TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Brief Summary: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.


Options:
A: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)
B: Safety and tolerability: Adverse events, ECG, laboratory parameters (approximately 3 years); Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 (Days 3-9); Antiviral activity: HCV RNA (COBAS Taqman HCV Test) (from baseline to Day 28)
C: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
D: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes
Brief Summary: The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Albumin creatinine ratio (2-4 years treatment duration)
C: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
D: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Balance Training for People With Multiple Sclerosis
Brief Summary: People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to healthy controls. Earlier studies using core stability exercises have shown positive effects on balance, compared to no training. In Sweden, physical therapy for people with MS has often included group training. However, evidence for this intervention is scarce. The aim of this study is therefore to investigate balance training in group. The balance training includes core stability exercises and dual attention activities. A multi-centre study is planned with a waiting-list design. Participants are randomised to either exercise group with early start or with late start. The group balance training includes training 60 minutes 2 times per week for 7 weeks.


Options:
A: Fall incidence (3 months)
B: Change from Baseline in Bergs balance scale (Change from Baseline in Bergs balance scale at 7 weeks)
C: Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment (At recruitment, after treatment (5 weeks) and in the follow-up (1 month))
D: Difference in mean change in total falls between intervention and control arms (5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: Glycemic control (HbA1c).
C: To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes. (16 Weeks)
D: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
Brief Summary: The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer


Options:
A: Overall survival (Date of randomization to date of death from any cause estimated up to 2 years)
B: Overall Survival (OS) (From randomization at PD1 until death from any cause or end of study (overall approximately 35 months))
C: The primary end point was 6-month progression-free survival rate (PFS-6) (6 months)
D: Progression free survival (PFS) at 12 months (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
Brief Summary: This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.


Options:
A: Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period (Up to Week 32)
B: Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) (Baseline (Week 0) up to Week 24)
C: Patients Who Achieve 100% Reduction in Daily OCS Dose (Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)); Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg (Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.))
D: Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 (36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
Brief Summary: This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.


Options:
A: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)
B: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
C: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions (From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]))
D: Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 (36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Brief Summary: This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.


Options:
A: Number of Subjects With Overall Confirmed Objective Response (OR) (From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter)
B: Progression Free Survival (PFS) (Measured form start of treatment up to 3 years)
C: Progression free survival, PFS (This is defined as the time between date of randomisation and the first date of documented disease progression or date of death due to any cause.)
D: Overall Survival (From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: International GBS Outcome Study (IGOS): a Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).
Brief Summary: International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.


Options:
A: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
B: Guillain Barré Syndrome (GBS) disability score (1 year); MRC sum score (1 year)
C: [Safety] Expressed frequency and severity of incidence of AE/SAEs after treatment with investigational product. (6 months); [Efficacy] Proportion of subjects who reach a score of FG2 or lower on the Hughes functional grading scale at week 4（Response Rate） (4 weeks)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
Brief Summary: The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared to an attention control group.


Options:
A: Mental condition (from baseline until 6 months)
B: Health related quality of life (Change from Baseline HRQoL at 6 months)
C: Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs) (6 months)
D: The M.D. Anderson Symptom Inventory (MDASI) (Week 5 and week 11); Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 (Week 5 and week 11); Quality of Life Index (QLI) (Week 5 and week 11); Use of Unscheduled Health Service (Week 11)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (Seamos Saludables)
Brief Summary: In this study the investigators are specifically targeting Latina women because they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive interviews with Latinas in the Providence area, the investigators have modified our print-based intervention, already tested and proven to be effective in English-speaking communities, to be culturally and linguistically appropriate for the Latina community.

The objective of Seamos Saludables is to determine whether this culturally tailored print intervention will produce greater increases in physical activity levels among Latina women than a program focused on general health topics. Participants are randomly assigned to one of two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline and follow-up assessments.

The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of at least moderate intensity physical activity per week than the wellness contact control participants.


Options:
A: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)
B: ART adherence (Every 3 months up to 12 months); HIV-1 viral load (Every 3 months up to 12 months); Sexual risks (Every 3 months up to 12 months); Clinic visit adherence (Every 3 months up to 12 months)
C: Having had a pap smear in last 6 months (6 months)
D: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months (6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
Brief Summary: Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode.

The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.

The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.

Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.

Superiority in these outcomes will be evident at six months after surgery.


Options:
A: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)
B: The primary outcome of the study was the 30 day hospital readmission rate. (30 days)
C: Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT) (Pre surgery; 10 weeks, six months and twelve months after surgery.)
D: Change in HADS-A score from baseline to three months follow-up (Three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum
Brief Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.

In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.

Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).

This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).


Options:
A: Median Progression-free Survival (PFS) in each study arm (average of 18 months)
B: ORR (Up to 2 years); PFS (Up to 2 years)
C: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))
D: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum
Brief Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.

In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.

Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).

This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).


Options:
A: objective response rate by RECIST 1.1 (6 months after treatment initiation)
B: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
C: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
D: Median Progression-free Survival (PFS) in each study arm (average of 18 months)

Answer: D