TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES)
Brief Summary: The Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project is an after-school program that includes weight loading physical activity, nutrition and bone health education, and calcium-rich snacks. The program is designed to improve bone health in early elementary school children.


Options:
A: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
B: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed.

This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.


Options:
A: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
B: N/A
C: Mean monthly number of headache days with moderate or severe intensity (3 months)
D: frequency of migraine attacks (16th week after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma
Brief Summary: Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.


Options:
A: Overall Survival (Event-driven timeframe. Final analysis at 331 events.)
B: Disease specific mortality (Median 15 years follow up)
C: Overall survival (1:Not applicable)
D: Overall Survival (During study period (up to 3 years)); Radiographic Progression-free Survival (rPFS) (During study period (up to 20 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief Summary: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Options:
A: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
B: Overall Survival (OS) (Baseline up to Month 80)
C: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
D: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief Summary: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Options:
A: N/A
B: Overall Survival (OS) (Baseline up to Month 80)
C: Progression-free Survival (Randomization until progression (up to 2 years))
D: Overall survival (2015 (estimated))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief Summary: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Options:
A: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
B: Progression-Free Survival (PFS) (From initiation of treatment up to follow-up period (up to 3 years))
C: Overall Survival (OS) (Baseline up to Month 80)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief Summary: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Options:
A: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
B: Overall Survival (OS) (Baseline up to Month 80)
C: Safety parameters (From signing consent to 30 days after last dose of study drug)
D: Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Acupuncture for Chronic Low Back Pain
Brief Summary: This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.


Options:
A: Pain intensity over 8 weeks (area under the curve) (8 weeks)
B: N/A
C: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
D: 11-point Short Pain Scale (SPS-11) (20 minute)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Acupuncture for Chronic Low Back Pain
Brief Summary: This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.


Options:
A: Safety (local and systemic reactogenicity, lab tests, AEs)
B: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
C: Proportion of enrolled patients who attend for their assigned screening test (Immediate)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Test the Safety and Efficacy of Lipitor (Atorvastatin) in Reducing the Progression of Carotid IMT in Early Childhood SLE
Brief Summary: The purpose of this study is:

1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood.
2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin.
3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively.
4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).


Options:
A: Myopathy frequency (Measured every other week); Arm isokinetic force at 60 degrees per second (Measured at Month 6); Leg isokinetic force at 60 degrees per second (Measured at Month 6); Handgrip isometric force (Measured at Month 6); Leg dynamic endurance (Measured at Month 6); Maximal aerobic power (Measured at Month 6)
B: This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.; Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.; Determine whether atorvastatin 40 mg is more effective than placebo in preventing new or preventing progression of old atherosclerotic plaque on carotid duplex over two years.; Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.
C: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
D: Change in Mean-Mean Common Carotid IMT (CIMT) (Change from baseline to 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Brief Summary: Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.


Options:
A: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (4 years)
B: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
C: Stress urinary continence (3 months)
D: Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Joint Attention Intervention With Caregivers and Their Children With Autism
Brief Summary: Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.


Options:
A: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)
B: N/A
C: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
D: Social network involvement of autistic children (Measured before and after treatment and at 3-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Joint Attention Intervention With Caregivers and Their Children With Autism
Brief Summary: Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.


Options:
A: childrens score on measures of joint attention (pre, post, follow up 6 months and 1 year)
B: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
C: N/A
D: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures (Measured at Year 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multisite Controlled Secretin Trial in Autism
Brief Summary: Many drugs used to treat autism target specific symptoms, such as hyperactivity and aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction and communication. This study will evaluate two forms of the drug secretin for the treatment of core autistic symptoms.


Options:
A: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
B: N/A
C: Clinical Global Impression -- Improvement (CGI-I) Scale (Weekly for 4 weeks, then monthly, with 16-week end point. Primary outcome assessment used two time points, baseline and 16 weeks.); Clinical Global Impression -- Severity (CGI-S) Scale (Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multisite Controlled Secretin Trial in Autism
Brief Summary: Many drugs used to treat autism target specific symptoms, such as hyperactivity and aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction and communication. This study will evaluate two forms of the drug secretin for the treatment of core autistic symptoms.


Options:
A: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
B: Number of participants tranquil or alseep at four hours after the intevention
C: N/A
D: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multisite Controlled Secretin Trial in Autism
Brief Summary: Many drugs used to treat autism target specific symptoms, such as hyperactivity and aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction and communication. This study will evaluate two forms of the drug secretin for the treatment of core autistic symptoms.


Options:
A: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
B: N/A
C: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
D: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-Dose Doxycycline Effects on Osteopenic Bone Loss
Brief Summary: The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient).


Options:
A: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
B: Alveolar Bone Density (Baseline, one-year and two-year visits)
C: Changes in C reactive protein (Baseline, 3, 6 and 12 months); Changes in flow-mediated dilation (Baseline, 1, 3 and 6 months)
D: Brachial Artery Flow-mediated Dilation (Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Brief Summary: The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets \>= 4 mm.


Options:
A: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
B: Change in Mean Clinical Attachment Level. (Baseline, 3, 6 and 12 months)
C: Change in Clinical Attachment Level (CAL) (Baseline, 3 and 6 months)
D: Clinical Attachment Level (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Brief Summary: The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets \>= 4 mm.


Options:
A: Probing Depth (six months period (two measurements))
B: Change in Mean Clinical Attachment Level. (Baseline, 3, 6 and 12 months)
C: probing depth (six months)
D: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Periodontal Therapy on Preterm Birth
Brief Summary: The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).


Options:
A: Birth at less than 37 weeks gestational age (37 weeks gestational age)
B: Gestational age at birth (At delivery)
C: Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks (9 months)
D: Rate of pre-term birth

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
Brief Summary: This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.


Options:
A: N/A
B: N/A
C: Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.; Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.
D: Change From Baseline in Bone Mineral Density (baseline and 2 years)

Answer: A