TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Investigate Safety and Efficacy of Tibolone (Org OD14) in Women With Climacteric Symptoms and a History of Breast Cancer
Brief Summary: Postmenopausal women with a history of breast cancer often suffer from climacteric symptoms such as hot flushes and sweating episodes. Conventional hormone therapy is not allowed in such patients because there are indications that hormones may cause breast cancer to recur.

Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical profile that is different from conventional hormones. In contrast to conventional hormones, tibolone does not increase breast density and causes less breast pain.

The LIBERATE study is a study in which the safety and efficacy of tibolone has been investigated in postmenopausal women that have been treated for breast cancer.


Options:
A: To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. (one year)
B: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes (Baseline to End of Treatment (Week 12))
C: To show non-inferiority in breast cancer recurrence of tibolone 2.5 mg versus placebo in women with climacteric symptoms who have been surgically treated for primary breast cancer within the last 5 years (At clinical completion)
D: Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Primary Safety Endpoint: Endometrial Protection - Hyperplasia (Baseline and Month 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
Brief Summary: The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain.


Options:
A: Change in Brief Pain Inventory (BPI) 24-hour Average Rating (Baseline, Week 4, Week 7, Week 13)
B: McGill Pain Questionnaire - Short Form (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); PamSys Actigraph Data (48 hours after visit 3); Pain Anxiety Symptoms Scale (PASS) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Disability Index (PDI) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Visual Analogue Scale (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.)
C: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores (Baseline, Week 1); Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 2); Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 3); Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 4); Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 5); Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 6); Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 7); Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 8); Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 9); Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 10); Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 11); Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 12); Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 13)
D: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
Brief Summary: To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.


Options:
A: Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP (Change from baseline to final 24-hour average pain score)
B: Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score (Baseline and 12 weeks)
C: Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale (During the fourth treatment week of each treatment period)
D: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary: The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.


Options:
A: Overall survival
B: Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.)
C: Progression free survival (PFS) (2 years)
D: Progression-Free Survival (PFS) (Baseline to first observation of disease progression or death, 12 weeks up to 31 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
Brief Summary: The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.


Options:
A: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
B: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
C: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
D: Parent Report Measures (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
Brief Summary: The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.


Options:
A: Parent Report Measures (4 years)
B: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
C: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
D: ER visits (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled Study
Brief Summary: This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP).

Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.


Options:
A: Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18 (Month 18); Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18 (Baseline, Month 18)
B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation (Up to 56 days post first dose)
C: Modified Neuropathy Impairment Score +7 (mNIS+7) (18mo)
D: Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6 (Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
Brief Summary: The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.


Options:
A: Overall Survival (Up to 66 months)
B: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
C: Maximum Tolerated Dose (MTD) (28 Days)
D: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.
Brief Summary: The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.


Options:
A: The anti-MAGE-A3 seroconversion (After the fourth dose of ASCI and at the end of treatment); The anti-protein D seroconversion (After the fourth dose of ASCI and at the end of treatment); The anti-CpG seroconversion (After the fourth dose of ASCI and at the end of treatment); The MAGE-A3 cellular (T cell) response (After the fourth dose of ASCI and at the end of treatment); Occurrence of adverse events, including abnormal hematological and biochemical laboratory values (During the study); Occurrence of serious adverse events (During the study)
B: Overall Survival (Up to 66 months)
C: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs (Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years); Number of Participants With Abnormal Serum Chemistry Laboratory Values (Day 1 up to June 2013, approximately 4 years); Number of Participants With Abnormal Hematology Laboratory Values (Day 1 up to June 2013, approximately 4 years)
D: Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)); Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population (From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Brief Summary: To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.


Options:
A: Change in Body mass index percentile (24 weeks)
B: weight (6 months and 1 year); body mass index (6 months and 1 year); % body fat (6 months and 1 year); lipids (6 months and 1 year); blood pressure (6 months and 1 year); glucose (6 months and 1 year); insulin (6 months and 1 year); HOMA index (6 months and 1 year)
C: Body mass index (BMI) (Change through 2 years)
D: depressed mood (baseline, posttreatment , 6 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Brief Summary: To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.


Options:
A: Change in ambulatory activity (walking) (12 months)
B: weight (6 months and 1 year); body mass index (6 months and 1 year); % body fat (6 months and 1 year); lipids (6 months and 1 year); blood pressure (6 months and 1 year); glucose (6 months and 1 year); insulin (6 months and 1 year); HOMA index (6 months and 1 year)
C: 2-hour glucose (2 hours)
D: Change in weight from baseline (12- and 24-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Mental Health Outcomes of Child Brain Injury
Brief Summary: This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.


Options:
A: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)
B: Parent report measures (5 years); Teen self-report measures (5 years)
C: Parent Report Measures (5 years)
D: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Mental Health Outcomes of Child Brain Injury
Brief Summary: This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.


Options:
A: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)
B: Parent report measures (5 years); Teen self-report measures (5 years)
C: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
D: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
Brief Summary: The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease


Options:
A: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)
B: Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26 (Week 26)
C: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
D: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (4 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease
Brief Summary: A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.


Options:
A: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy (baseline(randomization) to 12 weeks)
B: the percent change of LDL-C level (After taken medication for 8 weeks)
C: Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12); Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12)
D: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 (Baseline and 6 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor
Brief Summary: To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.


Options:
A: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
B: 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.)
C: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))
D: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)

Answer: B