TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons
Brief Summary: The purpose of this trial is to study the safety, tolerability and efficacy of an almond enriched hypocaloric diet on weight loss and weight maintenance, as well as on established and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.


Options:
A: Changes from baseline in circulating levels of glucose and insulin according to the intervention arm (Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
B: Change in Weight (2, 4, 6, 8, 10, and 12 weeks); Change in Blood Lipids (4, 8, and 12 weeks); Change in Blood Pressure (2, 4, 6, 8, 10, and 12 weeks); Change in Hedonics of peanut consumption (12 weeks); Change in Body Composition (2, 4, 6, 8, 10, and 12 weeks); Change in Fasting Blood Glucose (4, 8, and 12 weeks); Change in Cortisol (4, 8, and 12 weeks); Change in Insulin (4, 8, and 12 weeks); Change in Pulse (2, 4, 6, 8, 10, and 12 weeks)
C: To evaluate the effects of an almond-enriched (2 oz/day) hypocaloric, low-fat diet on body weight and body composition in overweight and obese persons (6 months)
D: Metabolic syndrome status (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychosocial/Behavioral Intervention in PSD
Brief Summary: The primary aim of this study is to determine the effect of a nurse-delivered psychosocial/behavioral intervention on reduction of depression in community dwelling post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be more effective than pharmacotherapy alone in sustaining the improvement in depression for the experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral intervention time course and sustainability of response to treatment, effect on limitations in ability, limitation in participation and overall stroke impact in community-dwelling post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).


Options:
A: Feasibility of recruitment (ability to recruit dyads) (Baseline); Feasibility of intervention delivery (ability to deliver intervention to dyads) (Feasibility of program delivery will be measured at 6 weeks); Credibility and expectancy questionnaire (Baseline); Client Satisfaction Questionnaire (post intervention (6 weeks after baseline))
B: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
C: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. (12 months following stroke)
D: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychosocial/Behavioral Intervention in PSD
Brief Summary: The primary aim of this study is to determine the effect of a nurse-delivered psychosocial/behavioral intervention on reduction of depression in community dwelling post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be more effective than pharmacotherapy alone in sustaining the improvement in depression for the experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral intervention time course and sustainability of response to treatment, effect on limitations in ability, limitation in participation and overall stroke impact in community-dwelling post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).


Options:
A: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))
B: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. (12 months following stroke)
C: Occurrence rate of depression (3 months)
D: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Brief Summary: This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Hemoglobin A1c
C: Rate of Change in Hemoglobin A1c (12 month period)
D: Changes in HbA1c (Baseline, 16 weeks, 32 weeks, 6 months after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Brief Summary: This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.


Options:
A: Hemoglobin A1c
B: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)
C: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Brief Summary: This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.


Options:
A: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
B: Hemoglobin A1c
C: Hemoglobin A1c (HbA1c)
D: HBA1c Glycosylated hemoglobin (one year for every patient)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Brief Summary: This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.


Options:
A: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
B: Change in Patient Activation Measure (Admission to Unit and 3-5 days after)
C: Hemoglobin A1c
D: The primary study endpoint is 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
Brief Summary: The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 \>250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive.

Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count \>250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed.

The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.


Options:
A: HIV acquisition; safety of circumcision
B: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
C: Sequence-verified HIV-transmission from index to partner participant (March 2009)
D: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
Brief Summary: The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 \>250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive.

Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count \>250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed.

The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: pregnancy
C: Contraceptive use at time of last sexual intercourse (18 months)
D: Sequence-verified HIV-transmission from index to partner participant (March 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
Brief Summary: The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 \>250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive.

Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count \>250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed.

The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.


Options:
A: Unintended pregnancies (24 months)
B: HIV sero-incidence (24 months post-baseline)
C: Sequence-verified HIV-transmission from index to partner participant (March 2009)
D: Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions (10 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: American College of Rheumatology 20 Response (ACR20) (12 weeks)
B: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
C: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Percentage of patients with ACR 20 response (Week 24)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
C: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
D: ACR 20% response (Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS) (Days 71 to 85); Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE) (Day 85 to 56 days post last dose); Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE) (Day 85 to Day 533); Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing) (Day 533 to 56 Days Post last dose)
B: Proportion of patients with an ACR20 response (24 weeks)
C: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
C: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary: To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
D: ACR 20% response (Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).
Brief Summary: The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.


Options:
A: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
B: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
C: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
D: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).
Brief Summary: The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.


Options:
A: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
C: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
D: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)

Answer: C