TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Brief Summary: To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.


Options:
A: Change in the spherical equivalent refractive error relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Change in axial length relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Measurement of corneal curvature (keratometry)relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months)
B: Progression of myopia, determined by cycloplegic autorefraction
C: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)
D: the change in spherical equivalent (SE) (SE measured at 3, 6, 9, 12 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
Brief Summary: The investigators plan to evaluate, in a randomized, controlled phase III trial in patients with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise intervention program (EIP) on quality of life, physical functioning and immune function parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases, Heidelberg, over a time period of two years and followed up for a total of 12 months.

Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential influence of social contacts that can be anticipated for the patients in the intervention group).

Our primary aims are to investigate whether a combination of a partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life (QoL) and lowers levels of fatigue (evaluation via the standardized and validated questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on tumor specific immune responses. Biomarkers of immune function will be measured by cellular immunity and cytokine and chemokine panels.

Further secondary outcomes include measurement of anxiety, depression and demoralization, physical performance parameters (e.g. improvement in walk distance, muscle strength), as well as overall and progression free survival analyses.

The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in patients with advanced NSCLC with the results being utilized in the design of the here proposed trial.

The investigators hypothesize that patients randomized in the exercise intervention group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.


Options:
A: Systemic inflammation measured by c-reactive protein. (12 weeks)
B: Change in inspiratory muscle strength (Before surgery, 5.postoperative day, 2 weeks after surgery)
C: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)
D: Fatigue (immediately before and after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise Program in Lung Cancer Patients With Non-operable Disease Undergoing Palliative Treatment
Brief Summary: The investigators plan to evaluate, in a randomized, controlled phase III trial in patients with advanced non-small cell lung cancer (NSCLC), the effects of a 24-week exercise intervention program (EIP) on quality of life, physical functioning and immune function parameters. Eligible patients (n=250) will be enrolled in the Clinic for Thoracic Diseases, Heidelberg, over a time period of two years and followed up for a total of 12 months.

Patients will be randomized either to EIP plus Care Management Phone Calls (CMPC) versus CMPC alone (besides a proper symptom and side effect management CMPC ensures the potential influence of social contacts that can be anticipated for the patients in the intervention group).

Our primary aims are to investigate whether a combination of a partly supervised (in- and outpatient) and partly home-based endurance and resistance training improves quality of life (QoL) and lowers levels of fatigue (evaluation via the standardized and validated questionnaires FACT-L and MFI). In addition we propose to evaluate the effects of EIP on tumor specific immune responses. Biomarkers of immune function will be measured by cellular immunity and cytokine and chemokine panels.

Further secondary outcomes include measurement of anxiety, depression and demoralization, physical performance parameters (e.g. improvement in walk distance, muscle strength), as well as overall and progression free survival analyses.

The study builds on a previous feasibility study of a 8 weeks exercise intervention trial in patients with advanced NSCLC with the results being utilized in the design of the here proposed trial.

The investigators hypothesize that patients randomized in the exercise intervention group will show improved QoL and reduced fatigue, as well as improved physical functioning and increased tumor specific immune responses.


Options:
A: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
B: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)
C: Stroop Test (Change from baseline at 6 months)
D: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase Ib and Randomised Phase II Trial of Pazopanib With or Without Fosbretabulin in Advanced Recurrent Ovarian Cancer
Brief Summary: The first part of this study is to find the recommended dosages of a combination of two drugs: pazopanib and fosbretabulin, which will be given to female patients with relapsed ovarian cancer.

The second part of the study involves comparing the recommended dose of pazopanib and fosbretabulin in combination against pazopanib alone in female patients with relapsed ovarian cancer to determine whether the combination is more beneficial that pazopanib on it's own.


Options:
A: Phase Ib: Dose Limiting Toxicities of Dose of Pazopanib and Fosbretabulin (4 weeks after starting treatment (1 cycle)); Phase II: Progressive disease (Progressive disease (average of 4 months from start of treatment) measured by RECIST)
B: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
C: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
D: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormones and Physical Exercise (HOPE) Study
Brief Summary: The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.


Options:
A: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))
B: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
C: Patient rated physical functioning (at 8 weeks and 24 weeks)
D: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormones and Physical Exercise (HOPE) Study
Brief Summary: The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.


Options:
A: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
B: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
C: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
D: Fatigue (immediately before and after the intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormones and Physical Exercise (HOPE) Study
Brief Summary: The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.


Options:
A: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
B: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
C: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
D: Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormones and Physical Exercise (HOPE) Study
Brief Summary: The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.


Options:
A: Bone mass-lumbar spine and hip (DEXA) (baseline, 12 months)
B: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
C: Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention. (Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.); Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors. (Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.)
D: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Brief Summary: Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients.

When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit.

This clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It addresses the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life?

The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes


Options:
A: Change in Patient Quality of Life at Baseline and 8 Months (Baseline and 8 months)
B: Change in Shoulder Rating Questionnaire (SRQ) score from baseline (Baseline (0 weeks) and post-intervention (17 weeks)); Change in brain activity related to central motor control from baseline (Baseline (0 weeks) and post-intervention (17 weeks))
C: Weekly minutes spent in aerobic and strengthening activity (Baseline, 12, 26 and 52 weeks)
D: DM1-Activ (Baseline and 10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Brief Summary: Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients.

When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit.

This clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It addresses the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life?

The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes


Options:
A: Change in Patient Quality of Life at Baseline and 8 Months (Baseline and 8 months)
B: Rates of participant completion of >2 symptom reports (2 years)
C: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
D: Change in the Patient Safety Climate Synthetic Index (At pre-intervention and after 12 months follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening and Brief Intervention in the ED Among Mexican-origin Young Adults
Brief Summary: The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a motivational intervention delivered by a Health Promotion Advocate, relative to standard care with and without assessment, on a reduction in heavy drinking and alcohol-related problems in the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are related to effectiveness of the intervention and that predict successful treatment outcome. Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The specific hypotheses to be examined in this proposal are: 1) the motivational interview will lead to significantly greater reductions in the maximum number of drinks on an occasion and in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard care without assessment (those who screen positive but are not assessed) as well as compared to standard care with assessment; 2) the motivational interview will lead to significantly greater reductions in number of drinking days per week, average number of drinks per day, maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported drinking prior to the event resulting in the ED visit will be positively predictive of effectiveness of the intervention; 4) attributing a causal association of drinking and the reason for the ED visit will be positively associated with effectiveness of brief intervention; 5) readiness to change (and stage of change) will be positively associated with effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking dispositions will be negatively associated with effectiveness of brief intervention.


Options:
A: Change in the number of drinks per week and the number of drinks per drinking day (Baseline, 3 months & 12 months)
B: N/A
C: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)
D: Drinks per drinking day (6 months); Rate of effective contraception (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Preterm Birth With a Pessary in Singleton Gestations
Brief Summary: Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.


Options:
A: Preterm delivery before 37 weeks (2 years)
B: Proportion of spontaneous preterm birth before 34 weeks of gestation (up to 11 weeks (from date of randomization until delivery))
C: preterm birth before 34 weeks of gestation rate in singleton pregnancies (up to 20 weeks from recruitment); preterm birth before 32 weeks of gestation rate in twin pregnancies (up to 20 weeks from recruitment)
D: Number of Subjects Experiencing Preterm Birth (Before 37 weeks gestation (20 0/7 - 36 6/7 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Human Thalamocortical Network in Tourette Syndrome
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of deep brain stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).

This investigation will (1) test the hypothesis that centromedian (CM) continuous brain stimulation will be an effective, safe method for the treatment of tics in medication refractory TS, (2) will define the intra-operative and post-operative physiological changes, and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an alternative to chronic DBS in TS.


Options:
A: Severity of tics
B: Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score (baseline to 24 months); Levodopa Equivalents, Change From Baseline (baseline to 24 months)
C: Number of Participants With a 40% Reduction in Total Tics on the Yale Global Tic Severity Scale (YGTSS) With CDBS (Period 1) (Baseline to 6 months post-surgery)
D: Change in Yale Global Tic Severity Scale (Three months after stimulation switched ON v three months after stimulation switched OFF)

Answer: C