TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking
Brief Summary: For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.

For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.


Options:
A: Product Effect on Complete Substitution for Smoking (6 week post smoking substitution); Number of Cigarettes Smoked (6 weeks post cigarette substitution); Number of Products Used (6 weeks post smoking substitution)
B: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)
C: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: NIMH Collaborative HIV/STD Prevention Trial
Brief Summary: This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.


Options:
A: Frequency of unprotected sexual acts with nonspousal partners (Measured at baseline and Years 1 and 2); Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens (Measured at baseline and Years 1 and 2)
B: HIV-1 seroincidence; HSV2 seroprevalence
C: Proportion of condom protected vaginal sex acts over the last 60 days (6 and 12 months post-randomization)
D: HIV incidence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
Brief Summary: Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.


Options:
A: Change of visual acuity over time (12 months)
B: N/A
C: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses (Up to 4 months)
D: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
Brief Summary: Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.


Options:
A: N/A
B: Change of visual acuity over time (12 months)
C: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)
D: change in best-corrected visual acuity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Brief Summary: Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD, but no evidence exists about the effect of long term application/home application.

This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.


Options:
A: all-cause mortality (one year)
B: Days from trial intervention to either hospital admission or death (1 year)
C: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)
D: Severe Respiratory Insufficiency (SRI) Questionnaire (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Brief Summary: Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD, but no evidence exists about the effect of long term application/home application.

This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.


Options:
A: Morbidity (Up to end of follow-up (data presented up to 15 years)); Lung Function (Up to end of follow-up (data presented up to 15 years)); Mortality (Up to end of follow-up (data presented up to 15 years))
B: Forced expiratory volume in 1 second (FEV1) (Measured at baseline); Emphysema, as shown on chest CT scan (Measured at baseline); Airway wall thickness on chest CT scan (Measured at baseline); COPD status (COPD participants versus control group participants) (Measured at baseline)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: all-cause mortality (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
B: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
B: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 (Week 0 and Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
B: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
C: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 (Week 0 and Week 16)
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
D: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
C: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
Brief Summary: The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.


Options:
A: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
B: 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))
C: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
Brief Summary: The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.


Options:
A: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
B: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))
C: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
D: clinical benefit of combining bevacizumab treatment to weekly paclitaxel (after 6 months of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients
Brief Summary: Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.


Options:
A: Change in serum phosphorus at Day 56 as compared to baseline (Day 56)
B: Effect on p-creol levels (3 months)
C: death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions (2 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth
Brief Summary: Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.


Options:
A: Number of Subjects Reporting Solicited Local Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Solicited General Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (During the 31-days follow-up period after each dose of the study vaccine.); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the entire study period (from Dose 1 up to one month following last vaccine dose).)
B: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
C: Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. (1 month post-dose 3 (primary vaccination series))
D: Mortality by sex

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Pilot Pragmatic Single-Blinded Fast Track Randomised Controlled Trial of the Breathlessness Intervention Service Versus Standard Care for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The aim of this study is to test the feasibility of conducting a pragmatic fast track Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus standard care for patients with COPD and their carers, and to begin testing the effectiveness of the intervention.


Options:
A: Primary study outcomes are patients' self report of the severity of dyspnea and HRQOL. Baseline dyspnea will be quantified with the Baseline Dyspnea Index and Borg scale with regular measures of dyspnea using the Visual Analog Scale (VAS). HRQOL will be (8 weeks)
B: Inspiratory Capacity (at 0th, 5th, ~20th minutes of exercises); Borg scale (at 0th and 20th minutes of exercises)
C: Visual Analogue Scale (VAS) - distress due to breathlessness (End of intervention (8 weeks after baseline))
D: thoracoabdominal motion (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy
Brief Summary: Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women and children are the most vulnerable population. Malaria in pregnancy increases the risks of abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia are recommended.

HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV infected persons, and CTX prophylaxis significantly improves birth outcomes in immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we aim to establish the safety and efficacy of daily CTX in preventing malaria infection during pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This information is urgently needed to assist to issue guidelines on IPT in pregnancy.


Options:
A: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
B: Number of Participants With Placental Malaria (at delivery estimated to be within 10 to 30 weeks of study entry); Incidence of Malaria, Pregnant Women (Time at risk will begin following administration of first dose of study drug to delivery)
C: To test the hypothesis that co-trimoxazole prophylaxis is not inferior to SP intermittent preventive treatment in preventing placental malaria. (Pregnancy)
D: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Brief Summary: This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.


Options:
A: The time to first occurrence of a major cardiovascular disease event
B: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
C: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
D: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)

Answer: C