TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. A bone marrow transplant, using bone marrow from the patient, may be able to replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which combination chemotherapy schedule is more effective, when given before surgery and an autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.

PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to compare how well they work in treating young patients who are undergoing surgery and an autologous bone marrow transplant for disseminated neuroblastoma.


Options:
A: N/A
B: N/A
C: Event-Free Survival (EFS) (Three years)
D: Event-free survival rate (Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years); Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy (Up to day 42)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
Brief Summary: To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE


Options:
A: The main efficacy outcome is objectively confirmed recurrent thromboembolism from randomization up to completion of 33 months of follow-up. (33 months)
B: Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up; Confirmed major bleeding events at 18 months follow up
C: Death due to DVT/PE; Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.; Number of major haemorrhages.
D: Recurrent Venous Thromboembolism; major and minor haemorrhage; death

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinician Integration Study
Brief Summary: The purpose of this study is to find out if patients with lung cancer and their main informal caregiver (person providing physical, emotional, or financial support) are helped by getting information, support, and decision making tools through a computer system called CHESS(the Comprehensive Health Enhancement Support System)


Options:
A: Change in the mean score of distress (Hospital Anxiety Depression Scale) (Baseline, after 3, 6 and 9 months); Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey) (Baseline, after, 3, 6 and 9 months)
B: Change in Impact of Event Scale (IES) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Hospital Anxiety and Depression Scale (HADS) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Profile of Mood States - Short Form (POMS-SF) (Baseline, 2 weeks post-intervention, 10 months follow-up)
C: PROMIS Physical Functioning (6 months); PROMIS Satisfaction With Social Roles (6 months); PROMIS Anxiety (6 months); PROMIS Depression (6 months); PROMIS Fatigue (6 months)
D: Caregiver affect and adjustment (1 year post patient death)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain
Brief Summary: The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.


Options:
A: Mean Subjective Sleep Diary Derived Total Sleep Time (TST) (Postnaprosyn baseline, Week 1, week 2, week 4)
B: mean subjective SL (Week 1)
C: Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). (Baseline (Day 0) to Week 12)
D: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
Brief Summary: To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.


Options:
A: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))
B: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
C: TST (6 weeks)
D: mean subjective SL (Week 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
Brief Summary: There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).


Options:
A: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. (Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.)
B: weight gain in childhood tuberculosis (2 months after start of anti-tuberculosis therapy.)
C: Time to sputum culture conversion (8 weeks of treatment)
D: The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative (Up to 16 weeks from therapy start date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Brief Summary: Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Options:
A: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
B: The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period. (4 and 7 days)
C: Time to repeat therapeutic paracentesis (12 weeks)
D: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Deep Brain Stimulation for Treatment Resistant Depression
Brief Summary: The purpose of this study is to test the safety, efficacy and mechanism of action of subgenual cingulate (Cg25) deep brain stimulation (DBS) for major depression in patients who have not responded to prior antidepressant treatments. Participation in the study will continue for ten years or until the device receives FDA approval for depression. Forty (40) patients will be enrolled in this study.


Options:
A: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
B: Change in Hamilton Depression Rating Scale-17 Score (Baseline, Week 24 post-intervention)
C: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)
D: Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation (6 months after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Brief Summary: The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:

1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).

The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.

Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.


Options:
A: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)
B: Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years. (Baseline to 2 Years); Median Change in Visual Acuity Baseline to 2 Years (Baseline to 2 Years); Distribution of Change in Visual Acuity Baseline to 2 Years (baseline to 2 years)
C: Visual Acuity (36 months)
D: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
Brief Summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.


Options:
A: Time to progression; Response rate
B: response rate (12 months)
C: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
D: Overall survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protein Supplementation in Dialysis Patients
Brief Summary: The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.


Options:
A: Change in serum albumin (16 weeks)
B: Blood glucose response curve (3 hour)
C: net muscle protein balance (10 hours)
D: Mortality (Intervention discontinued on April 13, 2020 due to Covid-related prohibition on eating in facilities. Event follow-up concluded on August 13, 2020. Follow-up time varied among participants, with the maximum of approximately 3.5 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active Psoriatic Arthritis
Brief Summary: This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.


Options:
A: Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16 (between baseline and week 16)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results (Week 0 through Week 8)
D: Proportion of patients achieving an ACR20 response. (48 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Intervention for Problem Drinking
Brief Summary: The main aim of this randomized controlled trial is to evaluate the efficacy of an Internet-delivered self-help intervention for problem drinkers in the general population.

Adult problem drinkers with home access to the Internet will be recruited from the CAMH Monitor. Subjects will be randomly assigned to receive a website address where they can obtain personalized feedback about their drinking, or to a no intervention control group.

Three-month and six-month follow-up surveys will be conducted by mail to assess drinking over the following three month periods. Collaterals will be requested and interviewed after the six-month follow-up. Subjects will be paid $40.00 and collaterals will be paid $20.00 for their participation. Drinking at three- and six-months will be compared between the groups. Subjects in the control group will be provided with the website address following the six-month follow-up.


Options:
A: Change in estimated Blood Alcohol Concentration (eBAC) (6, 12 and 18 weeks); Alcohol Use Disorders Identification Test (AUDIT) (6, 12 and 18 weeks)
B: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
C: frequency of consumption; drinks per occasion; number of drinks in a typical week; frequency of 5+ consumption; highest number of drinks on one occasion.
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Brief Summary: To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).


Options:
A: Latency to persistent sleep measured by polysomnography (4 weeks)
B: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
C: mean subjective wake time after sleep onset (WASO) (Week 1)
D: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Refractory Symptoms in Primary Care (Hypochondriasis: Diagnosis, Description and Medical Care)
Brief Summary: This study will evaluate the effectiveness of an integrated three-part treatment program in improving the quality of care and treatment outcomes of people with hypochondriasis in primary care settings.


Options:
A: General Self-Efficacy Scale (GSE) (Baseline, 8 Weeks, 12 Months)
B: Whitely Index (Measured immediately post-treatment and at Months 6 and 12 post-treatment)
C: Perceived quality of life (Change from baseline in quality of life at 12 months after the intervention)
D: Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality) (Measured at baseline and months 4 (end of treatment), 10 and 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension
Brief Summary: Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.


Options:
A: To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. (after 4 weeks of treatment)
B: Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 (Baseline and Week 12)
C: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study (Baseline - end of study (Week 52 or Last observation carried forward (LOCF))
D: Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effective Treatment for Dually Diagnosed Homeless
Brief Summary: This randomized controlled trial examined whether an abbreviated treatment using abstinence contingency management for housing and work/training (CM, n=103) with cocaine dependent, non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared to the full treatment (CM+, n=103). It was hypothesized that CM+ would show superior abstinence and retention outcomes, but that CM, with components derived from previously effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or more of those observed for the full treatment (CM+) during active treatment months 1-6. The CM+ included all CM components but added behavioral day treatment that included voucher reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five domains of functioning: drug dependence, homelessness, unemployment, non-drug related recreational activities, and behavioral, health, or mental health problems. Abstinence was assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly, bi-monthly for months 13-18. Abstinence, homelessness, employment and other outcomes were also assessed at baseline, 2, 6, 12, and 18 months.


Options:
A: Addiction Severity Index Alcohol Composite (Baseline, end of treatment (month 3), 3-month post-treatment follow-up); Addiction Severity Index Drug Composite (Baseline, end of treatment (3 months), and 3-month post-treatment followup); Brief Addiction Monitor (Baseline, end of treatment (month 3), 3-month post-treatment follow-up)
B: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
C: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
D: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effective Treatment for Dually Diagnosed Homeless
Brief Summary: This randomized controlled trial examined whether an abbreviated treatment using abstinence contingency management for housing and work/training (CM, n=103) with cocaine dependent, non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared to the full treatment (CM+, n=103). It was hypothesized that CM+ would show superior abstinence and retention outcomes, but that CM, with components derived from previously effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or more of those observed for the full treatment (CM+) during active treatment months 1-6. The CM+ included all CM components but added behavioral day treatment that included voucher reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five domains of functioning: drug dependence, homelessness, unemployment, non-drug related recreational activities, and behavioral, health, or mental health problems. Abstinence was assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly, bi-monthly for months 13-18. Abstinence, homelessness, employment and other outcomes were also assessed at baseline, 2, 6, 12, and 18 months.


Options:
A: N/A
B: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
C: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
D: reduction in drug use (8 weeks)

Answer: C