry eye tests (3 months intervention + 1 month after the intervention)
C: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
D: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.
Brief Summary: The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.


Options:
A: Global Response Assessment (GRA) (12 Weeks)
B: Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. (12 WEEKS); Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). (12 WEEKS)
C: Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (Baseline and 1 month)
D: Change From Baseline in the Average Daily Bladder Pain Score (e-Diary) (Baseline to Week 6)

Answer: B