TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Open-label Trial of a Rifapentine Plus Moxifloxacin-Based Regimen for Intensive Phase Treatment of Smear-Positive Pulmonary Tuberculosis
Brief Summary: Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications.

This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis.

The experimental regimen will consist of the following:

* Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

The standard control intensive phase regimen will consist of the following:

* Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen.

In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.


Options:
A: Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. (Daily, Days 1-3 or 4, and 7-14 days after dosing.)
B: Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). (18 months (within one year of completion of therapy)); Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) (18 months (within one year of completion of therapy))
C: To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. (Week 8); To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. (Weekly or more frequent)
D: • To compare the culture-conversion rate at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
Brief Summary: The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.


Options:
A: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
B: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)
C: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)
D: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
Brief Summary: The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: Mortality rate (10-year)
C: Motivation (12 weeks); Needs Satisfaction (12 weeks)
D: Total steps (last 30 days of intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
Brief Summary: The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.


Options:
A: Total steps (last 30 days of intervention)
B: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
C: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
D: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
Brief Summary: Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an "air muscle" has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.


Options:
A: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
B: Wolf Motor Function Test (8 Weeks)
C: Fugl Mayer motor score for upper extremity (4 weeks)
D: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
Brief Summary: Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an "air muscle" has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.


Options:
A: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
B: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
C: Wolf Motor Function Test (8 Weeks)
D: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
Brief Summary: 1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function.
2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.


Options:
A: Time to first documented recurrence of symptomatic sustained AF. (Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing); Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events (Safety assessments within Day 120 of dosing)
B: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
C: recurrence of atrial fibrillation (6 month)
D: Time to Recurrence of AF lasting longer than 15 seconds (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life
Brief Summary: The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeostasis, bone metabolism, and body composition.


Options:
A: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. (Week 24 of dosing)
B: Assess the feasability of PTH 1-34 therapy via pump.
C: Increase in maximal voluntary knee extension (6 months)
D: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. (8 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two Part Study to Investigate the Safety and Immunogenicity of the VAX125 Influenza Vaccine in Healthy Adults Age 18-49 Years Part I: Phase I, Open-Label, Escalating Dose-Ranging Study Part II: Phase II, Double-Blind Placebo-Controlled Study
Brief Summary: Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.


Options:
A: Safety (local and systemic reactogenicity, laboratory tests and AEs. (6 months)
B: Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine. (Day 21)
C: The number of laboratory-confirmed influenza cases in infants born to mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against laboratory-confirmed influenza illness in their infants (24 weeks of age); Humoral and cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in pregnant women vaccinated between 20-34 weeks of gestational age (one month post vaccination, delivery (+7 days), 24 weeks post natal)
D: The primary objective of safety and tolerability of GHB01L1 administered as single dose intranasal aerosol will be evaluated by clinical signs and symptoms as well as laboratory tests. (Beginning with signing Informed Consent through 30 days after study end)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
Brief Summary: This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).


Options:
A: Weight (Measured at Month 24)
B: hemoglobin A1c (1 year)
C: Time to first hospitalization due to worsened heart failure (15 months)
D: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Open-Label, Multicenter, Multidose, Dose Escalation Study of BMS-936558 (Nivolumab) in Subjects With Selected Advanced or Recurrent Malignancies
Brief Summary: The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.


Options:
A: Overall Survival (From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.)
B: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs (Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years); Number of Participants With Abnormal Serum Chemistry Laboratory Values (Day 1 up to June 2013, approximately 4 years); Number of Participants With Abnormal Hematology Laboratory Values (Day 1 up to June 2013, approximately 4 years)
C: Overall Survival (Up to 66 months)
D: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Open-Label, Multicenter, Multidose, Dose Escalation Study of BMS-936558 (Nivolumab) in Subjects With Selected Advanced or Recurrent Malignancies
Brief Summary: The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.


Options:
A: Overall Survival (Up to 66 months)
B: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
C: Progression-Free Survival (50Events)
D: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs (Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years); Number of Participants With Abnormal Serum Chemistry Laboratory Values (Day 1 up to June 2013, approximately 4 years); Number of Participants With Abnormal Hematology Laboratory Values (Day 1 up to June 2013, approximately 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial
Brief Summary: This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.


Options:
A: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
B: Operative blood loss (From skin incision to completion of operation); Operative time (From skin incision to completion of operation)
C: To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management (All patients will have their blood checked every 30 minutes during surgery)
D: Postoperative Complications (30 days post procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV
Brief Summary: This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.


Options:
A: Safety of MVA85A (Six months)
B: Safety of a single intradermal injection of 5 x 107pfu MVA85A (One year)
C: The induction of T-cell responses (6 months)
D: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Solar Water Disinfections: Randomized Intervention Trial
Brief Summary: The importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to:

* Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ;
* Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups;
* Document the actual use and acceptance of SODIS by participants in the study;
* Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level;
* Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.


Options:
A: N/A
B: Neonatal mortality rate
C: To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (20 months (Jan 2005 to Sep 2006)); - Reduction in visits to health care providers for treatment of illness (20 months (Jan 2005 to Sep 2006)); - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses (20 months (Jan 2005 to Sep 2006)); - Increase in ORS use during diarrhea in the intervention communities. (20 months (Jan 2005 to Sep 2006))
D: Incidence of diarrhea (weekly)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Solar Water Disinfections: Randomized Intervention Trial
Brief Summary: The importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to:

* Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ;
* Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups;
* Document the actual use and acceptance of SODIS by participants in the study;
* Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level;
* Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
C: Incidence of diarrhea (weekly)
D: Dysentery disease rate (12 month); Diarrhoea disease rate (12 months)

Answer: C