TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Post MI Risk Modification Intervention Via Telemedicine Evaluation
Brief Summary: The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited from a large hospital and randomized to either the education group (control group) or one of the two intervention groups. Patients randomized to one of the intervention groups will receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based platform or solely the use of Microsoft's HealthVault web-based platform and web-based behavioral intervention, both of which includes a behavioral/medication management component. The 12 months effects of the intervention will be evaluated.

For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients will also be surveyed about demographics and health behaviors during the baseline and 12 months. Study personnel serve as a liaison between subjects and their providers; however, all decisions related to clinical care are ultimately left up to the patient's provider. Subjects with serious adverse effects will be advised and assisted in seeking emergency medical care.


Options:
A: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)
B: BP measurement (Measured at 6 months)
C: all cause mortality
D: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Post MI Risk Modification Intervention Via Telemedicine Evaluation
Brief Summary: The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited from a large hospital and randomized to either the education group (control group) or one of the two intervention groups. Patients randomized to one of the intervention groups will receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based platform or solely the use of Microsoft's HealthVault web-based platform and web-based behavioral intervention, both of which includes a behavioral/medication management component. The 12 months effects of the intervention will be evaluated.

For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients will also be surveyed about demographics and health behaviors during the baseline and 12 months. Study personnel serve as a liaison between subjects and their providers; however, all decisions related to clinical care are ultimately left up to the patient's provider. Subjects with serious adverse effects will be advised and assisted in seeking emergency medical care.


Options:
A: nicotinic weaning (1year); weight loss at least 5% (1 year); waist reduction at least 4% (1 year); physical activity at least 30 minute per day (3h per week) (1 year)
B: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
C: Within patient change in the Paffenbarger Exercise and Physical Activity Index (basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout)
D: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Post MI Risk Modification Intervention Via Telemedicine Evaluation
Brief Summary: The study is a three-arm design where up to 600 patients hospitalized post-MI are recruited from a large hospital and randomized to either the education group (control group) or one of the two intervention groups. Patients randomized to one of the intervention groups will receive a nurse-administered intervention plus the use of Microsoft's HealthVault web-based platform or solely the use of Microsoft's HealthVault web-based platform and web-based behavioral intervention, both of which includes a behavioral/medication management component. The 12 months effects of the intervention will be evaluated.

For baseline and outcome assessments we will obtain BP, nonfasting LDL, and Hb A1c. Patients will also be surveyed about demographics and health behaviors during the baseline and 12 months. Study personnel serve as a liaison between subjects and their providers; however, all decisions related to clinical care are ultimately left up to the patient's provider. Subjects with serious adverse effects will be advised and assisted in seeking emergency medical care.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: 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)
C: Change in individual anaerobic threshold according to lactate kinetics during spiroergometry (6 months)
D: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.
Brief Summary: Double blind, multinational, multicentre, randomised, 2 arm parallel group study


Options:
A: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
B: Pre-dose morning FEV1 measured at clinic visit 5 (12-week treatment)
C: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) (From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]))
D: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (Day 28 of the relevant treatment period (up to Study Day 112))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lamotrigine as an Antidepressant Augmentation Agent in Treatment Refractory Unipolar Depression
Brief Summary: This study is intended to evaluate the efficacy and safety of lamotrigine as an antidepressant augmentation agent in a sample of individuals with major depression and a history of both prior non-response and prospective failure to respond to at least one adequate trial of an antidepressant (for a total of two failed trials).


Options:
A: Rate of Protocol Remission of Symptoms of Major Depressive Disorder (During acute phase (12 weeks))
B: MADRS score (weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18, and 20)
C: Change in Total MADRS Scores From Baseline to Week 8 (Baseline, Week 8); Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) (Baseline, week 9); Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) (Baseline, Weeks 8)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Brief Summary: The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
C: sleep measures (3-6 months)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Brief Summary: The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.


Options:
A: Change in cognitive function summary score (12 weeks)
B: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: sleep measures (3-6 months)
D: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Brief Summary: The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.


Options:
A: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)
B: sleep measures (3-6 months)
C: overall cognition (2 Monhths)
D: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs
Brief Summary: The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.


Options:
A: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
B: sleep measures (3-6 months)
C: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
D: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
Brief Summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.


Options:
A: Overall survival comparison between treatment groups (every 4 weeks for 3 years)
B: Survival rate at 6 months (6 months)
C: Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
D: Progression-free survival rate at 6 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy
Brief Summary: The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and QOL in patients with pancreatic and periampullary cancers who have had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT). This pilot study will utilize the walking program developed by Mock et al. (2001), in their investigation of the improvement of fatigue and QOL in breast care patients following surgery who were receiving CT, RT or biotherapy. No studies published to date have utilized a progressive walking program in post-operative pancreas and ampullary cancers to determine if it reduces adverse effects, such as fatigue or improves functionality and QOL scores.


Options:
A: FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires (6 months)
B: Changes of health-related physical fitness components (1). (Changes from baseline aerobic capacity at 12 weeks); Changes of health-related physical fitness components (2). (Changes from baseline muscular endurance at 12 weeks); Changes of health-related physical fitness components (3). (Changes from baseline muscular strength at 12 weeks); Changes of health-related physical fitness components (4). (Changes from baseline muscular power at 12 weeks); Changes of health-related physical fitness components (5). (Changes from baseline agility at 12 weeks); Changes of health-related physical fitness components (6). (Changes from baseline flexibility at 12 weeks); Changes of anthropometric parameters (1). (Changes from baseline waist circumference at 12 weeks); Changes of anthropometric parameters (2). (Changes from baseline BMI at 12 weeks); Changes of body composition parameters (1). (Changes from baseline body fat mass at 12 weeks); Changes of body composition parameters (2). (Changes from baseline lean body mass at 12 weeks); Changes of body composition parameters (3). (Changes from baseline percentage body fat at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (1). (Changes from baseline serum levels of DKK1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (2). (Changes from baseline serum levels of Sclerostin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (3). (Changes from baseline serum levels of SFRP1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (4). (Changes from baseline serum levels of β-catenin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (5). (Changes from baseline serum levels of WISP-1 at 12 weeks)
C: Change in Physical activity Levels From Baseline to Month 1 and Month 3 (baseline, 1 month, 3 months)
D: Change in QoL between baseline and postintervention. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: 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)
B: Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum (6 months)
C: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
D: Cure rate (63 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
B: 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)
C: Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ (42 days)
D: Cure rate (63 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: Development of sexual stages of P.falciparum (42 days post treatment)
B: Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
C: Parasitological outcome after 28 days follow-up (28 days)
D: Cure rate (63 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: Cure rate (63 days)
B: 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)
C: Development of sexual stages of P.falciparum (42 days post treatment)
D: Parasitological outcome after 28 days follow-up (28 days)

Answer: A