TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: ARBITER 6: ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis (HALTS)
Brief Summary: Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines, low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first evidence of the potential of raising HDL-C with extended release niacin when added to statin monotherapy. However, whether this approach would be superior to a strategy in which lower concentrations of LDL-C are targeted is unknown.

The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid treatments for their effects of atherosclerosis. This study is a prospective, randomized, open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through the presence of a coronary risk equivalent who are currently being treated with a statin will be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement.

The effects of these 2 different strategies of intensified lipid management on atherosclerosis will be assessed by the change in the carotid intima-media thickness, a validated surrogate endpoint. The data will help guide clinicians on the potential benefits of these lipid treatment strategies.


Options:
A: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline and Week 12); Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (Baseline and Weeks 10 and 12)
B: Change from baseline in low density lipoprotein cholesterol after 12 weeks
C: Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment. (after 12 weeks of treatment)
D: The primary endpoint is the change in carotid intima-media thickness between groups after 14 months (14 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ARBITER 6: ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis (HALTS)
Brief Summary: Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL (revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines, low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first evidence of the potential of raising HDL-C with extended release niacin when added to statin monotherapy. However, whether this approach would be superior to a strategy in which lower concentrations of LDL-C are targeted is unknown.

The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid treatments for their effects of atherosclerosis. This study is a prospective, randomized, open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through the presence of a coronary risk equivalent who are currently being treated with a statin will be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement.

The effects of these 2 different strategies of intensified lipid management on atherosclerosis will be assessed by the change in the carotid intima-media thickness, a validated surrogate endpoint. The data will help guide clinicians on the potential benefits of these lipid treatment strategies.


Options:
A: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
B: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
C: N/A
D: The primary endpoint is the change in carotid intima-media thickness between groups after 14 months (14 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.
Brief Summary: The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.


Options:
A: Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children (Through to week 96); Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children (Through to week 96)
B: to compare the compliance; to compare the side effects
C: TB incidence (Jan 2003 to July 2011); Mortality (Jan 2003 to July 2011)
D: Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) (6/2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Brief Summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Options:
A: Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up (Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks))
B: change in body weight (6 weeks)
C: Fatigue (immediately before and after the intervention)
D: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Brief Summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Brief Summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Options:
A: 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)
B: Fatigue (immediately before and after the intervention)
C: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
D: Quality of life (Participants will be followed over 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Brief Summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Options:
A: Gain in range of movement measured in degrees (Three months)
B: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
C: Fatigue (immediately before and after the intervention)
D: change in physical activity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial
Brief Summary: The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Options:
A: Fatigue (immediately before and after the intervention)
B: BMI (Baseline, 4 months)
C: Accelerometer, average counts of dynamic acceleration (physical activity) (1 week at baseline and at 12 months)
D: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Cleft Prevention Program
Brief Summary: The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.


Options:
A: Recurrence of cleft lip and palate (3 months)
B: ongoing pregnancy on the 20th week of gestational age (20th week of gestational age)
C: Incidence of preeclampsia
D: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Cleft Prevention Program
Brief Summary: The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.


Options:
A: Peripheral parasitemia; Hemoglobin level
B: Recurrence of cleft lip and palate (3 months)
C: Birth weight; 3-month infant mortality
D: Anemia (6 months following the start of the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga for Persistent Sleep Disturbance in Cancer Survivors
Brief Summary: RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.


Options:
A: 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)
B: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)
C: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
D: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) (2-24 months after surgery, chemotherapy, and/or radiation therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Surveillance for Colorectal Polyps
Brief Summary: RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.

PURPOSE: This randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.


Options:
A: Successful completion of follow-up colonoscopy; Number of patients completing colonoscopy during the study period
B: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
C: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
D: Computed tomography ordering proportions (January 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks (4 Weeks)
B: Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30 (From baseline to day 30)
C: Roland Morris Disability Questionnaire (change from baseline to 3 months)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
D: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Resolution or improvement in screened chronic condition; Improved communication with primary care doctor; Improved patient satisfaction; Improved physician satisfaction
B: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
C: IBS Symptom Severity Score (Baseline, 6 and 12 weeks); IBS QOL (Baseline, 6 and 12 weeks)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Knee function, as measured by the ERGOS machine (Measured at baseline and Months 9 and 24)
B: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
C: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
B: reduction number of tender points (paired) (one year treatment)
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: D