TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mental Stress Reduction in Defibrillator Patients
Brief Summary: The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators


Options:
A: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
B: Mental Stress Induced Elevation in "Double Product" by Math Stress Task (Immediate to 6 months post intervention); Mental Stress Induced Elevation in Double Product by Math Stress Task (3 months post intervention); Mental Stress Induced Elevation in "Double Product" by Anger-recall Task (Immediate to 6 months post intervention)
C: Anxiety (Baseline); Anxiety (14 weeks); Anxiet (26 weeks); Anxiety (52 weeks)
D: Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mental Stress Reduction in Defibrillator Patients
Brief Summary: The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators


Options:
A: Cardiopulmonary function (Measured at Week 8)
B: Quality of life (3 -6-12 month); Physical capability (3-6-12 month)
C: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
D: Mental Stress Induced Elevation in "Double Product" by Math Stress Task (Immediate to 6 months post intervention); Mental Stress Induced Elevation in Double Product by Math Stress Task (3 months post intervention); Mental Stress Induced Elevation in "Double Product" by Anger-recall Task (Immediate to 6 months post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
Brief Summary: This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress


Options:
A: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
B: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)
C: level of COMFORT with videotaped COMFORT behavior scale (first 24 hours postoperative)
D: technical quality of the LP, classified as success or failure. (immediate)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
Brief Summary: This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress


Options:
A: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
B: Pain response(Premature Infant Pain Profile (PIPP) (Baseline until completion of heelstick)
C: level of COMFORT with videotaped COMFORT behavior scale (first 24 hours postoperative)
D: Post-operative pain score (Daily average for 7 days); Change in post-operative pain score with intervention (Daily for 7 days); Heart rate (Daily average for 7 days); Respiratory rate (Daily average for 7 days); Oxygen saturation (Daily average for 7 days); Change in heart rate with intervention (Daily for 7 days); Change in respiratory rate with intervention (Daily for 7 days); Change in oxygen saturation with intervention (Daily for 7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development
Brief Summary: Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.

The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.


Options:
A: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (16 weeks)
B: Common infections
C: Adverse reactions (3 months and 6 months)
D: Body composition (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: Number of patients requiring Renal Replacement Therapy (participants will be followed for the duration of intensive care unit stay, an expected average of one week)
B: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)
C: 90-day mortality (90 day)
D: Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. (Up to 6 weeks post-operative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: 90-day mortality (90 day)
B: mortality
C: Septic shock (14 days)
D: Mortality rates (measured at time of hospital discharge or 60 days after study entry)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: 90-day mortality (90 day)
B: Rate of non-response to empiric antimicrobial treatment (5 days)
C: Time to clinical stability (30 days)
D: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality.
B: Mean Change in Protein C Levels From Day 1 to Day 7 (Day 1, Day 7)
C: Mortality or dialysis-dependency (90 days)
D: 90-day mortality (90 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Brief Summary: This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.

The study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo.

After enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.


Options:
A: HIV Seroconversion (Monthly follow-up through a median of 1.2 years); Grade 1 or Higher Creatinine Toxicity (Duration of follow-up, median 1.2 years); Grade 3 or Higher Phosphorous Toxicity (The entire follow-up period, median 1.2 years); Grade 2, 3, or 4 Laboratory Adverse Events (Entire follow-up, median 1.2 years); Grade 2, 3, or 4 Clinical Adverse Events (Entire follow-up, median 1.2 years)
B: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants (Up to 36 months); Number of Participants With Serious Adverse Events (SAEs) (Up to 36 months)
C: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years); HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms (Monthly, for up to 3 years)
D: HIV Infection (Cumulative HIV infection between enrollment and 52 weeks); Confirmed Grade 2 or Higher Serum Creatinine Toxicity (cumulative toxicity through 52 weeks of product use and 4 weeks post product); Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration (10-26 months per site); Confirmed Grade 3 or Higher Reduction in Phosphorus (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher ALT Elevation (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher AST Elevation (Through 52 weeks on product and 4 weeks post-product)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sex-Differential Health Interventions In Low-Birth-Weight Infants
Brief Summary: Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS).

Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial.

We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.


Options:
A: Mortality; Morbidity
B: Frequency of circulating Tregs expressing gut homing receptors in infant participants. (17 week post-supplementation)
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Mortality

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
Brief Summary: The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.


Options:
A: Medication Adherence (12 Months)
B: Lung function (FEV1, FVC, FEF25-75)
C: Change in lung function (48 weeks)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ketamine Improves Post-Thoracotomy Analgesia
Brief Summary: Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB) surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid antinociception and prevent opioid resistance. We hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.


Options:
A: pain score (4 hours)
B: occurrence of chronic pain (3 months)
C: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
D: The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. (April, 2007)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ketamine Improves Post-Thoracotomy Analgesia
Brief Summary: Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB) surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid antinociception and prevent opioid resistance. We hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.


Options:
A: Pain at 24 hour postoperatively (at 24 hour postoperatively)
B: Morphine consumption (12 hours)
C: pain score (4 hours)
D: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Brief Summary: Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.


Options:
A: Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). (Week 4, 12, and 24)
B: Nocturnal Sleep Length at 1 Month (1 month)
C: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
D: Pittsburgh Sleep Quality Index (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Brief Summary: In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash out period of 2 week will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.


Options:
A: Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. (7 days)
B: RP Attacks Per Day (baselin and 4 weeks)
C: The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions (6 weeeks and 12 weeks)
D: Change in the Raynaud's Condition Score (daily for 18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.


Options:
A: median overall survival (1 year)
B: Progression-free survival (5 years)
C: Overall Survival as Measured From the Day of Randomization (from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study))
D: Progression Free Survival (PFS) time (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Programs of Coordinated Care and Disease Management
Brief Summary: This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.

In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.


Options:
A: Health related quality of life (Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
B: Adherence to COPD guidelines (Twelve months post intervention)
C: Medicare program expenditures (Eight years)
D: The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Programs of Coordinated Care and Disease Management
Brief Summary: This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.

In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.


Options:
A: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
B: Cardiac Medication Use (3 and 12 months)
C: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
D: Medicare program expenditures (Eight years)

Answer: D