TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
Brief Summary: Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.

Primary Objective(s):

Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.

Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).


Options:
A: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
B: 6 Month 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, assessed up to 6 months)
C: Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup (Baseline until death (up to approximately 38 months overall)); OS in the Intent-To-Treat (ITT) Population (Baseline until death (up to approximately 38 months overall))
D: Progression-Free Survival (PFS) (Randomization to measured PD or date of death from any cause (up to Month 25.0))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
Brief Summary: Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.

Primary Objective(s):

Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX.

Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Overall survival (every course for first three courses, then every other course)
C: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
D: Overall Survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Clinical Trial of Efficacy and Safety of Individual Cognitive Behavioral Therapy (CBT) Within the Setting of the Structured Therapy Program sTCP (Structured Tinnitus Care Program) in Patients With Tinnitus Aurium
Brief Summary: Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.


Options:
A: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) (Last session)
B: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
C: Tinnitus Questionnaire German Version; Tinnitus diary
D: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (18 months); MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Brief Summary: The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.


Options:
A: symptoms related to posttraumatic stress disorder
B: length of stay and depression (ICU admission, Day 5, discharge, and 2 months)
C: Hospital Anxiety and Depression Scale (Day 90)
D: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Brief Summary: The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.


Options:
A: Evaluation of understanding at day 5 by a method of reformulation questionnaire (5th day after inclusion); Scale of satisfaction out of intensive care. (3 months and at one yearfter inclusion)
B: Quality of Communication (QOC) scale (At 6 months)
C: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
D: quality of communication (1 month after intervention completed)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Brief Summary: The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.


Options:
A: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
B: Hospital Anxiety and Depression Scale (Day 90)
C: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
D: Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury (The investigators assessed at baseline, 1-, 3-, and 6-month.); Change in Depression Symptoms Over the Course of the Six Months After Injury (The investigators assessed at baseline, 1-, 3-, and 6-month.); Technology Use (Baseline to 6 months); Feasibility/Acceptability of Intervention (Baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Brief Summary: The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.


Options:
A: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
B: Performance of non-technical skills of the teams. (1 year)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: Composite of readmission to hospital or death. (30 days after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III STUDY OF SECOND-LINE CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB IN METASTATIC COLORECTAL CANCER PATIENTS WHO HAVE RECEIVED FIRST-LINE CHEMOTHERAPY PLUS BEVACIZUMAB.
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with or without bevacizumab in treating metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying second-line combination chemotherapy to see how well it works compared with or without bevacizumab in treating patients with metastatic colorectal cancer who have received first-line chemotherapy and bevacizumab.


Options:
A: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
B: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
C: Progression-free survival (last progression of the last patient)
D: Progression-free Survival (PFS) (From randomization up to 65 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC.


Options:
A: ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (54 months)
B: 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.)
C: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
D: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC.


Options:
A: Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC) (Up to 23 months after first subject randomized)
B: Progression Free Survival (2 3/4 years)
C: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
D: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs
Brief Summary: The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.

Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.

LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.

In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.

Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.

Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.


Options:
A: Peak Walking Time (at 6 months)
B: Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. (4 months)
C: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
D: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)
Brief Summary: "Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.


Options:
A: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
B: Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES). (Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.)
C: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)
D: change in physical activity (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Health Research Center: Smoking, Latinos, and the Web
Brief Summary: The purpose of this study is to determine the percentage of English- and Spanish-speaking smokers worldwide who can stop smoking using an Internet stop smoking site.

Latinos and non-Latinos are welcome to participate.

We will stop recruitment on March 19, 2011. Participants will be able to use the site until May 19, 2011.


Options:
A: Smoking cessation (14 months post baseline)
B: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)
C: Number of smokers referred to tobacco cessation website (12 months)
D: Smoking abstinence (1, 3, 6 and 12 month follow-ups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
Brief Summary: Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested.

The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter.

To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
C: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: C