TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.


Options:
A: N/A
B: Sleep Efficiency (Post-intervention, up to 3 weeks); Sleep Minutes (post-intervention, up to 3 weeks)
C: Sleep Disturbance (Change from Baseline (week 0) and intervention (week 4)); Agitation (Change from Baseline (week 0) and intervention (week 4)); Depression (Change from Baseline (week 0) and intervention (week 4))
D: Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation (Change from baseline at 2 and 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to design a program to prevent suicide in elderly patients by educating patients, their families, and physicians on depression and suicidal thoughts.

A program to prevent suicide in elderly patients needs to be developed. Since elderly patients frequently have doctor's visits, it may be best to have a suicide prevention program based in the patient's doctor's office.

When an older person visits a primary care physician, he/she will check for signs of depression, including thoughts of suicide. The doctor will speak to the patient about depression and how to recognize it. If the individual is diagnosed with depression, the doctor will offer treatment. During this study, the information the doctor collects will be used to evaluate the effectiveness of the program. The study will last for 2 years.

Eligibility for this study is age of at least 60 years and diagnosis of depression. (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of depression.)


Options:
A: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
B: Hamilton Rating Scale for Depression (Screen, Week 9, 17, 24)
C: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to design a program to prevent suicide in elderly patients by educating patients, their families, and physicians on depression and suicidal thoughts.

A program to prevent suicide in elderly patients needs to be developed. Since elderly patients frequently have doctor's visits, it may be best to have a suicide prevention program based in the patient's doctor's office.

When an older person visits a primary care physician, he/she will check for signs of depression, including thoughts of suicide. The doctor will speak to the patient about depression and how to recognize it. If the individual is diagnosed with depression, the doctor will offer treatment. During this study, the information the doctor collects will be used to evaluate the effectiveness of the program. The study will last for 2 years.

Eligibility for this study is age of at least 60 years and diagnosis of depression. (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of depression.)


Options:
A: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
B: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)
C: Number of participants with self-reported outcome data at each time-point (6 months); Proportion of missing data in patient outcome questionnaires (6 months); Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire) (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
B: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
C: N/A
D: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe (measured at week 12 (endpoint))
B: N/A
C: Post-treatment ADHD symptoms (Post-treatment (after receiving 3 month treatment)); Post-treatment functional impairment (Post-treatment (after receiving 3 month treatment))
D: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. (change from baseline on ADHD symptoms at 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: N/A
B: SKAMP deportment rating scale (Week 8)
C: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)
D: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: N/A
B: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
C: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)
D: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimodal Treatment Study of Children With ADHD
Brief Summary: This trial is a continuation of the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA Study). Continuation Aim 1 is to track the persistence of intervention-related effects as the MTA sample matures into mid-adolescence, including subsequent mental-health and school-related service utilization patterns as a function of MTA treatment experience (treatment assignment) and outcome (degree of treatment success at 14 mo.). Aim 2 is to test specific hypotheses about predictors, mediators, and moderators of long-term outcome among children with ADHD (e.g., comorbidity; family functioning; cognitive skills; peer relations) that may influence adolescent functioning (either independent of or through initial treatment assignment and/or 14-month treatment outcomes); and to compare how these predictors, mediators, and moderators are similar or dissimilar within the normal comparison group. Aim 3 is to track the patterns of risk and protective factors (including their mediation or moderation by initial treatment assignment and/or outcome) involved in early and subsequent stages of developing substance-related disorders and antisocial behavior. Aim 4 is to examine the effect of initial treatment assignment and degree of treatment success on later academic performance, achievement, school conduct, tendency to drop out, and other adverse school outcomes.

In the original MTA design, patients were randomly assigned to 1 of 4 treatment conditions: (1) medication only; (2) psychosocial only; (3) combined (medication and psychosocial); or (4) Assessment-and-Referral condition. All but the latter were treated intensively for 14 months, with assessments for all subjects at baseline, 3, 9, 14, and 24 months. The original MTA design thus provides short-term (10 months post-treatment) follow-up at 24 months. This continuation extends the follow-up to assessments at 36, 60, and 84 months after treatment.

A child may be eligible for this study if he/she:

Is 7 - 9 years old, and has Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Wender Reimherr Adult Attention Deficit Disorder Scale (Double-blind endpoints during MTS and placebo arms)
B: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
C: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.
Brief Summary: This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain.

In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.


Options:
A: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
B: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
C: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
D: Number of Subjects With Improvement of at Least 15 Points in ODI (5 years); Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation (5 years); Number of Subjects With no Major Device Related Complications (5 years); Number of Subjects With no Epidural Injection(s) (5 years); Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit (5 years); Number of Subjects With no Persistent New or Increasing Sensory Deficit (5 years); Number of Subjects With no Persistent New or Increasing Motor Deficit (5 years); Number of Subjects With no Reoperations or Epidural (Up to Day 1825) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Degenerative Spondylolisthesis (DS) With Spinal Stenosis (SpS) at L4/L5 Level.
Brief Summary: This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain.

In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.


Options:
A: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
B: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
C: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
D: Mean Change in VAS (Baseline and 6 weeks prior to cross-over); Mean Change in ODI (Baseline and 6 weeks prior to cross-over); Mean Change in VAS (Baseline and 26 weeks After ESI to mild cross-over); Mean Change in ODI (Baseline and 26 weeks After ESI to mild cross-over)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)
Brief Summary: This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. Low back pain is one of the most widely experienced health problems in the United States and the world. It is the second most frequent condition, after the common cold, for which people see a doctor or lose days from work.

In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) with a type of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This study does not cover the cost of treatment.


Options:
A: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
B: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
C: Oswestry Disability Index (ODI) (2 years)
D: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)

Answer: B