TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics
Brief Summary: To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan


Options:
A: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
B: Time to first severe asthma exacerbation
C: Comparison of FEV1 (Forced expiratory volume in the first second) values. (8 weeks)
D: Mean percentage of symptom-free days over a 52-week treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
Brief Summary: This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Primary Outcome Measure:

• Progression free survival (PFS)

Secondary Outcome Measures:

* Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
* Safety and Tolerability
* Change and duration of change on blood levels of CA-125


Options:
A: Complete response rate (average 24 months)
B: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
C: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator (Up to ~38 months)
D: Progression Free Survival (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
Brief Summary: This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Primary Outcome Measure:

• Progression free survival (PFS)

Secondary Outcome Measures:

* Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
* Safety and Tolerability
* Change and duration of change on blood levels of CA-125


Options:
A: Progression-free Survival (PFS) (From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months))
B: Progression free survival (PFS) (4 months)
C: Progression-free Survival(PFS) (up to 2 years)
D: Progression Free Survival (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
Brief Summary: This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Primary Outcome Measure:

• Progression free survival (PFS)

Secondary Outcome Measures:

* Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
* Safety and Tolerability
* Change and duration of change on blood levels of CA-125


Options:
A: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
B: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
C: Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） (At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy)
D: Progression Free Survival (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia
Brief Summary: The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.


Options:
A: Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (Baseline, 6 months, 12 months)
B: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
C: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
D: Cognition measured according to ADAS-cog, MMSE scales

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia
Brief Summary: The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.


Options:
A: Nutritional status; Quality of life; Physical performance
B: Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (Baseline, 6 months, 12 months)
C: cognitive decline (33 months)
D: mean dietary intake of inpatients during a 24 hour period (end of year 1 and year 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
Brief Summary: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: 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))
B: Percentage of Participants Who Died: PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); Overall Survival (OS): PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); OS: TC1/2/3 or IC1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); OS: SP-ITT (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC1/2/3 Or IC1/2/3 Subgroup of SP (Baseline until death from any cause (approximately 2.87 years)); OS: TC2/3 or IC2/3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC3 or IC3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years))
C: Maximum Tolerated Dose (MTD) (28 Days)
D: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
Brief Summary: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
B: 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)
C: 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))
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Post- War Adjustment in Bosnian Adolescents, Their Parents and Teachers
Brief Summary: Context: This is the first multi-site randomized controlled study of the effectiveness of a group treatment for war-exposed adolescents delivered in-country within a public school system.

Objective: To evaluate the effectiveness of a trauma/grief-focused group treatment program in reducing symptoms of posttraumatic stress disorder (PTSD), depression, and traumatic grief in war-exposed Bosnian youths attending 10 secondary schools located in Central Bosnia.


Options:
A: UCLA PTSD Reaction Index (Pre-treatment, post-treatment, and at 4-month follow-up); Depression Self-Rating Scale (Pre-treatment, post-treatment, and 4-month follow-up); UCLA Grief Scale (Pre-treatment, post-treatment)
B: Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (Immediately post-intervention and 6-months post intervention)
C: Feasibility of the Coping Coach Online Intervention (6 weeks); Mean Time Spent Using the Intervention (6 weeks)
D: Change in adolescent mental health symptoms (baseline, 4 month followup, and 12 month followup); Change in parent mental health symptoms (baseline, 4 month followup, 12 month followup); Change in parent-child conflict (baseline, 4 month followup, 12 month followup); Change in parent-child relationship quality (baseline, 4 month followup, 12 month followup)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Asymptomatic Volunteers Who Are Infected With Either Mycobacterium Tuberculosis (M.tb.), Human Immunodeficiency Virus (HIV) or Both
Brief Summary: This study is designed to evaluate the safety of MVA85A in asymptomatic volunteers in South Africa who are infected with M.tb, HIV or both. A single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, is safe and highly immunogenic in mycobacterially naïve individuals, BCG vaccinated individuals and M.tb latently infected individuals. We will use the same vaccination regime in this study. Participants will be defined as being infected with M.tb.if they have a positive Elispot response to ESAT6 or CFP10. Participants will be defined as being infected with HIV.if they have a positive HIV rapid test (Determine®, Abbott Laboratories) followed by a positive HIV ELISA result. Participants will be identified from the general population living in Worcester, Western Cape, South Africa


Options:
A: The induction of T-cell responses (6 months)
B: To assess the safety of a single intradermal injection of 5 x 107p.f.u. MVA85A. (One year)
C: Culture and RT-PCR quantification of BCG in challenge site biopsy (10 weeks post biopsy)
D: Safety (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Immunogenicity of M. Bovis BCG (SSI Strain), Delivered Intradermally in Healthy Volunteers
Brief Summary: To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.


Options:
A: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)
B: Safety of MVA85A (Six months)
C: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. (AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.)
D: The induction of T-cell responses (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Randomized, and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
Brief Summary: In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer.

However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.


Options:
A: N/A
B: HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml. (two months after the last injection;week 28, month 18, month 30 and month 42)
C: Sero-response to Hepatitis B Surface Antigen (Week 28)
D: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen (Week (Wk) 28 (One month after the second immunization)); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) (Week 12, Week 24, Week 28, Week 76); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) (Week 12, Week 24, Week 28, Week 76)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
Brief Summary: The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.


Options:
A: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
B: Age (4 weeks); Gender (4 weeks); Educational level (4 weeks); Cognitive status- Screening (4 weeks); Severe cognitive status- Screening (4 weeks); Cognitive status- Level (4 weeks); Cognitive domains (4 weeks); Depression in Dementia (4 weeks); Mood and behaviour (4 weeks); Agitation (4 weeks); Anxiety (4 weeks); Sleep-disturbed behaviours (4 weeks); Sleep-Actigraphy (4 weeks); Disease severity in advanced stages of dementia. (4 weeks); Mood and behaviour during, preceding and immediately after the sessions (4 weeks); Mean Heart rate (4 weeks); Percentage of Oxygen saturation (4 weeks)
C: Pittsburgh Sleep Quality Index (8 weeks)
D: Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement. (Baseline and Week 4.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
Brief Summary: The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.


Options:
A: Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) (Baseline and 12 weeks (or last observation after baseline)); Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) (12 weeks (or last observation after baseline))
B: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
C: Change in the number of apnea/hypopnea episodes during a sleep study (Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.)
D: Polysomnography parameters: respiratory parameters, sleep structure (baseline, 28 days, 15 days, 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
Brief Summary: The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.


Options:
A: Change in cognition and function after 24 weeks.
B: Cohen Mansfield Agitation Inventory
C: Change From Baseline to Week 24 in SIB Total Score (Baseline and Week 24); Overall Change From Baseline in Modified CIBIC+ to Week 24 (Baseline and Week 24)
D: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
Brief Summary: This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Options:
A: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
B: Change in glucose tolerance (from baseline to 52 wks, 53 wks, 260 wks, and 261 wks)
C: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
D: Change in Reactive Hyperemic Index Over the 3-month Treatment Period (Change from baseline to 3 months)

Answer: C